Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 > 5000 mg/kg bw, OECD Guideline 401
Acute dermal toxicity: LD50 > 2000 mg/kg bw, OECD Guideline 402

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The available studies are GLP compliant and have been scored with Klimisch 1 reliability.

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
2 000 mg/kg bw
Quality of whole database:
The available studies are GLP compliant and have been scored with Klimisch 1 reliability.

Additional information

This substance has been investigated in two acute oral toxicity studies and two acute dermal studies. All studies consistently show absence of mortality and target organ toxicity. All studies were performed according to GLP and OECD guidelines.

For acute oral toxicity, the two studies available were performed with doses of up to 5000 mg/kg bw studied with male and female rats of different strains (Albino rats and Crl CDBR). The test animals were feeded with the substance in oral gavage. No mortality and no treatment-related clinical signs were recorded in any of the two studies. As a conclusion, acute oral toxicity is therefore considered low.

For acute dermal toxicity, the two studies available were performed with rats (Sprague Dawley). In both studies, the substance was appliead in a semi-occlusive coverage with vehicles liquid paraffine and arachis oil respectively. The substance applied was 2000 mg/kg and after the observation period of 24h there was no mortality, no clinical signs and no effect on body weight gain. Any dermal effects were observed during the treatment or after. As a conclusion, acute dermal toxicity is therefore considered low.

There isnt't any acute inhalation toxicity study available. This exposure route has been considered as non likely to occur.

Justification for selection of acute toxicity – oral endpoint
There are two test results available, with same results.

Justification for selection of acute toxicity – inhalation endpoint
Data waiving: exposure route not likely to occur.

Justification for selection of acute toxicity – dermal endpoint
There are two test results available, with same results.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The values obtained have been compared to the limit values as stated in the Annex I of the Regulation (table 3.1.1.). As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.