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JamesP1975  
#1 Posted : 26 March 2015 10:38:06(UTC)
Rank: New forum user
JamesP1975

So I have this MSDS for a material, from a US supplier so it is in the US format, sorry about that, but there appear to be some discrepancies in it. Section 2, Hazards Identification, tell me that it is fairly benign (may be harmful if inhaled, may cause eye irritation). The rest of the MSDS gives me no cause for concern. Until, however, I get to Section 15, Regulatory Information, which states: California Prop. 65 Components: WARNING! This product contains a chemical known to the State of California to cause cancer. WARNING! This product contains a chemical known to the State of California to cause birth defects or other reproductive harm. Other states by the way (Massachusetts, New Jersey, and Pennsylvania) appear to have no problem with the material. So what is going on here? Does the State of California know something that everybody else doesn't know? Or is this an extreme "oh my god, synthetic chemical! It must be carcinogenic!" reaction? Thanks, James.
Jane Blunt  
#2 Posted : 26 March 2015 10:52:59(UTC)
Rank: Super forum user
Jane Blunt

JamesP1975 wrote:
So what is going on here? Does the State of California know something that everybody else doesn't know? Or is this an extreme "oh my god, synthetic chemical! It must be carcinogenic!" reaction?
What is it? I did note that cafes in California had cancer warnings on the doors when I was there in the 1990s. This may be relevant: http://www.cancer.org/ca...lifornias-proposition-65
A Kurdziel  
#3 Posted : 26 March 2015 10:58:05(UTC)
Rank: Super forum user
A Kurdziel

There are different definitions of a carcinogen. A carcinogen is a substance with the POTENTIAL to cause cancer. It’s not like sulphuric acid: if you get that on your skin it will burn. Carcinogens are defined by the strength of evidence that they can cause cancer. This comes from animal studies, human epidemiology, modelling (ie making a assumption based on the structure of the substance concerned and how similar it is to other carcinogens), testing on cell cultures and others. How you weigh up this evidence varies from jurisdiction to jurisdiction. In California they apparently accept less proof than in some places. Really if you are using the stuff in the EU you should be looking at the EU specifications not the Californian ones.
JamesP1975  
#4 Posted : 26 March 2015 11:09:07(UTC)
Rank: New forum user
JamesP1975

This is the material: http://bio.lonza.com/upl...aSheets_Dantocol_DHE.pdf Thanks Jane, that is useful. I have just gone to the oehha.gov.ca website and downloaded their Excel spreadsheet of Prop 65 listed materials, but can't find my stuff on it either searching by chemical name or CAS number. Yes we're using the stuff in the EU, but this is the only datasheet that I have at the moment (not sure if we get one in the EU format or not, will need to look into that).
SBH  
#5 Posted : 26 March 2015 11:15:57(UTC)
Rank: Super forum user
SBH

Its OK referring to the MSDS, but what is the process involved and is there any exposure to users and in what quantities, and what are the controls, if everything is in place is it carcinogenic and of course is there alternative product available. MSDS is not a risk assessment SBH
JamesP1975  
#6 Posted : 26 March 2015 11:27:22(UTC)
Rank: New forum user
JamesP1975

Yes I am aware that an MSDS is not a risk assessment, but I can't put proportionate controls in place if I don't understand the hazards of the material (i.e. is it carcinogenic or not?). Currently there are no special controls in place - the guys wear nitrile gloves, eye protection, and overalls/lab coats. The building is well ventilated. Standard stuff. But, if the material is indeed carcinogenic (as the State of California might or might not think), I might want to consider extra controls. Having an ambiguous MSDS does not help with that decision...
Ian Bell  
#7 Posted : 26 March 2015 11:48:46(UTC)
Rank: Super forum user
Ian Bell

As other have said - it depends upon which definitions you use and risk acceptance criteria used to make the judgement about the cancer risks. If you can, I would take the basic hazardous substances/chemicals information you have - maybe use the CAS number if the product has one, and then use the European GHS system to identify the chemical/substance acute and chronic risks, flammability risks etc (if applicable). Where possible, use European standards etc
Graham  
#8 Posted : 26 March 2015 12:04:51(UTC)
Rank: Forum user
Graham

These Californians are remarkable they say this reagent is 'known' (only to them) to cause cancer, although no one else seems to think so. This looks like an ACE (Backside Covering Exercise) by the litigious yanks. From what you’ve said it sounds like you have sensible processes in place already. On another note this is one of my big problems with MSDS’s. If I read one about a substance I know well it often suggests over the top precautions such as breathing apparatus in case of fire, which is totally irrelevant for what I’m doing (believe me I know). But then I get something that I know nothing about and it says the same thing, so where does that leave me. Do I treat as the reagent I know, or do I follow the instructions to the letter, which of course leaves me open to criticism of my management of the reagent I know. I just ask someone who uses the reagent I don’t know about, there should be a reason why the new reagent is being used, so where did the idea come from, that’s where I start. But it makes a mockery of safety data sheets.
hilary  
#9 Posted : 26 March 2015 12:36:39(UTC)
Rank: Super forum user
hilary

One thing I found about products in general and the MSDS that accompanies them is that the chemical make up of a product changes from country to country. Although it may be called the same, the ingredients may be very very different, so using an MSDS from the US may not be assessing a product you bought in the UK. The State of California is the most advanced in Environmental and Health and Safety considerations - to the point of being completely ridiculous. Check the CAS number against the EH40 (or even google the number) and you should find the definitive answer.
JamesP1975  
#10 Posted : 26 March 2015 13:12:57(UTC)
Rank: New forum user
JamesP1975

Thanks for the input folks. I have just looked at EH40 and my substance is not listed on there; I'm not actually in the UK these days, I'm in Italy, but I figure if it isn't on EH40 it is most likely not of great concern. In fact I've just found an EU document listing it as an ingredient in cosmetics, so if you're allowed to smear it on your face I figure it can't be all that harmful. As I said, I feel that we already have sensible controls in place (PPE and a well ventilated building) so as long as the guys don't snort it (you'd be hard pressed, it's a fairly viscous liquid) or rub it in your eyes, it is fairly benign. I think my original post was more out of curiousity; my thoughts were similar to Graham and Hilary that the Californian statement was an ACE...
chris.packham  
#11 Posted : 26 March 2015 17:27:11(UTC)
Rank: Super forum user
chris.packham

Oh, those wonderful documents known as safety data sheets. I must admit that I tend to file them under 'works of fiction'! A study by the European Chemicals Agency (ECHA), the organisation responsible for REACH, found that of 1,181 companies they inspected in 29 countries, mostly ‘downstream users’, i.e. formulators, regarding compliance with REACH, 52% were producing safety data sheets described in the study as ‘deficient’. ECHA – REACH-EN-FORCE2 My first question is: Who is the importer into the EU. Unless the quantity is minimal, then they should have registered the substance under REACH. They have an absolute duty under REACH to provide a REACH compliant safety data sheet. So are you purchasing this in the EU, in which case it is the duty of the person you are purchasing it from to provide you with the safety data sheet. If you are importing it direct from the USA then the whole REACH regulation falls on you. If the latter is the case, then I strongly suggest that you obtain appropriate professional advice. Happy to follow this up with you off the forum if you wish to PM me with your contact details. Chris
jay  
#12 Posted : 26 March 2015 18:27:17(UTC)
Rank: Super forum user
jay

Why are you referring to Section 15, when the key Hazard infoprmation is in Section 2 (Always nowadays) , and the toxicological information is in section 11--none of which refers to Carcinogenity. You need to refer to what California Proposition 65 is --link below http://oehha.ca.gov/prop...background/p65plain.html As such from June 2015, USA-OSHA will also change over to GHS compliant SDSs and they will have to use hazard statements /safety statements pretty much like Europe-CLP
jay  
#13 Posted : 26 March 2015 18:40:31(UTC)
Rank: Super forum user
jay

Sorry, it seems you have already referred to the list and then should be aware how the list is compiled and its criteria. One entry is, "Alcoholic beverages, when associated with alcohol abuse--cancer --entry date July 1, 1988. The best you can do is refer it back to the supplier/manufacturer and query why they have referred to Carlifonia Proposition 65 when none of the components are in the list???
jay  
#14 Posted : 26 March 2015 18:49:22(UTC)
Rank: Super forum user
jay

Chris, I totally respect your knowledge and expertise, especially on matters related to skin. However, the SDS for the majority of users is going to be the primary source of information and not all have access to learned journals or to "Product Stewardship" departments which large chemical companies tend to have , where there is mix of occupational hygienists, toxicologists and specialkist databases etc. The answer lies in knowing what section of the SDS has what relevant information. One can cross reference with other "lists" such as EH 40 etc . Even the HSE in its COSHH Assessment Tool uses data from EU compliant SDS.
chris.packham  
#15 Posted : 26 March 2015 20:17:10(UTC)
Rank: Super forum user
chris.packham

Jay The problem with the safety data sheet, even if accurate, is that it only lists those chemicals that have been allocated a Hazard statement. There are thousands of chemicals that will not have been so identified and thus will probably never appear on the safety data sheet but that can cause damage to health, particularly through skin contact. The latest guide to patch testing for skin allergies lists 4,350 sensitisers, the vast majority of which will not have been allocated H317 and so will not appear on the safety data sheet. COSHH actually recognises this. In its definition of a hazardous substance it includes: “(e) which, not being a substance falling within sub-paragraphs (a) to (d), because of its chemical or toxicological properties and the way it is used or is present at the workplace creates a risk to health” COSHH Regulation 2 (1) Interpretation In effect, any chemical can become a hazard to health. This is correct. Water in the form of wet work is the most common cause of occupational contact dermatitis. And if you consult the latest ACoP for COSHH you will find statements such as: -- Paragraph 57 - The risk assessment should consider the work activity, including: all the substances hazardous to health (including biological agents, and simple asphyxiants) arising from the work (used, produced, synthesised, created as waste or by-products, or released from processes or during accidents, incidents and emergencies); work done by sub-contractors, at the workplace, that may exposure employees to substances hazardous to health. -- Paragraph 67 - It may be necessary to collect information on the properties and attributes of substances hazardous to health from a variety of sources to fully inform the assessment process -- Paragraph 35 states: When deciding whether the substances used or produced in the workplace are covered by COSHH, employers should also consider the following: Different forms of a substance may present different hazards, eg substances may not be hazardous in solid form but may be hazardous when ground into fine powder or dust that can be breathed into the lungs. Nanoparticles (ie particles less than 100 nanometers) may be more toxic than larger particles of the same chemical substance. Impurities in a substance can make it more hazardous, eg crystalline silica is often present in minerals which would otherwise present little or no hazard. Some substances have a fibrous form which may present a potentially serious risk to health if the fibres are of a certain size or shape. Some substances have a known health effect but the mechanism causing it is unknown, eg certain dusts of textile raw materials cause byssinosis. Exposure to two or more substances at the same time or one after the other may have an added or synergistic effect. Epidemiological or other data, eg reports of illness due to new and emerging agents, indicate that a biological agent that does not already appear in The Approved List of biological agents could nevertheless cause a hazard to health. One-off, emergency situations arising out of the work activity, such as a dangerous chemical reaction or fire, could foreseeably produce a substance hazardous to health. ‘Wet work’ is one of the most frequently and consistently reported causes of irritant occupational contact dermatitis. ‘Wet work’ is the term used to describe tasks involving prolonged or frequent contact with water, particularly in combination with soaps and detergents. -- In other words, the HSE has moved away from reliance on the safety data sheet - actually correctly. Whilst I have sympathy for those who don't have the necessary expertise themselves, the simple fact is that in my work I encounter many risk assessments, based on the safety data sheet, that are actually putting worker health at risk. If you can get hold of a copy of the latest issue of the BOHS journal 'Exposure' there is an article (Chemicals - what might we be missing?' that covers this is some depth. If you cannot, drop me a PM with your e-mail address and I will see if I can let you have a copy of the article. Chris
John D C  
#16 Posted : 26 March 2015 21:11:03(UTC)
Rank: Super forum user
John D C

If a company sells a product in California that is found to have the slightest chance of causing cancer and it is not labelled as such the fine is quite heavy but the fine that follows for each day the unlabelled product is still out there is even higher as the company has to prove it has removed all of it. When I worked with a local authority the Grounds Maintenance team had inherited from a school a synthetic sports field cleaning machine. It just looked like a small tractor with roller brushes but on the dashboard was a label warning that use of the machine could cause cancer. Needless to say no-one had used it since getting it from the school. My investigations showed the machine had been imported from the USA. It was the tiny tiny amount of benzene (a known carcinogen) that is present in petrol that meant it had to beleaguered to satisfy California proposition 65 even though the amount in any thankful was insignificant. If you read the data sheet it is very specific that no carcinogenic properties are recognised anywhere except California. Just ignore anything re Proposition 65, or start labelling bottles of beer, some food additives.
Roundtuit  
#17 Posted : 26 March 2015 22:10:12(UTC)
Rank: Super forum user
Roundtuit

Unfortunately California has two versions of its Prop 65 listing a public version which is readily available AND the one associated with items the manufacturer / supplier has denoted as "trade secret" (another area where US implementation of GHS is not going to be either global or harmonised). Section 2 and 3 of the received MSDS may not identify a substance thanks to trade secret so only the declaration in section 15 identifies its presence. Talcum powder is a carcinogen according to ACGIH - erroneous data based upon possible Asbestos content from the abstraction process and guess what "known to the state of California to cause cancer" So EU use = EU SDS - If you are in Italy insist on a supplier SDS to the local regulations which would soon be CLP with any national exposure limits e.g. EH40 for the UK market.
Roundtuit  
#18 Posted : 26 March 2015 22:10:12(UTC)
Rank: Super forum user
Roundtuit

Unfortunately California has two versions of its Prop 65 listing a public version which is readily available AND the one associated with items the manufacturer / supplier has denoted as "trade secret" (another area where US implementation of GHS is not going to be either global or harmonised). Section 2 and 3 of the received MSDS may not identify a substance thanks to trade secret so only the declaration in section 15 identifies its presence. Talcum powder is a carcinogen according to ACGIH - erroneous data based upon possible Asbestos content from the abstraction process and guess what "known to the state of California to cause cancer" So EU use = EU SDS - If you are in Italy insist on a supplier SDS to the local regulations which would soon be CLP with any national exposure limits e.g. EH40 for the UK market.
chris.packham  
#19 Posted : 27 March 2015 07:26:11(UTC)
Rank: Super forum user
chris.packham

As I understand it EH40 is merely a listing of those substances that have been assigned a WEL. It is certainly not a full listing of all those substances that have been accorded a Hazard Statement. EH40 only deals with inhalation hazards, with a notation for those substances that have been assigned a WEL and can also penetrate the skin (sk). There are thousands of substances in use today that have a Hazard Statement assigned to them that do not appear in EH40. The CLP regulation has a much more extensive list, but even this is far from comprehensive. Furthermore, there are many substances that have not been assigned a Hazard Statement but can become a hazard depending upon how they are used (see COSHH definition (e) as shown in my earlier posting and the guidance in the 6th edition of the ACoP for COSHH). Chris
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