Registration Dossier

Administrative data

Description of key information

Acute toxicity: Oral LD50 (rat, m/f): > 2500 mg/kg bw (OECD 423)
Acute toxicity: Dermal LC50 (rat, m): > 5000 mg/kg bw (OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

Oral

The acute oral toxicity of 2-ethylhexyl benzoate was evaluated in rats in accordance with OECD guideline 423 under GLP conditions (Blanchard, 2000).

Sprague-Dawley rats (males and females) were stepwise dosed with the test material (5000 and 2000 mg/kg bw) using three animals of a single sex per step.

At 5000 mg/kg bw 1/3 females and 2/3 males died 48 h post-dose. In the next step at 2000 mg/kg bw only one female animal died (72 h post-dose). All animals showed clinical signs of abnormal gait and hunched posture and further signs were apparent in single animals e.g. lethargy, reduced body temperature being fully reversible within 3 days.

Reduced body weight was observed in one female at 2000 mg/kg bw on Day 8 only.

Necropsy revealed no substance-related findings.

Therefore, the oral LD50 for male and female rats was considered to be 2500 mg/kg bw according to the cut off values of OECD guideline 423.

 

Inhalation

This information is not available.

 

Dermal

The acute dermal toxicity of 2-ethylhexyl benzoate was evaluated according to OECD guideline 403 under GLP conditions (Blanchard, 2000).

A group of five Sprague-Dawley rats (males and females) were treated in a limit test with 5004 mg/kg bw of the test substance.

No mortality occurred during the study period in any animal. No systemic clinical signs of toxicity were observed up to the end of the 14-day observation period. Transient very slight dermal irritation was seen in all animals following removal of the dressing, resolving completely by Day 4.

A loss in body weight was recorded for one female and low body weight gains were noted for the 4 remaining females on Day 8. All other animals were considered to have achieved satisfactory body weight throughout the study.

Necropsy revealed no substance-related findings.

Therefore, the dermal LD50 for male and female rats was considered to be greater than 5000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

The available data on acute toxicity of 2-ethylhexyl benzoate do not meet the criteria for classification according to Regulation (EC) 1272/2008, and the data are therefore conclusive but not sufficient for classification.