Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: not irritating (OECD 404)
Eye irritation: not irritating (OECD 405)

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

Skin irritation

Two studies investigating the skin irritation properties of 2-ethylhexyl benzoate are available.

The key study was conducted according to OECD guideline 404 under GLP conditions (Blanchard, 2000). A group of three New Zealand White rabbits was treated with 0.5 mL of the undiluted test substance for 4 h onto the shaved skin. Skin reactions were evaluated 20 min, 16, 43 and 72 h after patch removal and subsequently daily until Day 14.

Very slight to well defined erythema was seen in all animals (mean out of all 3 animals over 16, 43 and 72 h: 0.67). In addition, thickening of the skin was observed in two animals. Reactions gradually reversed and had resolved completely in two animals by Day 8 or Day 13, respectively. However, very slight erythema was still evident in one animal at Day 14. No signs of toxicity or ill health were observed in any animal during the study period.

Furthermore, in the supporting study, 2-ethylhexyl benzoate was tested similar to OECD guideline 404 in compliance with GLP (Johnson, 2001). In the study, three rabbits were exposed to 0.5 mL of the undiluted test substance, applied onto the shaved skin for 4 h. The treated skin was observed and evaluated at 30-60 min and 24, 48 and 72 h post-application. No erythema or edema formation was noted in the test animals during the study period. No further local or systemic effects were observed.

In addition, a study on the acute dermal toxicity of 2-ethylhexyl benzoate is available according to OECD guideline 403 in compliance with GLP (Blanchard, 2000). In this study, transient very slight dermal irritation (Grade 1 erythema with or without Grade 1 oedema) was seen in all animals after an occlusive 24 h exposure being fully reversible by Day 4.

In summary, under the conditions described, no evidence of skin irritation properties was seen after treatment with 2-ethylhexyl benzoate.

Eye irritation

In a key study, the eye irritation properties of 2 -ethylhexyl benzoate were tested according to OECD guideline 405 in compliance with GLP (Blanchard, 2000).

In a group of three male New Zealand White rabbits, 0.1 mL of the undiluted test substance was applied into one eye. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h after application.

No effects on cornea and iris were observed during the study period in any animal. Slight conjunctival redness was observed in all animals 1 h after instillation. In 1/3 animals the redness was still apparent at the 24 h reading and was fully reversible within 48 h (mean score over 24, 48 and 72 h animal #1 = 0.33). No chemosis was observed during the study period in any animal. No further local or systemic effects were observed in any animal during the study period.

Under the experimental conditions described, it was concluded, that no evidence of eye irritation properties was seen after treatment 2-ethylhexyl benzoate.


Justification for selection of skin irritation / corrosion endpoint:
The study is GLP compliant and has Klimisch score 1.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

The available data on the skin and eye irritating potential of 2-ethylhexyl benzoate do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.