Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Methods

The test substance (Carbohydrazide) was tested for skin sensitisation in guinea pigs according to the Magnusson and Kligman Maximisation Method (OECD Guideline 406; EU Method B.6). The doses used at challenge were 75% and 50% test substance in distilled water and reactions were observed after 24 and 48 hours after challenge.

Results

Based on the dose of 75% w/w in distilled water, the test material produced an 89% sensitisation rate.

Conclusion

Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance is considered to be a skin sensitiser to guinea pigs. The study concluded that as the test material produced a sensitisation rate of more than 30%, that the substance requires labelling with the symbol "Xi" and the indication of danger "irritant" and the risk phrase R43 "May cause Sensitisation by Skin Contact".

Based on the study findings, the test substance will be classified under Regulation (EC) No 1272/2008 (CLP) for Skin Sensitisation (Category 1) and is considered to be a moderate skin sensitiser in accordance with the ECHA document "Guidance on the application of the CLP Criteria (Section 3.4.2.3.4.2)".


Migrated from Short description of key information:
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance is considered to be a
skin sensitiser to guinea pigs.

Justification for selection of skin sensitisation endpoint:
The study has been conducted according to OECD Guideline 406 and GLP and is adequately reported. The study has been assigned a reliability 1.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the study findings, the test substance will be classified under Regulation (EC) No 1272/2008 (CLP) for Skin Sensitisation (Category 1 (sub-category 1B) and is considered to be a moderate skin sensitiser in accordance with the ECHA document "Guidance on the application of the CLP Criteria (Section 3.4.2.3.4.2)".