Registration Dossier

Administrative data

Description of key information

The acute oral toxicity LD50 of the registered substance is 1220 mg/kg bw. 
Using a read across approach with a close homologue the acute dermal toxicity is considered to be > 8410 mg/kg bw but < 10000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 220 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
Value:
8 410 mg/kg bw

Additional information

The registered substance was assessed for its acute oral toxicity using the OECD 401 protocol. Four dose levels between 0.5 and 5 g/kg bw were applied to SD rats and a control group receiving the vehicle was assigned. 5 male and 5 female animals were assigned to each dose group. The LD50 was determined to be 1220 mg/kg bodyweight using a linear regression model. The test substance is assigned to acute toxic Category 4.

The acute dermal toxicity of the registered substance was assessed in a study according to the FDA, cf. 16 CFR 1500.40 guideline. 3 male and 3 female white rabbits were dosed with 8410 mg/kg bw using an occlusive patch for 24 hours. All animals survived until the end of the observation period (14 days). At the higher dose levels of 10000, 12600, 15870 and 200000 mg/kg, an inconstistent death pattern was observed with the 3 males and 3 females tested at each dose level. Based on the available data, the LD50 of the test substance was greater than 8410 mg/kg bodyweight but less than 10000 mg/kg bodyweight. The test substance is thus considered practically non-toxic.

Since inhalation is no primary route of exposure the registered substance was not tested for this endpoint.

Justification for classification or non-classification

By applying the GHS classification system for chemical substances according to Regulation (EC) 1272/2008 the registered substance has to be labelled as Category 4 for its acute oral toxicity.