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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Rat: LD50 (m/f) > 2200 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 200 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

No information on the "acute oral toxicity" of the Target Substance is available. However data on Similar Substance 01 has been taken into account for the assessment. More details about the substance similarity is reported in section 13.

The acute oral toxicity of the test substance was investigated in two groups of 3 male and 3 female rats according to EU B.1/OECD 401 guideline, given a limit dose of 2200 mg/kg bw as gavage. Clinical signs were discoloured feces for male and female rats and piloerection and smeared fur in the anogenital area in male animals. No mortality or gross pathological changes were reported.

In the second study the acute oral toxicity of the test substance was investigated according to OECD guideline 401 in two groups of 3 male and 3 female rats, given a limit dose of 5000 mg/kg bw as gavage. Clinical signs were black feces for male and female rats. No mortality or gross pathological changes were reported.

 

Justification for classification or non-classification

Based on the criteria defined by the EU and the CLP criteria, the test substance needs not to be labelled for acute oral toxicity because no death occurred in the highest dosing group of 2200 mg/kg bw in male and female animals that could be attributed to the test substance administration.