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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance is non toxic after single oral and dermal exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
4 600 mg/kg bw
Quality of whole database:
The study is of sufficient quality (Klimisch score=2)

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:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant and is of high quality (Klimisch score=1)

Additional information

Acute toxicity: oral

The acute oral toxicity of the test substance was low with an LD50 value > 4600 mg/kg bw (5 ml/kg bw) for male rats (similar to OECD TG 401). Single administration of 4600 mg/kg bw was tolerated without mortality and without signs of intoxication by all animals. Body weight development was not affected (Beyer, 2008).

Acute toxicity: dermal

The acute dermal toxicity of the test substance was low with an LD50 value > 2000 mg/kg bw for male and female rats according to OECD TG 402. Single semiocclusive administration of 2000 mg/kg bw for 24 hours was tolerated without mortalities. Local signs were observed in male ( thickening and partial: reddening, indurations and blue indurations, encrustation and formation of scale of the treatment area) and female ( thickening and partial: reddening, encrustation and indurations of the treatment area) animals. Body weight development was not affected in males, whereas two females revealed a decreased body weight gain during the 14-day post observation period (Gillissen, 2009).

Acute toxicity: inhalation

This information is not available. Since acute oral and dermal toxicity studies are available and the most appropriate route for human exposure is by oral intake, inhalation toxicity studies do not need to be conducted.


Justification for selection of acute toxicity – oral endpoint
Only one study available

Justification for selection of acute toxicity – dermal endpoint
Only one study available

Justification for classification or non-classification

Acute toxicity: oral

Not classified under Annex I of Directive 67/548/EEC. According to Annex I of Regulation (EC) No 1272/2008 no classification is required for acute oral toxicity (LD50: > 4600 mg/kg bw).

Acute toxicity: dermal

Not classified under Annex I of Directive 67/548/EEC. According to Annex I of Regulation (EC) No 1272/2008 no classification is required for acute dermal toxicity (LD50: > 2000 mg/kg bw).

Acute toxicity: inhalation

Not classified under Annex I of Directive 67/548/EEC or Annex VI-1 of Regulation (EC) No 1272/2008.