Registration Dossier

Administrative data

Description of key information

Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off value, limit test)
Dermal (OECD 403), rat: LD50 ≥ 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

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

Additional information

The acute toxicity of TS-2863 (2-(2 -hexyl-decyloxy)-benzamide) was assessed in an oral toxicity study and a dermal toxicity study. No inhalation toxicity study is available.

In an acute oral toxicity study (performed according to OECD 423), the limit dose of 2000 mg/kg bw TS-2863 was first administered to 3 male and then to 3 female rats by gavage, in two steps (Pels Rijcken, 1998). There was no mortality and no effects on body weight during the 14-day observation period. Lethargy, hunched posture and uncoordinated movements were noted among 3/3 males and 3/3 females on day 1 until 4 hours after dosing, most likely due to the treatment by gavage. The necropsy and gross pathological examination did not reveal any treatment-related effects. According to the acute toxic class method described in the OECD guideline 423, if there is no mortality following administration of 2000 mg/kg bw in two separate steps, the LD50 cut-off value is 5000 mg/kg bw. Therefore, the LD50 is considered to be 5000 mg/kg bw for male and female rats.

The acute dermal toxicity of TS-2863 was assessed in a limit test performed in 5 rats/sex, according to OECD 403 (Pels Rijcken, 1998). A single dose of 2000 mg/kg bw of the test substance (moistened with water) was applied to the shaved skin of rats under occlusive conditions and left for 24 hours. There was no mortality, no clinical signs and no effects on body weight during the 14-day observation period. The necropsy and gross pathological examination did not show any treatment-related effects. Erythema (grade 1 on a scale of 4), scales and/or scabs were noted in the treated skin area of all animals after removal of the dressing. The erythema had cleared completely in all animals by day 9 and the scales/scabs by day 11 of the study period. The LD50 for systemic toxicity is considered to be > 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral and dermal toxicity of the test substance 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.