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Administrative data

Description of key information

Oral (OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The acute toxicity of ethyl 3,5-dichloro-4- hexadecyloxycarbonyloxybenzoate (AF-366) was assessed in an oral toxicity study and a dermal toxicity study.

In an acute oral toxicity study performed according to OECD guideline 401, the limit dose of 5000 mg/kg of the test substance was administered to 5 rats/sex by gavage (Spanjers, 1988a). No mortality was observed, and there were no effects on body weight during the 14-day observation period. The necropsy and gross pathological examination did not reveal any treatment-related effects. Therefore, the LD50 is > 5000 mg/kg bw for male and female rats.

The acute dermal toxicity of ethyl 3,5 -dichloro-4 -hexadecyloxycarbonyloxybenzoate was assessed in a limit test that was performed according to OECD 402 (Spanjers, 1998b). A single dose of 2000 mg/kg bw of the test substance was applied as a 25% solution in maize oil to the shaved skin of rats under occlusive conditions and left for 24 hours. There was no mortality during the 14-day observation period. The mean body weight of the females was reduced from day 3 until sacrifice on day 14. The necropsy and gross pathological examination did not show any treatment-related effects. Therefore, the LD50 (dermal) is > 2000 mg/kg bw for male and female rats.

Justification for classification or non-classification

The available data on acute toxicity of the test substance does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.