Solvent violet 13, a colourant found in a wide range of consumer products including cosmetics and toys, is harmful to human health at current levels of exposure, according to a draft conclusion from the Canadian government.
If confirmed, the conclusion would most likely trigger risk management measures against the substance. However, industry says that the assessment does not take into account the most recent toxicity data available in the solvent violet 13 REACH registration dossier.
The government published a draft screening assessment of seven anthraquinone substances on 3 November. The substances are used as colourants in: cosmetics, food packaging materials, children's arts and crafts materials, toys, do-it-yourself products, and textiles.
The seven substances were originally part of a group of 15 anthraquinones prioritised under the Chemicals Management Plan. The government previously assessed eight of the 15 and found that they were of low concern.
The remaining seven are:
- solvent violet 13;
- pigment blue 60;
- solvent violet 59;
- solvent blue 36;
- disperse red 60;
- acid blue 239; and
- "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl", including methyl- and pentyl- derivatives.
The draft screening assessment of these substances used read-across for the human health hazards owing to a scarcity of health effects data.
It found a potential to cause carcinogenicity for all apart from pigment blue 60 and potential to cause adverse developmental effects for solvent violet 13 and solvent blue 36.
Using carcinogenicity as the critical effect, the assessment concluded that pigment blue 60 meets one of the criteria in section 64 of the Canadian Environmental Protection Act (Cepa).
The assessment used the "ecological risk classification of organic substances" approach to predicting the environmental risks, which was published in 2016 by Environment and Climate Change Canada. This led to the conclusion that all seven substances represented low risk of harm to the environment.
However, Dr Pierfrancesco Fois, deputy executive director at colourants trade association Etad, says that some of the data gaps identified in the assessment can be filled, reducing uncertainty in the risk characterisation.
For example, the assessment suggests that for solvent violet 13 there are no studies covering:
- in vivo genotoxicity;
- developmental or reproductive toxicity; or
- repeated-dose or chronic animal studies for oral exposure.
However, Dr Fois says that the solvent violet 13 REACH registration dossier contains data for:
- an in vivo micronucleus test showing no mutagenicity;
- a reproductive toxicity test via oral route; and
- a repeated dose toxicity test, via oral route.
"Similar additional information exists for other substances in the list," he says. "If we can eliminate, or at least minimise, these sources of uncertainty, we will have an assessment which reflects better the properties of the single substances … Until this process is completed, it is too early for drawing any conclusion on the risk of solvent violet 13."
The government has started a 60-day public consultation, which closes on 2 January.