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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin, rabbit (OECD 404): not irritating
Eye, rabbit (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

In summary, two reliable studies assessing the skin and eye irritation potential of isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester (CAS 109884-54-0) are available.

Skin irritation

CAS 109884-54-0

In a key skin irritation study performed according to OECD TG 404 and in compliance with GLP three male New Zealand White rabbits were exposed to 0.5 mL of the neat test material for 4 hours applied onto the clipped skin via semi-occlusive dressing (Latour, 2014b). Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. The dermal application of the test substance did not result in erythema or edema in any of the animals tested at any observation time point. No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

 

Eye irritation

CAS 109884-54-0

A key eye irritation study performed according to OECD TG 405 and in compliance with GLP with isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester (CAS 109884-54-0) is available (Latour, 2014c). For the assessment of the eye irritation properties 0.1 mL of the test substance was instilled in the eye of three male New Zealand White rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. Instillation of 0.1 mL of test substance into one eye of each of three rabbits resulted in slight irritation of the conjunctivae, which consisted of redness in all animals and discharge in one animal. The irritation had completely resolved within 24 hours in all animals. Neither iridial irritation nor corneal opacity and chemosis were observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Conclusion for skin and eye irritation

In conclusion, two reliable skin and eye irritation studies are available for the target substance indicating that isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester is not considered to be skin irritant or an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
The reliable GLP compliant OECD Guideline study was choosen.

Justification for selection of eye irritation endpoint:
The reliable GLP compliant OECD Guideline study was choosen.

Justification for classification or non-classification

The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.