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 on the skin sensitisation potential of Fatty acids, soya, 2 -ethylhexyl esters (CAS# 93572 -14 -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 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,

the substance listed below are selected as reference substances for hazard assessment.

Overview of skin sensitisation

CAS

Skin sensitisation

93572 -14 -6 Target substance

RA: 135800-37-2

RA: 91031-48-0

135800-37-2

Not sensitising

91031-48-0

Not sensitising

The above mentioned substance is 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, soya, 2-ethylhexyl esters (CAS 93572-14-6).

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

Discussion:

CAS 91031 -48 -0

Fatty acids, C16-18, 2-ethylhexyl esters (CAS# 91031-48-0) was tested for its skin sensitisation potential in a Guinea pig maximization test according to OECD Guideline 406 (Clouzeau, 1991). 20 test and 10 control animals (Dunkin-Hartley guinea pigs) were induced intradermally with the test substance diluted to 25% in paraffin oil. 7 days later the epidermal induction was performed with the undiluted test substance, as this concentration (100%) was found to be slightly irritating in the range finding test. 12 days after the last induction treatment the animals were challenged with a 50 % test substance solution in paraffin oil. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications for a skin sensitising potential of the test substance.

 

CAS 135800 -37 -2

A Guinea pig maximisation test was performed with Fatty acids, C8-16, 2-ethylhexyl esters (CAS# 135800-37-2) according to OECD Guideline 406 (Steiling, 1991). 19 test and 10 control animals (Dunkin-Hartley guinea pigs) were induced intradermally with 5% test substance (100% pure) diluted in peanut oil on both sides of the spine with and without Freud's complete adjuvant. 7 days later a 40% test substance dilution was used for the epidermal induction for 48 hours. Another 14 days later the animals were challenged by epidermal induction of the sheared flank skin with test substance diluted to 20% with paraffin oil. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications for a skin sensitising potential of the test substance.

Conclusion for skin sensitisation

Two GPMT have been conducted with the structure related substances Fatty acids, C16-18, 2-ethylhexyl esters (CAS# 91031-48-0) and Fatty acids, C8-16, 2-ethylhexyl esters (CAS# 135800-37-2). There is no evidence for a skin sensitising potential in any of these studies. Thus, Fatty acids, soya, 2 -ethylhexylesters is not considered to be a skin sensitizer.


Migrated from Short description of key information:
Based on a weight of evidence approach, Fatty acids, soya, 2-ethylhexyl esters has no sensitsing potential.

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 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.