Registration Dossier
Registration Dossier
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EC number: 417-040-3 | CAS number: -
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:
Maximum concentration not causing irritating effects in preliminary test: 80.4 %
Signs of irritation during induction:
Intradermal injections: Necrosis was recorded at the sites receiving Freund's Complete Adjuvant in the test and control animals.
Slight irritation was seen in test animals at sites receiving Coagulant 122 (solid), 4.02% v/v in water
Topical application:
Slight erythema was observed in test animals following topical application with Coagulant 122 (solid), 80.4% v/v in distilled water and slight erythema was seen in control guinea-pigs.
Evidence of sensitisation of each challenge concentration: None
Other observations:There were no dermal reactions seen in any of the test or control animals (only isolated incidence of localised dermal irritation and/or sloughing seen in two control and four test animals.
No signs of ill health or toxicity were recorded.
Migrated from Short description of key information:
In this study, Coagulant 122 solid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Ten test and five control guinea-pigs were used in this study.
In this study Coagulant 122 solid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the ten test animals. So, Coagulant 122 solid does not require labelling with H317: May cause an allergie skin reaction in accordance with the Regulation (EC) 1272/2008.
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