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 sensitisation potential of Fatty acids, C8-10, octyl esters (CAS 91031-98-0). In order to fulfil the standard information requirements set out in Regulation (EC) No 1907/2006, Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, a 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 similarity.

Overview of skin sensitisation

CAS#

Skin Sensitisation

91031-98-0 Target substance

RA: 135800-37-2

RA: 34316-64-8

135800-37-2

Not sensitising

34316-64-8

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, C8-10, octyl esters (CAS 91031-98-0).

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

CAS 135800-37-2

A Guinea pig maximisation test was performed with 2-ethyl-hexylester with Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) according to OECD Guideline 406 (Steiling, 1991). A range-finding study was performed for dose selection. In the main study, 20 female Pirbright-White guinea pigs were treated with the test substance at 0.5% for intradermal and 40% for epidermal induction on Days 1 and 7, respectively. 10 animals served as negative controls. A positive control group was not included in the study and no information is given on periodical testing of strain sensitivity, either. One animal of the test group died after the first induction. 14 days after the epidermal induction, epidermal challenging was performed with a 20% test material dilution in paraffin oil. 24 and 48 hours after challenging skin reactions were examined. One animal of the test group and five animals of the control groups showed skin reactions (grade 1) 24 hours after challenging. 48 h after challenging one animal of the control group still showed skin reactions (grade 1). Thus, the test material was found to be not sensitising to the skin of guinea pigs under the test conditions chosen.

CAS 34316-64-8

A Magnusson-Kligman test was performed with 2-dodecanoic acid, hexyl ester (CAS 34316-64-8) similar to OECD Guideline 406 (Gloxhuber, 1978). A range-finding study was not performed for dose selection. 20 female Pirbright-Hartley guinea pigs were treated with the test substance at 1% (in vaseline) for epidermal challenging. No further information on induction is available. 24 hours after challenging skin reactions were examined. No individual data were given. However, the experimental and control animals reacted to the retreatment qualitatively identical with perceivable reddening of the parts of the skin treated, this quickly subsided and 24 hours after removal of the patch no further reaction was visible. Similar observations are reported when vaseline is used as vehicle for retreatment. Thus, the test material was found to be not sensitising to the skin of guinea pigs under the test conditions chosen.

 

Conclusion:

A GPMT and a Magnusson-Kligman test have been conducted with the structurally related substances Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) and 2-dodecanoic acid, hexyl ester (CAS 34316-64-8), respectively. There is no evidence for a skin sensitising potential.


Migrated from Short description of key information:
The overall assessment of the available information gave no indication for sensitising properties of the structural analogues.

Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. All 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:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

Based on read-across from the structurally similar substances, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.