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Administrative data

Description of key information

In an acute oral toxicity study on rats, the Oral LD50 was found to be superior to 5 mL/kg. (pre- GLP, Rel. K2)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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 study available

Additional information

In an acute oral toxicity study performed similar to the OECD Guideline 401, a single dose of 5 mL/kg bw of undiluted test substance was given by oral gavage to a group of 5 male and 5 female Sprague Dawley rats. Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.

Only 1 male died within a 48-hour period. Toxic symptoms consisted of slight salivation, slight ataxia, slight respiratory depression and a slight decrease in spontaneous activity started 1 hour after dosing and persisted through 4 hours. By 24 hours, all animals appeared normal except one male which was unconscious and died. Mean body weight gains in females and males were 44 and 88 g, respectively. No gross pathological changes were noted upon necropsy.

Rat Oral LD50 >5 mL/kg bw.

Justification for classification or non-classification

Self classification:

Acute toxicity via Oral route:

Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is greater than 5 mL/kg bw