Triisononanoic acid, triester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)propane-1,3-diol] tris(2-ethylhexanoate)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Justification for grouping of substances and read-across

There are no reliable data available for the sensitising properties ofDiPE triisononanoate triethylhexanoate(CAS 68443-84-5). In order to fulfil the standard information requirements set out in Annex IX, 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 health, 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, 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 similarity.

Sensitisation

CAS	68443-84-5	---
Chemical name	DiPE triisononanoate triethylhexanoate	Pentaerythritol C7-C10 Tetraester
MW	1053.6 – 1081.59 g/mol	584.8 – 753.1 g/mol
Skin sensitisation	RA: Pentaerythritol C7-C10 Tetraester	Experimental result: not sensitising

 

The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints forDiPE triisononanoate triethylhexanoate(CAS 68443-84-5).

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Discussion

Skin sensitisation

The sensitisation potential is evaluated using data from a Buehler test performed equivalent to OECD guideline 406 with the structural analogue Pentaerythritol C7-C10 Tetraester (Lees, 1991). Twenty male Albino guinea pigs received three epicutanous applications of the pure test substance for 6 h each under occlusive conditions with a 7 day interval between the applications. After a rest period of 14 days after the last induction, the challenge was performed by applications of 30% and 100% substance for 6 h. The skin sites were evaluated 24 and 48 h later and scored for erythema and edema, respectively. A group of ten animals was used as controls, only receiving the challenge applications. Since none of the twenty test animals showed any signs of skin reaction, the test substance was not sensitising to the skin under the experimental conditions applied.

In conclusion, the available data on the analogue substances indicate that DiPE triisononanoate triethylhexanoate is not a skin sensitiser.

 

Migrated from Short description of key information:
Skin sensitisation:
OECD 406 (Buehler test), RL2 (Lees, 1991): not sensitising

Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The available data on skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.