Registration Dossier

Administrative data

Description of key information

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 data available for the skin sensitisation potential of Fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6). In order to fulfil the standard information requirements set out in Annex VII, 8.3 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 put 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 similarity, the substance listed below are selected as reference substances for hazard assessment.

Overview of skin sensitisation

CAS

Skin sensitisation

94581-09-6

Target substance

RA: CAS 68002-79-9

RA: CAS 403507-18-6

68002-79-9

not sensitising

403507-18-6

not sensitising

The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

CAS 68002-79-9

A Buehler test was performed with Fatty acids, C16-18 (even numbered) and C16-18 unsatd. (even numbered), triesters with trimethylolpropane (CAS 68002-79-9) according to OECD Guideline 406 (Pittermann, 1994) and under GLP conditions. 20 female Pirbright white guinea pigs were treated with the test substance and compared with 10 negative female control animals. Data for a positive control substance are not reported. A range finding test was conducted for dose selection. Three epidermal inductions were performed with 100% test substance in weekly intervals for 6 hours under occlusive conditions. 14 days after the last induction treatment, all animals were challenged for 6 hours epicutaneously with 100% test under occlusive conditions. Animals were evaluated for skin reactions 24, 48 and 72 h after challenge. In the test group, no reactions were seen at the first reading time point, while at the second and third reading time point 5 and 1 animal showed a slight skin erythema on the right flank, respectively. Slight dermal effects on the right flank were seen in one animal of the control group at the first and second reading. Thus, the test substance was found not to be skin sensitizing.

CAS 403507-18-6

The skin sensitisation potential of Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) was evaluated in guinea pigs with a Guinea pig maximisation test for skin sensitisation performed according to OECD 406 under GLP conditions (Sanders, 2002). 10 male Dunkin-Hartley guinea pigs were treated with the test substance and compared to 5 male control animals. A 5% dilution of the test substance in arachis oil was used for intradermal induction in the shoulder region on Day 0. 100% of the test item was used for topical induction in the shoulder region on Day 7. 21 days after the last induction treatment, all animals were challenged epicutaneously with the undiluted and 75% test substance. 48 and 72 hours after challenge, none of the test animals showed any skin reaction. Thus, the test substance is not considered to have skin sensitizing potential.


Migrated from Short description of key information:
Skin sensitisation: not sensitising (OECD 406, analogue approach)

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available data on skin sensitisation of structurally related substances 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.