Registration Dossier

Administrative data

Description of key information

Based on the results of the read across study, the test substance is not considered to be sensitising to skin.

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 sensitising potential of read across substance, C16 TMAC (30% active in water) in guinea-pigs according to OECD Guideline 406 (Buehler method) and EU Method B6, in compliance with GLP. 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% w/v via an occlusive bandage placed on the shaved skin of the left flank. After 6 hours, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 hours later. On Day 29, the test and control animals were exposed to 0.5 mL of the read across substance at 1% w/v 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 dermal induction phase (Days 1-5), animals presented light to clearly defined erythema and very light edema. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 hours 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 were comparable to that of the controls. Under the study conditions, the substance was considered to be non-sensitising (Bury D, 1994). Based on the results of the read across study, the test substance is also considered to be non-sensitising to skin.

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 does not warrant a classification for skin sensitisation according to EU CLP criteria (Regulation EC 1272/2008).