Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: not irritating (OECD 404, GLP, analogue approach)
Eye irritation: not irritating (OECD 405, GLP, analogue approach)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for grouping of substances and read-across

There are no data available for the skin and eye irritation potential of Fatty acids, soya, 2 -ethylhexyl esters (CAS 93572-14-6). In order to fulfil the standard information requirements set out in Annex IX, 8.7, 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,

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

Overview for Skin and Eye irritation

CAS

Skin Irritation/Corrosion

Eye Irritation/Corrosion

93572-14-6 Target substance

RA: 26399-02-0

RA: 29806-73-3

RA: 22047-49-0

RA: 91031-48-0

RA: 290806-73-3

26399-02-0

Not irritating

--

29806-73-3

Not irritating

Not irritating

2204749-0

Not irritating

--

91031-48-0

--

Not irritating

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).

Skin irritation:

CAS 29806-73-3

Three studies performed with 2-Ethylhexyl Palmitate (CAS 29806-73-3) to assess the skin irritating potential are available. An acute dermal irritation test was performed according to OECD Guideline 404 under GLP conditions (Guest, 1990). The shaved skin of three New Zealand White rabbits was exposed to 0.5 mL of the unchanged test substance (no data on purity) for 4 hours under semi-occlusive conditions. Then, the test substance was gently wiped off with cotton wool soaked in diethyl ether. The treated skin sites were examined according to the Draize scoring system 24, 48 and 72 hours after application. Only very slight erythema (mean scores = 0.67, 0.33, and 0.67) occurred, which were fully reversible within 48 to 72 hours.

CAS 22047-49-0

One acute dermal irritation study performed similar to OECD Guideline 404 to evaluate the skin irritation potential of 2-Ethylhexyl Stearate (CAS 22047-49-0) is available (Masson, 1985). Six New Zealand rabbits were treated with 0.5 mL of the unchanged test substance (no data on purity) for 24 h under occlusive conditions. The animals were observed for 72 hours and scoring according to Draize was performed 24 and 72 h after application. Slight to moderate erythema was observed in all animals (mean scores = 1.33, 1.67, 2.0, 0.67, 0.67, and 2.0) and slight oedema formation (mean score = 0.33) was only seen in one animal. The mean values were calculated assuming the 48-h reading to be the same as the 24-h reading. 3/6 animals were without any effects 72 h after application whereas in the remaining three rabbits the signs for irritation were still present. As the effects were slight and the deviations from the current guideline might lead to an overestimation of the effects (24 h instead of 4 h treatment, occlusive instead of semi-occlusive), reversibility within an adequate observation period up to 14 days is assumed. Therefore, the test substance is not considered irritating to the skin.

CAS 26399-02-0

The skin irritation/corrosion potential of 2-Ethylhexyl Oleate (CAS 26399-02-0) was tested in a primary dermal irritation study according to OECD Guideline 404 (Dufour, 1991). The skin of three New Zealand White rabbits was exposed to 0.5 mL unchanged test material (no data on purity) for 4 hours under occlusive conditions. The rabbits were observed for 72 hours. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48 and 72 hours after removal of the test substance. The exposure period of 4 hours caused only very slight oedema and erythema in one rabbit (mean scores = 0.33, respectively). All treated skin sites appeared normal at the 48 hour observation. Therefore, the test substance is not considered irritating.

Eye irritation:

CAS 29806-73-3

Four studies are available to evaluate the eye irritation potential of 2-Ethylhexyl Palmitate (CAS 29806-73-3).

An acute eye irritation study was performed according to OECD Guideline 405 under GLP conditions (Guest, 1990). 0.1 mL of the unchanged test substance (no data on purity) was instilled to the right eye of three New Zealand White rabbits. The untreated left eye served as control. Examination of the treated eyes 24, 48 and 72 hours after instillation revealed no ocular changes.

In a second study performed according to a protocol similar to OECD Guideline 405, 0.1 mL of the test substance (no data on purity) was instilled in one eye of six New Zealand White rabbits (Sugar, 1980). The animals were observed for 72 hours and scoring according to Draize was performed 24, 48, and 72 hours after instillation. Slight effects were observed on conjunctivae (redness and swelling) and in one animal on iris (grade 1 at 24 h). The mean scores (24, 48, and 72 h) for conjunctivae redness were 0.67, 0.67, 0.33, 0.67, 1.0, and 1.33 and for conjunctivae swelling 0.33, 0.33, 0.67, 0.67, 0.33, and 0.33. All effects were fully reversible within 72 h except in one animal (conjunctivae redness grade 1 at 72 h). However, full reversibility in case of a prolonged and thus adequate observation period is assumed. Therefore, the test substance is not considered eye irritating in this study.

CAS 91031-48-0

Fatty acids, C16-18, 2-Ethylhexyl Esters (CAS 91031-48-0) was examined for its eye irritation potential in a study performed equivalent to OECD Guideline 405 (Potokar, 1978). 0.05 mL undiluted test substance (no data on purity) was instilled into the right eye of 2 rabbits. 2, 6 and 24 hours after instillation examination of the treated eyes revealed no ocular lesions. Thus, based on the study results, the test substance showed no eye irritating potential.

Conclusion for skin and eye irritation

There are three skin irritation studies available with the structure related substances 2-Ethylhexyl Palmitate (CAS 29806-73-3), 2-Ethylhexyl Stearate (CAS 22047-49-0) and 2-Ethylhexyl Oleate (CAS 26399-02-0). All studies revealed no indication for skin irritation.

Eye irritation potential has been investigated based on an analogue read-across approach with 2-Ethylhexyl Palmitate (CAS 29806-73-3) and Fatty acids, C16-18, 2-Ethylhexyl Esters (CAS 91031-48-0) in in vivo assays, respectively. There was no indication of eye irritating potential.

Therefore, Fatty acids, soya, 2-ethylhexyl esters is not considered to be skin or eye irritating.


Justification for selection of skin irritation / corrosion 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).

Justification for selection of eye irritation 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).

Justification for classification or non-classification

Based on read-across from the structurally similar substances, the available data for skin and eye irritation 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.