Registration Dossier
Registration Dossier
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EC number: 203-113-5 | CAS number: 103-45-7
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 evidence of skin sensitisation was seen with phenyl ethyl acetate, either in the Freund's Complete Adjuvant Test (FCAT: an adjuvant method) or in the Open Epicutaneous Test (OET: a non-adjuvant method). Although the studies are of non-standard design, the constently negative results are considered to be sufficient to conclude an absence of sensitising potential . The results of the two guinea pig assays are also consistent with the results of human testing. Following induction and challenge of 25 male volunteers with hexyl acetate, using a version of the repeat insult patch test, no reactions were apparent in any of the 25 volunteers challenged with hexyl acetate. No evidence of delayed contact hypersensitivity was seen in this human patch test. It is considered unlikely that phenyl ethyl acetate would elicit contact sensitisation in humans in normal use.
Migrated from Short description of key information:
Complementary testing of phenyl ethyl acetate in two guinea pig models, one with and one without adjuvant, confirmed the absence of sensitising potential determined in a human repeat insult test.
Justification for selection of skin sensitisation endpoint:
Only one study is available for this endpoint
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Justification for selection of respiratory sensitisation endpoint:
No data requirement at this tonnage band
Justification for classification or non-classification
Negative responses obtained in animal studies and human volunteer investigations indicating there is no sensitising potential for phenylethyl acetate. No classification warranted based on the Open Epicutaneous Test findings.
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