Registration Dossier
Registration Dossier
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EC number: 434-280-4 | 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:
Sensitization Study
Following challenge with 10% w/w 434 -280 -4 in mineral oil, U S P, dermal scores of 1 were noted in 5/20 test animals at the 24- and 48-hour scoring intervals. Dermal reactions in the remaining test and challenge control animals were limited to scores of 0 to±.Group mean dermal scores were noted to be higher in the test animals as compared with the challenge control animals.
Following rechallenge with 10% w/w 434 -280 -4 in mineral oil, U S P, dermal scores of 1 were noted in 2/20 test animals at the 24 and 48-hour scoring intervals. Dermal reactions in the remaining test and rechallenge control animals were limited to scores of 0 to±.Group mean dermal scores were noted to be similar in the test animals as compared with the rechallenge control animals.
Two of the 20 (10%) induced animals responded at both challenge and rechallenge. No confounding irritation (no scores>.±) was observed at either challenge. The following animals were considered sensitized: G8658/F and G8659/ F.
Migrated from Short description of key information:
The test substance was assessed for skin sensitisation potential according to OECD Test Guideline 406 using an in vivo method. The substance did not meet the criteria for classification as a skin sensitiser.
Justification for selection of skin sensitisation endpoint:
The study was conducted on the target substance in vivo, in an appropriate test species and according to internationally recognised guidelines.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Sensitization Study
Following challenge with 10% w/w 434 -280 -4 in mineral oil, U S P, dermal scores of 1 were noted in 5/20 test animals at the 24- and 48-hour scoring intervals. Dermal reactions in the remaining test and challenge control animals were limited to scores of 0 to±.Group mean dermal scores were noted to be higher in the test animals as compared with the challenge control animals.
Following rechallenge with 10% w/w 434 -280 -4in mineral oil, U S P, dermal scores of 1 were noted in 2/20 test animals at the 24 and 48-hour scoring intervals. Dermal reactions in the remaining test and rechallenge control animals were limited to scores of 0 to±.Group mean dermal scores were noted to be similar in the test animals as compared with the rechallenge control animals.
Two of the 20 (10%) induced animals responded at both challenge and rechallenge. No confounding irritation (no scores>.±) was observed at either challenge. The following animals were considered sensitized: G8658/F and G8659/ F.
Migrated from Short description of key information:
The test substance was assessed for skin sensitisation potential
according to OECD Test Guideline 406 using an in vivo method. The
substance did not meet the criteria for classification as a skin
sensitiser.
Justification for selection of skin sensitisation endpoint:
The study was conducted on the target substance in vivo, in an
appropriate test species and according to internationally recognised
guidelines.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
