Registration Dossier
Registration Dossier
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EC number: 224-644-9 | CAS number: 4435-53-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
No in vivo tests are available for 3-methoxybutyl acetate, however information is presented below from structural alert considerations, results of in vivo sensitisation tests on structurally similar substances and information on putative metabolic products.
Structural alerts
With its simple alkyl backbone, lack of functionality to allow binding to protein, there is no obvious structural alert for sensitisation with 3 -methoxybutyl acetate or its major metabolite, 3 -methoxybutan-1-ol (Ashby et. al., 1995; OECD, 2009).
Similar chemistry
n-butyl acetate has been tested in vivo and reported to be negative (Gad et al., 1986).
Metabolic considerations
The putative rapidly and extensively formed proximate metabolic products of 3 -methoxybutyl acetate are 3-methoxybutan-1-ol and acetate. Each putative metabolite is considered separately.
3-methoxybutan-1-ol (metabolite). No in vivo tests are available for 3-methoxybutan-1-ol. However the close structural analogue 3-methoxy-3-methyl-1-butanol, differing only by a single methyl group, has been tested in vivo and negative results reported for sensitisation (OECD, 2004).
Acetate
Acetic acid is present at physiological pH as acetate and is a key biochemical intermediate in all living organisms. There are no reports of sensitisation from the available literature, nor would any be expected for this fundamental biochemical intermediate of mammals (EU DAR, 2008)..
For 3-methoxybutyl acetate and its putative, rapidly and extensively formed metabolites, consideration of structural alerts, QSAR analysis, results of in vivo sensitisation assays for similar chemistry reveal enough evidence to conclude that 3-methoxybutyl acetate is devoid of dermal sensitising potential. Inhalation studies in rats, mice dogs and cats have not highlighted respiratory sensitisation for 3-methoxybutyl acetate or 3 -methoxybutan-1 -ol.
Citations
Dupuis, G. and Benezra, C. (1982) Allergic Contact Dermatitis to Simple Chemicals. Marcel Dekker, New York and Basel. (cited by Ashby et al., 1995)
European Union Draft Risk Assessment (2008) Initial risk assessment provided by the rapporteur Member State Germany for the existing active substance Acetic acid of the fourth stage of the review programme referred to in Article 8(2) of Council Directive 91/414/EEC.
Landsteiner, K. and Jacobs, J.L. (1936) Studies on the sensitization of animals with simple chemical compounds III. J. Exp. Med. 64.625-639. (cited by Ashby et al., 1995)
OECD (2004): SIDS for 3-Methoxy-3-methyl-1- butanol, Paris, France, 20-23 April 2004
Migrated from Short description of key information:
The weight of evidence indicates that 3-methoxybutyl acetate is devoid of dermal sensitising potential.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
There is no evidence from inhalation studies in rats, mice dogs and cats that 3-methoxybutyl acetate causes respiratory sensitisation.
Justification for classification or non-classification
According to criteria in Regulation (EC) No.1272/2008, the substance is not classified for skin or respiratory tract sensitisation. There is no evidence of sensitising potential for 3 -methoxybutyl acetate.
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