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EC number: 947-726-2 | CAS number: -
The dermal reactions observed in the test animals were considered to be similar to or less marked than the maximum reaction observed in animals of the control group. Some localised dermal reactions were observed, and dryness and sloughing of the epidermis.
The potential of the substance to induce delayed contact hypersensitivity was assessed in guinea pigs using the technical grade dihydrogenatedtallowdimethylammonium chloride (78% active in isopropanol/water). The study was performed according to a method equivalent to the OECD guideline 406 and a statement that the report and the study were audited by the Quality Assurance Unit of the testing laboratory was provided.
The induction phase was realized both by intradermal route on day 1 (Test substance 0.1 % v/v in water for injection) and by cutaneous route on day 8 (Test substance 10% v/v in distilled water ) in 2 groups of guinea pigs: 15 males for control group and 15 males for treated group. The challenge phase was realized on day 22 by cutaneous application of the test substance at 2.5% and 1% v/v in distilled water on two sites on the left flank . the cutaneous reactions were scored 24 ,48 and 72 hours after the challenge phase.
After the challenge application with 2.5 % v/v of the test substance in distilled water, erythema grade 1 or 2 were observed in 7, 4 and 3 controls animals at the 24, 48 and 72-hours readings respectively. 1 control animal showed also oedema. In the treated group, the incidence and severitiy of the cutaneous reactions were quite similar: 10, 7 and 5 treated animals showed erythema grade 1 or 2 at the 24, 48 and 72-hours readings. 2 treated animals showed oedema.
After the challenge application with 1% v/v of the test substance, an erythema ( grade 1 or 2) was observed in 3 ,2 and 1 out the 15 animals of the treated group at the 24, 48 and 72-hour readings respectively. In the control group, 1animal showed an erythema grade 1at the 24 -hour reading.
The persistent cutaneous reactions observed in 3/15 animals of the treated group after the challenge application may be attributable to delayed contact hypersensitivity but as the cutaneous reactions were more confined to the 24 hour examination, they were more consistent with irritation than delayed contact hypersensitivity.
Therefore, the cutaneous reactions observed in 3/15 animals (20%) of the treated groups were considered as irritative response and the substance was not considered as a skin sensitiser.
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