Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the results of the read across study, the test substance, C18-22 TMAC, is considered to be non-sensitising.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to determine the sensitization potential of the read across substance, C18 TMAC (active: >97%), according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. The experiment was performed in guinea-pig according to the Buehler test. A pre-test was conducted to determine the non-irritating concentrations to use in the main study. During the induction phase (Days 1 - 15), the test animals were exposed to 0.5 mL of the read across substance at 4% via an occlusive bandage placed on the shaved skin of the left flank. After 6 h, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 h later. On Day 29, the test and control animals were exposed to 0.5 mL of the test substance at 1% via an occlusive bandage placed on the shaved skin of the right flank. On Days 30 and 31, a macroscopic evaluation of the treated skin was made and animal bodyweights were recorded. During the induction phase (Days 1 - 15), animals presented light to clearly defined erythema and very light to clearly defined edema. The skin surfaces were dry and flaky. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 h after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups. During the main test, there were no signs of toxicity and bodyweight gain of the test animals was comparable to that of controls. Under the study conditions, the read across substance was considered to be non-sensitizing to guinea pig (Bury, 1995). Based on the results of the read across study, a similar absence of skin sensitisation potential is expected for the test substance, C18-22 TMAC.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the read across study, the test substance, C18-22 TMAC does not warrant classification for skin sensitisation according to EU CLP criteria (Regulation 1272/2008/EC).
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