Registration Dossier
Registration Dossier
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EC number: 441-100-8 | CAS number: 351197-46-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin
The cutaneous allergenic potential of UAX-1179 was investigated in the GPMT (Arcelin, 2002). The study was performed in 15 male albino guinea pigs under GLP in accordance with OECD Guideline No. 406. The test started with an intradermal induction followed by an epidermal induction on test day 8. The intradermal induction was performed by pairs of injections with 0.1 mL test item, at 10% in purified water and the test item at 10% in a 1:1 (v/v) mixture of Freund’s Complete Adjuvant and physiological saline and a third pair with 1:1 (v/v) mixture of Freund’s Complete Adjuvant and physiological saline. The control group were injected the same solutions without test substance. The epidermal induction followed provoking a mild inflammatory reaction by pretreatment with Sodium-Lauryl-Sulfate (SLS). A patch of filter paper was saturated with approximately 0.3 mL of the test item (75% in purified water). The guinea pigs of the control group were treated with purified water only, applied at a volume of approximately 0.3 mL.Ventral recumbency and tremor were observed in four test animals approx. 3 hours after the intradermal induction application. Challenge was performed on test day 22. Two patches of filter paper were saturated with 0.2 mL of the test item at the highest tested non-irritating concentration of 75%. Discrete / patchy to moderate / confluent erythema were observed in all animals at the 24- and 48-hour reading after treatment with the test item at 75% in purified water. No skin effect was observed in the control group. (One animal of the control group and one animal of the test group were found dead on day 11 respectively day 1. The cause of death could not be established.) Based on the findings of an adjuvant sensitization test (Magnusson & Kligman test) in guinea pigs UAX-1179 has to be classified and labelled as a skin sensitizer.
Migrated from Short description of key information:
skin: sensitising (Arcelin, 2002)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
There is no data for Respiratory sensitisation. The exposure of UAX-1179 by inhalation is not likely.
Justification for classification or non-classification
DSD: R43, May cause sensitisation by skin contact
CLP: Skin sens. 1, H317, May cause an allergic skin reaction, with signal word: warning
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