Registration Dossier

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:

The potential of the test material to be a contact sensitiser was investigated in a study conducted in accordance with methodology broadly equivalent to the standardised guideline OECD 406. It was assigned a reliability score of 2 in accordance with the criteria detailed by Klimisch (1997).

The test material was applied at a concentration of 25 % (v/v) in SX-10 Base Oil in 0.3 mL doses to the shaved backs of ten guinea pigs once per week during an induction period of three weeks. Two and three weeks following the induction period, the treated guinea pigs, along with ten control guinea pigs, received a challenge dose of 0.3 mL of the test material at a 0.1 % concentration (v/v) in light mineral oil at different sites on the back. All guinea pigs were scored for erythema approximately 24 and 48 hours following the application of each challenge dose.

Positive erythema reactions (i.e. a score ≥2) were not observed in any of the treated or control guinea pigs following either challenge.

Under the conditions of this study the test material was determined not to be a sensitiser and therefore requires no classification in accordance with EU criteria.

Migrated from Short description of key information:
In a Buehler test, the test material was determined to be a non-sensitiser.

Justification for selection of skin sensitisation endpoint:
Only one study 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 (EC) No. 1272/2008, the test material does not require classification for sensitisation.