Registration Dossier
Registration Dossier
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EC number: 252-240-2 | CAS number: 34840-23-8
Endpoint summary
Administrative data
Description of key information
The acute skin irritation study (patch test) in rabbits was conducted under GLP in accordance with OECD no.404 and EC Guideline B.4 ".
The acute eye irritation study by instillation into the conjunctival sac of rabbits was conducted under GLP in accordance with OECD no.405 and EC Guideline B.5 ".
Testing facility: LPT Laboratory of Pharmacology and Toxicology KG, Hamburg
Study no. T4067768 performed on February 2, 2001.
The registrant has a Letter of Access.
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
In the Acute skin irritation study, Patch-Test, none of the three rabbits exposed for 4 hrs to 500 mg BCI /patch and animal (semi-occlusive condition) showed any substance-related lesions at the examination time-points 60 min, 24, 48 and 72 hours after patch removal. There were no systemic intolerance reactions.
In the Acute eye irritation study a single application of 100 mg BCI per animal into the conjunctival sac of the right eye of three rabbits caused the following effects: the cornea, iris and conjunctivae were not affected by instillation of the test compound. There were no systemic intolerance reactions.
Justification for selection of skin irritation / corrosion endpoint:
One available study
Justification for selection of eye irritation endpoint:
One available study
Justification for classification or non-classification
BCI was not irritating to skin and eyes, hence no labelling is required.
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