Registration Dossier
Registration Dossier
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EC number: 423-070-8 | CAS number: 58890-25-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
KY-RB was tested in two adjuvant type guinea pig test methods for skin sensitisation according to OECD 406 guideline and GLP principles.
In the first study, no mortality occurred and no symptoms of systemic toxicity were observed in the animals. Five test group animals showed slight erythema after the 48 hours occluded epidermal induction exposure. Two out of ten test substance group animals showed a positive reaction in response to the 25%, 10% and 5% KY-RB challenge concentrations (sensitisation rate of 20%). Reliable negative and positive controls were included.
In the second study, no mortality occurred and no symptoms of systemic toxicity were observed in the animals.The intradermal injections resulted in an acceptable level of necrosis. None of the ten test substance group animals showed a positive reaction in response to the 25% KY-RB challenge concentrations (sensitisation rate of 0%). Reliable negative and positive controls were included.
Migrated from Short description of key information:
Two GPMT studies were performed according to OECD 406 guideline and GLP principles. Based on the results of both studies, the substance is not sensitising to the skin.
Justification for selection of skin sensitisation endpoint:
No study was selected, both key studies has been used for the conslusion on C&L.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the studies, the substance KY-RB does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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