Registration Dossier
Registration Dossier
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EC number: 404-450-2 | CAS number: 118685-34-0 COBRATEC 435
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
One test animal was killed in extremis during the induction period. Signs of ill health inctuded noisy respiration, gasping, dark
eyes and lethargy. Autopsy revealed complete consolidation of anterior lung lobes with patchy consolidation of posterior lobes and pallor of liver: and kidneys. Death was not considered to be related to treatment.
One test animal was found dead prior to the challenge application. Tthe animal was autolysed and cannibalised and the cause of death could not be determined.
The bandage of a further one test animal came off prematurely. This animal was excluded from the final assessment.
The dermal reactions seen in six test animals were more marked than those seen in the controls.
In one further animal the dermal reactions were slightly more marked but not clearly different, from those seen in the controls.
The dermal response seen in the remaining ten animals was similar to the controls.
Migrated from Short description of key information:
In this study, Butyl benzotriazole - sodium salt 37% solution produced evidence of skin sensitisation (delayed contact hypersensitivity) in six test animals.
Justification for selection of skin sensitisation endpoint:
In this study, Butyl benzotriazole - sodium salt 37% solution produced evidence of skin sensitisation (delayed contact hypersensitivity) in six test animals. So, Butyl benzotriazole - sodium saIt 37% solution requires Iabelling the risk phrase with R43 "May cause sensitisation by skin contact" in accordance with the Directive 67/548/EEC and Hazardous Statement H317 "May cause an allergie skin reaction" in accordance with the regulation (EC) 1272/2008
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In this study, Butyl benzotriazole - sodium salt 37% solution produced evidence of skin sensitisation (delayed contact hypersensitivity) in six test animals. So, Butyl benzotriazole - sodium saIt 37% solution requires Iabelling the risk phrase with R43 "May cause sensitisation by skin contact" in accordance with the Directive 67/548/EEC and Hazardous Statement H317 "May cause an allergie skin reaction" in accordance with the regulation (EC) 1272/2008
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