Registration Dossier
Registration Dossier
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EC number: 402-030-3 | CAS number: 624-86-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
In a dermal sensitization study with an aqueous solution containing 50 % (w/v) Substance H109360 (45% O-ethylhydroxylamine and approximately 5% ethanol), Dunkin-Hartley guinea pigs weighing 317-375 g were tested according to a method equivalent and similar to that described in OECD TG 406 (Skin Sensitisation). The control group contained 10 animals. 20 guinea pigs were used in the test group. Intradermal injections (0.05-0.1 ml) were performed with 3% of the test substance in water while topical inductions (0.2-3.0 ml) were carried out under occlusive conditions, 1 week after intradermal injections with 10% of the Substance H109360 in water. 2 weeks after topical induction exposure, challenge was performed epicutaneously (occlusive; 0.5 ml/animal) with 50% and 30% of Substance H109360 in water for a duration of 24 hours. Evaluation for sentisation was performed 24 and 48 hours post termination of exposure. No data on historical or positive control was given. Only 19 animals were evaluated since one animal lost treatment dressing (bandage) before end of the exposure period. This animal gave a negative result. No skin irritations were noticed in all animals of the control and animals challenged with 30% of the test substance. 3/19 (16%) animals treated with 50% of Substance H109360 gave positive results for skin sensitization (Central Toxicology Laboratories, 1987).
Migrated from Short description of key information:
Skin sensitization: The test substance does not cause contact skin sensitisation in the guinea pig maximization test.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
3/19 (16%) animals treated with 50% of Substance H109360 gave positive results for skin sensitization. This percentage is however lower than the threshold of 30% required for classification according to the 67/548/EEC Annex VI.
Justification for classification or non-classification
Skin sensitization
Ethoxyamine is listed in Annex I of EU Directive No. 67/548/EEC with the classification "may cause sensitisation by skin contact" (R43) and in Annex VI of EU Directive No. 1272/2008 with the classification "may cause allergic skin reaction" (Cat 1). These classifications will be maintained.
Respiratory Sensitization
No classifcation possible due to lack of data
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