Registration Dossier
Registration Dossier
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EC number: 443-940-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The available data suggest that test substance is non irritant to skin where as it showed potential risk of serious damage to eyes.
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
Skin irritation:
A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4., OECD Guideline 404 and OPPTS 870.2500.
Three animals were treated with 0.5 g of the test substance moistened in 0.28 mL sesame oil using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal.
No signs of irritation were observed during the whole observation period. No clinical signs of systemic toxicity were observed. The test substance was considered to be non-irritating to rabbit skin (Dr. Kauffmann HM, 2002).
Eye irritation:
A study was conducted to assess the eye irritation potential of test substance to the rabbit eye according to EU Method B.5., OECD Guideline 405 and OPPTS 870.2400.
One animal received 100 mg of an undiluted test substance into conjunctival sac of the left eye. The other eyes served as untreated control. 24 h after the administration the eyes were washed thoroughly with isotonic saline at 37 °C. The eyes were also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.
The eyes were examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7, 14 and 21 d, the eyes were further examined for cornea/lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically (Scale for scoring ocular reactions). All other changes or toxic effects were recorded when apparent.
One hour after administration the conjunctiva of the animal showed slight swelling (including nictitating membrane) and some blood vessels were definitely hyperaemic (injected). Additionally, serous discharge discolored by the test compound with moistening of the lids and hairs just adjacent to the lids was noted. 24 h up to 48 h after administration the conjunctiva of the animal still showed some blood vessels which were definitely hyperaemic (injected). 72 h after administration a slight swelling of the conjunctiva was observed again. 24 h up to 21d after administration the nictitating membrane was discolored by the test compound. This discoloration was not reversible and the study was terminated at Day 21 after administration (Dr. Kauffmann HM, 2002).
Under the test conditions, the test substance showed potential risk of serious damage to the rabbit eye due to the persistent discoloration of the eye according to Council Directive 67/548/EEC.
According to the new CLP regulation (Regulation (EC) No 1272/2008), the susbtance has to be evaluated as not irritating to eyes.
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Skin
Based on the available in vivo skin irritation study, test substance was found to be non-irritating to skin and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).
Eye
Council Directive 67/548/EEC: Based on the availablein vivoeye irritation study, test substance showed potential risk of serious damage to the rabbit eye due to the persistent discoloration of the nictitating membrane.
According to the new CLP regulation (Regulation (EC) No 1272/2008), the susbtance has to be evaluated as not irritating to eyes.
The classification according to Council Directive 67/548/EEC and according to Regulation (EC) No 1272/2008 differs due to changes in the criteria for eye irritation in the new CLP regulation. The substance was classifies as "Xi Risk phrases: R41" due to persistent (21 days) discoloration of the nictitating membrane of one rabbit. In the new CLP regulation, the criteria to serious eye damage was reversed to "discoloration of the cornea", hence, this dye substance has no longer to be classified to be hazardeous to eyes according to REGULATION (EC) No 1272/2008.
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