Registration Dossier
Registration Dossier
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EC number: 500-057-6 | CAS number: 27104-30-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
One study was available for this endpoint and considered as the key study (SPL, 1992). This study was conducted according to OECD guideline 406 and in compliance with GLP (Kr: 1). Healthy female albino guinea pigs (20 treated + 10 control) were tested using the guinea-pig maximisation test method. The highest not irritant test concentrations (16%, 32%) and and the lowest irritant test concentration (49%) were determined in the preliminary study. The control animals showed the anticipated reactions. THPC-urea produced a 53% (10/19) sensitization rate at challenge readings following topical application at 16%. At a concentration of 32% for topical application, animal exhibited skin irritation.Thus, THPC-urea is considered as a skin sensitizer.
Migrated from Short description of key information:
Positive in GPMT (OECD 406, Kr:1) and therefore classified as a skin sensitizer.
Justification for selection of skin sensitisation endpoint:
GLP Study with a good reliability
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data was available
Migrated from Short description of key information:
No data was available
Justification for classification or non-classification
1- Skin sensitisation:
Based on the positive results in a validated animal test (GPMT); THPC-urea is classified in Category 1A, H317 (may cause an allergic skin reaction) according to the CLP regulation (1272/2008) including ATP2 and as a skin sensitizer (Xi-R43) according to the Directive 67/548/EEC.
2- Respiratory sensitisation:
No classification is possible due to lack of data
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