Registration Dossier

Administrative data

Description of key information

LD50 oral (rat, mouse, hamster): >6000 mg/kg bw (m+f)

LD50 dermal (rat): >2000 mg/kg bw (m+f)

LD50 intraperitoneal (rat): >2000 mg/kg bw (m+f)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 000 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 adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The substance was tested for acute toxicity via oral, dermal and intraperitoneal application to different species.

Acute oral toxicity:

All available studies on acute oral toxicity are regarded as key studies. This is based on an overall comparable method and same dose schedule. The only difference is ascribed to species used.

An LD50 of > 6000 mg/kg bw was identified via oral application for all species.

Acute dermal toxicity:

Test substance is moreover found to be not acute toxic via dermal application. LD50 value of > 2000 mg/kg bw was identified.

Other route:

Test substance was found to be not acute toxic via intraperitoneal route. LD 50 values of > 2000 mg/kg were identified.

In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure.

Since no toxic effects, neither local nor systemic, occurred via dermal and oral application routes, it can be assumed that inhalative acute toxicity is of no relevance.

Test substance is therefore considered not acute toxic.

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the test substance with regard to acute toxicity.

Test substance is not classified for acute toxicity via oral or dermal route in accordance with the CLP Regulation (EC) No 1272/2008.