Registration Dossier
Registration Dossier
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EC number: 604-776-7 | CAS number: 151213-15-9
Endpoint summary
Administrative data
Description of key information
Skin irritation in vivo (Rabbit-Himalayan, GLP, OECD TG 404, EU Method B.4): not irritating to the skin
[Bayer AG, Report No. R 6822, 1997-05-22]
Eye irritation in vivo (Rabbit-Himalayan, GLP, OECD TG 405, EU Method B.5): irritating to the eye
[Bayer AG, Report No. R 6823, 1997-05-22]
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
In the skin irritation test in all 3 animals no signs of skin irritation could be observed. There were no systemic intolerance reactions.
In the eye irritation test corneal opacity (grade 1) was observed in all 3 animals, starting at the examination time point 24 hours after
instillation and lasting until 7 days after instillation in all 3 rabbits, in rabbit no. 1 up to 11 days and in rabbit no.2 up to 8 days after instillation. The fluorescein test performed after 24 hours revealed corneal staining in animal no. 1 and 2 (whole corneal surface) and in animal no. 3 (3/4 of the corneal surface). The fluorescein test performed after 7 days revealed corneal staining in animal nos. 1 and 3 (1/4 of the corneal surface) and in animal no. 2 (3/4 of the corneal surface). All animals showed an irritation of the iris (grade 1) starting 24 hours after instillation and lasting until 6 days after instillation in all 3 rabbits, in animal no. 1 up to 11 days and in animal no. 2 up to 8 days after instillation. Conjunctival redness (grade 1) was observed in rabbit No. 2 and 3 one hour after instillation, in rabbit No. 2 up to 48 hours days after instillation. Conjunctival chemosis (grade 1) was observed in rabbits no. 2 and 3 one and 24 hours after instillation, in animal no. 2 up to 48 hours after instillation.
There were no systemic intolerance reactions.
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the study results for skin irritation a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
Based on the study results for eye irritation Bay Z 7906 has to be classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) with Xi, R36 and Eye Irrit. 2, H319, respectively.
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