Registration Dossier
Registration Dossier
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EC number: 204-662-3 | CAS number: 123-92-2
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
7.4.1.003 (key data): Study equivalent or similar to OECD TG 406; test substance: Primary Amyl Acetate (mixture of n-pentyl acetate and 2-methylbutyl acetate)
Results:
- 1st reading, 24 h after challenge, dose level 100 %, no. of animals with reactions was 1 of 20.
- 2nd reading, 48 h after challenge, dose level 100 %, no. of animals with reactions was 0 of 20.
Conclusion: little or no potential to produce dermal sensitization in guinea pigs, hence the substance does not meet the EU criteria for classification.
Respiratory sensitisation:
There is no scientific data available about the respiratory sensitisation of isopentyl acetate.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The result of the key study (under 7.4.1.003) is regarded as meaningful to evaluate the potential of isopentyl acetate for skin sensitisation due to the molecular similarity of n-pentyl acetate and 2 -methylbutyl acetate to isopentyl acetate (they are all structrual isomers). Structural similarity is regarded as particular relevant for the local effect on the skin. The similarities are described as follows: same molecular weight, one ester group, all esters of acetic acid, only variation in the form of the pentyl residue wheras 2-methylbutyl acetate exhibits the closest similarity to isopentyl acetate as it also has a branched pentyl residue.
It is therefore assumed that isopentyl acetate would give equal or similar effects as the test substance.
Based on the results of the study there is little or no potential to produce dermal sensitization in guinea pigs, not meeting the EU criteria for classification.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No skin sensitisation was observed in a OECD TG 406 study. No data about respiratory sensitisation has been located.
According to Annex I in Regulation (EC) No 1272/2008 of the European Parliament and of the Council, pages L353/1081 and L353/547, isopentyl acetate is not classified as sensitising to the skin or the respiratory system.
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