Registration Dossier
Registration Dossier
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EC number: 215-385-2 | CAS number: 1324-76-1
Endpoint summary
Administrative data
Description of key information
skin irritation: method:according to OECD TG 404; result: not irritating to skin.
eye irritation: method: equivalent to OECD TG 405, result: mild irritating 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:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
There was one study focused on investigating skin irritation, due to its high adequate which were performed following OECD test guidelines No.404 and GLP principles.The results of this study showed that test article was not irritant to skin in the rabbit.
Eye irritation:
There were three studies conducted to dermine the potential irritation to eyes of rabbits, which complied with OECD test guidelines 405.
In the key study , test article (0.1 ml equivalent (23.4 mg)) was placed by syringe-type applicator into the conjunctival sac. Animals were also observed for toxicological effects at each dermal observation period and observed for mortality daily. There were no erythema or edema noted at any observation period. There were no abnormal physical signs noted during the observation period. All body weight changes were normal.
In other supporting studies, test article was applied to the eyes of rabbits at level of 100mg more than the dose administered in the key study. One of this two supportive studies, there was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared in one eye by 48 hours, in one eye by 72 hours and in one eye by day 7. Test article is considered to be only mildly irritating to rabbit's eyes as the mean scores of conjunctival irritation < 2 (following grading at 24, 48 and 72 hours after installation of the test material), and which fully reverses within an observation period of 7 days. However, in another supporting study,no signs of ocular irritation were noted at 24, 48 and 72 hours after instillation.
Therefore, we have reason to believe that test article is considered to be a non-irritant to skin and eyes of rabbits.
Justification for classification or non-classification
Based on the available data, test article can not be classified according to CLP(Regulation EC No.1272/2008).
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