Registration Dossier
Registration Dossier
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EC number: 500-214-9 | CAS number: 68440-06-2
Endpoint summary
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 only limited data available on skin sensitization of Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). 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 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 sensitization:
CAS
Chemical name
Molecular weight [g/mol]
Skin sensitization
68440-06-2 (a)
Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters
789
RA: CAS 68334-05-4
68334-05-4 (b)
Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters
673
Experimental result: not sensitizing
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
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 for Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Skin sensitization
CAS 68334 -05 -4
No data on skin sensitization is available with Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). Therefore, read across from the structural analogue substance Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters (CAS 68334-05-4) was applied. The skin sensitizing properties of Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters (CAS 68334-05-4) were tested in a study according to OECD TG 429 and in compliance with GLP (Stitzinger, 2010) using the local lymph node assay (LLNA). In this study groups of five female CBA/J mice were treated with the test item at concentrations of 25, 50 and 100% (w/w) in acetone/olive oil (4:1 v/v). Topical application of 25 µL of the appropriate test substance concentrations was performed daily at the dorsal surface of each ear for three consecutive days. Five days following the first topical application of the test item or vehicle all mice were injected via the tail vain with 250 µL PBS containing 3H-methylthymidine (20 µCi per mouse). Five hours after injection single cell suspension of pooled lymph nodes was prepared for each animal, followed by determination of 3HTdR incorporation. Positive and negative controls were included in the study and gave the expected results. The calculated stimulation indices (SI) of the test substance are 1.6, 1.6 and 2.5 at concentrations of 25, 50 and 100% (w/w), respectively and therefore < 3. Thus, under the conditions of the test, the test substance revealed no skin sensitizing properties.
Migrated from Short description of key information:
Skin sensitization (OECD 429): not sensitizing (RA CAS 68334-05-4)
Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues/surrogates. 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.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitization of Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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