Registration Dossier
Registration Dossier
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EC number: 203-686-1 | CAS number: 109-60-4
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 data from animal studies were available for Propyl Acetate.
The sensitizing potential of propyl acetate was evaluated using OASIS TIMES MIX V.2.25.7, OASIS TIMES MIX V.2.27.17 and the OECD QSAR toolbox.
The QSAR programs came to the conclusion that propyl acetate is not a skin sensitizer. A human maximization test with volunteers (Kligman, 1978), where propyl acetate was investigated for skin sensitization, led to a negative result as no local effects where observed upon challenge exposure. Propyl acetate was thus not a skin sensitizer in this human maximization test.
The analogous substance butyl acetate, CAS No. 123-86-4, was tested negatively in a guinea pig maximisation test and a mouse ear swelling test as 0/15 and 0/10 animals, respectively, showed no positive reactions (Gad et al. 1986).
In addition, propanol is also considered not to be a skin sensitizer based on available data (ECHA dessiminated dossier).
Read across justification to propan-1-ol and n-butyl acetate for filling data gaps of n-propyl acetate:
Skin sensitisation studies are available performed with the read-across substance n-butyl acetate as well as propyl acetate (Human data and QSAR). Read-across is applied using these studies with n-butyl acetate in addition as an adaptation to the requirements of Annex VII, section 8.3 of the REACH Regulation. The standard information requirements are considered to be fulfilled, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
As indicated by toxicokinetic studies (see chapter on toxicokinetics, metabolism and distribution), n-propyl acetate is rapidly hydrolyzed to propan-1-ol and acetate (acetic acid). Available data on propan-1-ol is therefore suitable for filling data gaps of n-propyl acetate.
N-propyl acetate and n-butyl acetate differ structurally by only one –CH2 group and both substances have a similar toxicological profile. The available data for n-butyl acetate is therefore suitable for filling the data gaps of n-propyl acetate due to structural similarities.
For a detailed justification of read-across, please refer to IUCLID section 13.
Migrated from Short description of key information:
Propyl acetate
Human data: not a skin sensitizer
QSAR: not a skin sensitizer
Butyl acetate (CAS No. 123-86-4)
Guinea Pig Maximisation Test: negative (Gad et al. 1986)
Mouse Ear Swelling Test: negative (Gad et al. 1986)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No indications were given for a skin sensitisation potential of propyl acetate.
Migrated from Short description of key information:
No data available
Justification for classification or non-classification
Based on the overall available data, there is no need for classification of propyl acetate as skin sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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