Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol

Endpoint summary

Description of key information

Skin irritation (OECD 404, GLP): not irritating (RA CAS 147256-33-5 and CAS 68334-05-4)

Eye irritation (OECD 405, GLP): not irritating (RA CAS 147256-33-5 and CAS 68334-05-4)

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

Justification for read-across

There are no data on skin irritation/corrosion and eye irritation available for Fatty acids, C18-unsatd., dimers, polyers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2). Thus, read-across from appropriate substances are conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Information will be taken into account from the analogue substances Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) and Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.1 and 8.2. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

 

Skin irritation/corrosion

CAS 147256-33-5

The skin irritancy potential of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) was determined in a skin irritation study performed according to OECD 404 and in compliance with GLP (Harlan Laboratories, 2012). The test substance was topically applied to the clipped skin of three male rabbits (NZW) for 4 h. Local reactions were scored at 1, 24, 48 and 72 h after substance application. Very slight erythema (grade 1) was noted at one treated skin site at the 24 and 48 h reading time points that was fully reversible within 72 h. Based on the results of the conducted study, the test substance did not exhibit irritating properties towards the skin.

 

CAS 68334-05-4

The skin irritancy potential of Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) was determined in a skin irritation study performed according to OECD 404 and in compliance with GLP (Notox B.V., 2010). The test substance was topically applied to the clipped skin of three male rabbits (NZW) for 4 h. Local reactions were scored at 1, 24, 48 and 72 h after substance application. Very slight erythema (fully reversible within 48 h) and very slight edema (fully reversible within 24 h) in the treated skin areas of the three rabbits were noted. The skin irritation resolved within 48 hours after exposure in all animals. There was no evidence of a corrosive effect on the skin. Based on the results of the conducted study, the test substance did not exhibit irritating properties towards the skin.

 

In conclusion, based on the analogue approach, Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) is not considered to exhibit skin irritating properties.

 

Eye irritation

CAS 147256-33-5

To evaluate the irritation potential towards the eyes, 0.1 mL Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (undiluted) was instilled into the eyes of 3 white rabbits (NZW) according OECD TG 405 and in compliance with GLP (Harlan Laboratories, 2012). 24 h after test substance instillation, the eyes were rinsed with water. The eyes were observed 1, 24, 48 and 72 h after treatment. No corneal or iridial effects were noted during the study. Minimal conjunctival irritation (grade 1) was noted in all treated eyes 1 and 24 h after test substance instillation, that were fully reversible within 48 h. Based on the results of the conducted study, the test substance is considered as not irritating to the eyes.

 

CAS 68334-05-4

An acute eye irritation study with Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) was performed according to OECD guideline 405 and under GLP conditions with 3 male New Zealand White rabbits (Notox B.V., 2010). One eye of the rabbits was exposed to 0.1 mL of the undiluted test substance and scored for eye reactions. The untreated eye served as control. The animals were observed for 72 h and scoring was performed 1, 24, 48 and 72 h after application. Irritation of the conjunctivae, which consisted of redness and discharge was observed in all rabbits. The irritation completely resolved within 48 hours in all animals. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. There was no evidence of ocular corrosion. Based on these results the test substance is not regarded as eye irritant.

 

In conclusion, based on the analogue approach, Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) is not considered to exhibit eye irritating properties.

Justification for classification or non-classification

Based on the analogue approach, 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.