Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
No studies are available on dibutyl esters, but a skin- and an eye irritation study are available for the isobutyl esters, along with skin- and eye irritation studies for the dibutyl adipate.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin:
In a well conducted skin irritation study using the isobutyl esters this substance failed to produce signs of irritation. Given the similar results in the older, non-standard guideline studies available for dibutyl adipate where individual and repeated dermal exposures were used it is concluded that the dibutyl esters would not be irritating to the skin.
Eye:
In a well conducted eye irritation study using diisobutyl esters this substance produced some minimal signs of irritation but they did not persist nor were they sufficient for classification. Given the similar results in the older, non-standard guideline studies available for dibutyl adipate it is concluded that the dibutyl esters would not be irritating to the eyes.
Respiratory:
No data are available for this substance. Data on the available read across substances (dimethyl esters) indicate that there are some signs of histopathological signs of local irritation in the upper respiratory tract in animals dosed via the inhalation route. There were no changes in breathing pattern associated with these changes. This substance also has a higher vapour pressure than the dibutyl esters and so potential for inhalation exposure leading to irritation is far lower with the dibutyl esters compared to the methyl esters. There are also no evidence in humans of respiratory irritation when handling this material. Therefore this substance is not considered to be a respiratory irritant.
Justification for classification or non-classification
Criteria for classification not met. Therefore, no classification required.
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