Registration Dossier
Registration Dossier
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EC number: 271-637-1 | CAS number: 68603-10-1
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:
In a Buehler test, the skin sensitisation potential was assessed according to standardised guidelines OECD 406 and EPA OPPTS 870.2600.
Twenty Guinea pigs were exposed to the test material first using three induction exposures at 50 and 40 % w/v, then in a challenge and rechallenge exposure at 25, 20 and 10 % w/v. None of the test animals displayed a dermal reaction greater than the challenge control during the challenge or rechallenge. Under the conditions of the test, the test material was determined to be not sensitising and therefore does not require classification in accordance with EU criteria.
The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. However, the study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.
Read across is justified on the basis of similar chemical structures and analogous results from a batch of physico-chemical tests, including water solubility.
The available data are considered to be complete and the conclusion, not sensitising, was taken forward for risk assessment.
Migrated from Short description of key information:
Not sensitising, male/female Guinea pig, OECD 406, EPA OPPTS 870.2600, Rodabaugh 2001
Justification for selection of skin sensitisation endpoint:
Only one study is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material did not elicit a response in the Buehler test and therefore does not meet the criteria for classification as a skin sensitiser.
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