Registration Dossier
Registration Dossier
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EC number: 943-366-5 | CAS number: -
Endpoint summary
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:
No specific studies have been conducted for the target substance. The substance is composed of acetic anhydride (5-10 wt. %), adipic acid, di-anhydride with bis(acetic acid) (50 -62 wt. %) and acetic acid (30-35 wt. %).The weight of evidence approach is used to determine the sensitization properties of the target substance evaluating relevant data from the constituent of the target substance and from the decomposition products. However, very limited amount of data is available.
No reliable study is conducted for acetic anhydride. In one report local response claimed to be indicative of a sensitization reaction (Jacobs, J.L, 1940). In the study guinea pigs were given twice weekly intracutaneous injections of 0.05 ml of a solution in olive oil for 2-2.5 weeks.However, the report is of poor quality and the documentation is not sufficient for assessment.
There is only one sensitisation study available for adipic acid. It produced no evidence of a sensitising action. Groups of 10 guinea pigs were given series of four sacral intradermal injections, one each week over a three-week period, which consisted of 0.1 ml of a 1.0 % solution of adipic acid (99.99 %) in water. Following a two-week rest period, the test animals were challenged for sensitisation by applying, and lightly rubbing in, approximately 0.05 ml of a 50 % and 25 % suspension of the test material in propylene glycol on the shaved intact shoulder skin. A group of 10 previously unexposed animals received similar applications at the time of challenge to provide direct comparison of the challenge reactions on the skin of similar age. The compound produced very mild to no skin irritation to previously unexposed guinea pigs and did not cause sensitisation (OECD; SIDS (2003).
Migrated from Short description of key information:
No data is available to assess sensitization potential of the target substance. Due to corrosive properties of the target substance and decomposition products further skin sensitization testing would be difficult to justify.
Justification for selection of skin sensitisation endpoint:
No single study was selected since weight of evidence is used to assess the sensitisation properties of the target substance
Justification for classification or non-classification
The target substance is not classified for skin sensitization in accordance to the CLP Regulation No. 1272/2008.
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