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Description of key information

The LD50 of the source substance is 1310 mg/kg bw. In consideration of the molecular weight of both substances (208.25 and 194.2 g/mol), the corrected LD50 for the target substance is 1406.2 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 406 mg/kg bw
Quality of whole database:
The data has been derived from a read-across substance.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The study was performed on the read-across substance isobutyl salicyclate in order to assess the acute oral toxicity.

The methodology of the study was not described, therefore, it is assumed it was not according to OECD guideline. it was not indicated that study was according to GLP as well.

In total 50 rats (10 rats/dose) were treated by oral route with a single dose of the test item at dose 830 mg/kg, 1040 mg/kg, 1310 mg/kg and 5000 mg/kg.

Following the dosing, the animals were observed during 14 days. At the level 1040 mg/kg, 3/10 animals died on Day 2 after dosing. At dose level 1310 mg/kg bw 5/10 animals died (3 on Day 1 and 2 on Day 2 after dosing). At dose level 2050 mg/kg 8/10 animals died (1 on Day 1 and 7 on Day 2 after dosing). At dose level 5000 mg/kg, 9/10 animals died (3 on Day 1, 5 on Day 2 and 1 on Day 3 after dosing). The LD50 was 1310 mg/kg bw. In consideration of the molecular weight of both substances (208.25 and 194.2 g/mol), the corrected LD50 for the tagret substance is 1406.2 mg/kg.

Justification for classification or non-classification

A classification is required as acute oral toxic Cat 4 according to Regulation (EC) No 1272/2008.