Hexanedioic acid, di-C16-18 (even numbered) alkyl esters

Endpoint summary

Description of key information

Skin irritation (OECD 404), rabbit: not irritating
Eye irritation (Federal Hazardous Substances Act Regulations (16 CFR 1500.42)), rabbit: 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

Justification for grouping of substances and read-across

There are no data available on the skin and eye irritation of Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters (CAS 92969-90-9). In order to fulfil the standard information requirements set out in Annex VII and VIII, 8.1. and 8.2., in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across). Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural

 

Skin irritation

CAS 16958-92-2

Bis(tridecyl) adipate was tested for its skin irritation potential in New Zealand White (Hsdlf:NZW) rabbits according to OECD TG 404 and in compliance with GLP (key, 2012).The test substance was applied to the clipped skin of the back of 1 male and 1 female rabbit using a semi-occlusive dressing. After an exposure period of 4 h, the test substance was removed and scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. Very slight erythema (grade 1) was noted in 1 animal at the 24 h reading time point, which was fully reversible within 48 h after treatment. No further skin reactions (erythema and edema) were observed in both animals. The mean erythema and edema scores after 24, 48 and 72 h were 0.33 and 0 in one animal. In the other animal, the mean erythema and edema scores after 24, 48 and 72 h were 0, respectively. Therefore, Bis(tridecyl) adipate is not considered to be irritating to the skin.

 

Eye irritation

CAS 16958-92-2

The eye irritation potential of Bis(tridecyl) adipate was assessed according to the Federal Hazardous Substances Act Regulations (16 CFR 1500.42) (key, 1973). The undiluted test substance was placed into the conjunctival sac of one eye in each of 6 rabbits. The other eye remained untreated and served as control. The eyes were examined and scored for irritating effects 24, 48 and 72 h after instillation. No corneal, iridial or conjunctival effects were noted in the animals at any of the reading time points. 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, respectively. Therefore, Bis(tridecyl) adipate is not considered to be irritating to eyes.

 

Conclusion for skin and eye irritation

In conclusion, as the reliable data available for the analogue substance Bis(tridecyl) adipate do not indicate skin and eye irritating properties, Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters is not expected to be irritating to the skin and the eyes.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Hexanedioic acid, di-C16-18 (even numbered)-alkyl esters, data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

 

Therefore, based on the analogue read-across approach, the available data on irritation/corrosion do not meet the classification criteria accordingto Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.