Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Endpoint summary
Administrative data
Description of key information
LD50 rat oral > 2000 mg/kg bw.
LD50 mice oral > 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the preliminary experiment of an in vivo mammalian erythrocyte micronucleus test in mice (performed according to the OECD 474 and in compliance to GLP), 4 animals (2 males and 2 females) were treated orally with 2000 mg/kg of the test item and observed for 48 hours. Toxic effects were observed in none of the mice. Even though in this study a value for LD50 was non explicitly reported, a LD50 > 2000 mg/kg bw can be derived based on the results for the oral route.
Moreover, the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP, 2004) and EFSA (in the Scientific Opinion on the re-evaluation of the substance as a food additive, 2009) report the following LD50 values for the substance via the oral route: LD50 for rats > 2000 mg/kg bw, LD50 for rats > 5000 mg/kg, LD50 for dogs > 1000 mg/kg bw, thus confirming that the acute oral toxicity of the test item is low.
Acute toxicity study via inhalation route does not need to be performed as exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance as well as the particles size.
With regards to the acute toxicity via the dermal route, the study does not need to be conducted as the substance is not expected to be significantly absorbed through the skin based on its physicochemical properties and on results from an ex vivo skin absorption study on dissected porcine ear skin. Moreover, according to Annex IV of Regulation EC No. 1223/2009, the substance is allowed as colorant in cosmetic products; the use of the substance for the formulation of cosmetic products supports its low toxicity profile when applied topically on skin.
Justification for classification or non-classification
The low toxicity by oral route (LD50 > 2000 mg/kg in mice and rats) in addition to the authorisation of the substance as food additive indicates a very low toxicity when the substance is administered orally. Based on this, the substance shall not be classified for acute toxicity via the oral route according to the CLP Regulation (EC No. 1272/2008).
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