Isooctadecyl isooctadecanoate

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 the registered substance was investigated in a GLP compliant study conducted according to OECD TG 404 (Saboureau, D., 1989). 0.5 mL of the undiluted test substance was applied to the shaved skin of 3 rabbits and covered with a semi-occlusive dressing for 4 hours. The test substance caused very slight erythema in 3/3 rabbits at both the 1 h and 24 h reading time points; the effect persisted in 2/3 rabbits until 72 h after exposure ended. 1/3 animals had a very slight edema at the 1 h reading time point. All skin irritation effects were completely reversible within 5 days post-exposure. A further supporting skin irritation study performed according to a protocol similar to OCED TG 404 is also available ( Saboureau, 1991). In this study, 0.5 mL of the undiluted test substance was applied to the skin of 3 rabbits and covered with an occlusive dressing for 24 hours. The test substance caused a very slight erythema (grade 1) in 1/3 animals at both the 1 h and 24 h reading time points, but was fully reversed within 72 h post-exposure.

 

Eye irritation

The eye irritation potential of the registered substance was investigated in a GLP compliant study performed according to OECD TG 405 (Saboureau, D., 1989). 0.1 mL of the undiluted test material was placed into the conjunctival sac of one eye of 3 New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were examined and scored at 1, 24, 48 and 72 h after application. A slight redness (conjunctivae) was observed in 1/3 animals at the 24 h reading time point, which was fully reversible within 48 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, and chemosis scores after 24, 48, and 72 h were 0 for all 3 animals. The mean conjunctivae score after 24, 48 and 72 h of one animal was 0.33; however the other two was 0. 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 on rabbits, the registered substance 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 the registered substance.

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 the registered substance 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.