Registration Dossier

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:
Justification for selection of skin sensitisation endpoint:
This study was conducted to evaluate the skin sensitisation of Red 620 in guinea pigs by Buehler test. Parameters measured during the study period were mortality, clinical signs, body weight changes and skin reactions. The following results were obtained.
- No treatment-related mortality was observed during the study period.
- No treatment-related clinical signs were observed in any treated animals.
- In body weight changes, all living animals in treatment group showed normal increase of body weight during the study period. But in positive control group, 2 animals (Animal No. 1303, 1309) were temporarily decreased.
- At the 24 and 48 hours after challenge with test substance of 25%(w/v), the sensitisation index (mean score of skin reaction) and frequency index (sensitisation rate) were '0.0', '0.0' and '0. 0% at 24 and 48 hours for the test substance. In positive control, the sensitisation index (mean score of skin reaction) and frequency index (sensitisation rate) were '1.3', '0.9' and '90.0 %', '80.0 %' at 24 and 48 hours after challenge, respectively.
These results indicate that this test substance is considered to have no skin sensitizing potency of Red 620 in guinea pigs by Buehler test under the conditions of this study.

Justification for classification or non-classification