Propanoic acid, 2-hydroxy-, C12-13-branched alkyl esters

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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 study available

Additional information

Skin irritation

The skin irritation potential of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters was investigated in a GLP-conform study conducted according to OECD guideline 404 (Biffi, 1992). The solid test material (0.5 g) was mixed with 0.5 mL sesame seed oil and applied to the shaved skin of 6 male rabbits for an exposure period of 4 h under occlusive conditions. Skin effects were evaluated at 1, 24, 48 and 72 h after patch removal. At the 1 h reading time point, 2/6 rabbits showed very slight erythema, which persisted up to 24 h and 48 h after patch removal in the affected animals, respectively. However, all observed skin irritation effects were completely reversible within 72 hours. No edema was observed at any reading time point and no local or systemic effects were noted. Therefore, the substance was considered to be not irritating to the skin.

Furthermore, a human patch test is available investigating the skin irritation potential of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters in 30 volunteers (Celleno, 1992). Nine male and 21 females were epicutaneously (intact back skin) exposed to 0.5 mL of the unchanged test substance for an exposure period of 48 h under occlusive conditions. Skin reactions were observed 15 min and 12 h after patch removal. No erythema or edema was observed in any of the subjects at any reading time point, indicating that the test material was not irritating to human skin under the conditions of this study.

Eye irritation

The eye irritation potential of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters was investigated in a study performed similar to OECD guideline 405 (Biffi, 1993). The undiluted test material (0.1 mL) was placed into the conjunctival sac of one eye of 6 male New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Very slight redness (conjunctivae) was observed in 3/6 animals at the 1 h reading time point, which was fully reversible within 24 hours. No corneal or iridial effects were noted at any observation time point during the study. No further local or systemic toxic effects were observed. The mean cornea, iris, conjunctivae and chemosis scores after 24, 48, and 72 h were 0 for all 6 animals. Based on these results, the test substance is not considered to be an eye irritant.

Conclusions for irritation / corrosion

Based on the available data on skin irritation in humans and rabbits, Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters is not considered to be skin irritating.

Furthermore, the results of an eye irritation study in rabbits do not indicate an eye irritation potential of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters.

Justification for selection of skin irritation / corrosion endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
There is only one study available.

Justification for classification or non-classification

The available data on the skin and eye irritation potential of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

There are no data available on respiratory irritation.