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EC number: 204-574-5 | CAS number: 122-78-1
Skin sensitisation (OECD 429): sensitising
The skin sensitising potential of the test substance was evaluated in a LLNA test according to OECD 429 (2001).The study was conducted on four female mice per dose group (1, 2.5, 5, 10 and 25% w/v). Each animal received 25 µL of the substance to the dorsum of each ear. Animals were treated once daily for three consecutive days. Five days after initiation of exposure, all animals were injected with tritiated methyl-thymidine in the tail vein. Five hours later, animals were sacrificed, and the draining auricular lymph nodes removed and prepared for cell suspension and scintillation counting. A vehicle control (4:1 v/v acetone:olive oil) group was run concurrently. The test substance produced stimulation indices of 0.73, 1.76, 7.84, 8.76 and 18.96 at concentrations of 1, 2.5, 5, 10 and 25% (w/v) in 4:1 v/v acetone:olive oil, respectively and a EC3 value of 3.0% was calculated. Therefore the test substance was considered to be a moderate sensitiser.
Two additional publications are available (Klecak et al., 1977 and Ryan et al., 2000; not included as robust study summary in IUCLID) showing sensitising properties of the test substance. Klecak et al. summarises four different studies in guinea pigs (open epicutaneous test, Draize test, maximisation test and an intradermal test with Freund´s complete adjuvant) all showing sensitising properties of the test substance at different concentrations and undiluted, repectively (1977). In the OET a minimum sensitizing concentration of 0.3% and a minimum eliciting concentration of 0.03% were determined. Ryan et al. showed sensitising properties of the test substance in an murine local lymph node assay where stimulation indices of > 3 were produced at all tested concentrations (25, 50 and 100% (w/v) in acetone:olive oil) (2000).
In conclusion, the test substance is considered to be a weak skin sensitiser with regard to the criteria of the CLP regulation (Skin Sens. 1B).
Klecak, G. et al. (1977): Screening of fragrance materials for allergenicity in the guinea pig. Journal of the Society of Cosmetic Chemists, Vol. 28, pp. 53 - 64
Ryan, C. A. et al. (2000): Activity of human contact allergens in the murine local lymph node assay. Contact Dermatitis, Vol. 43, pp. 95 - 102
The available data on skin sensitisation of the test substance meet the criteria for classification as Skin Sens 1B (H317) according to Regulation (EC) No 1272/2008.
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