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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

LD50 (oral, rat) > 5000 mg/kg bw

LD50 (dermal, rat) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Acute oral toxicity

In the oral toxicity study performed by Seguier (2008) according to OECD 423 and GLP, 6 female Wistar rats were treated with 2000 mg/kg bw of the test substance in water by gavage. After application of the test substance and during the 14 day-observation period, no mortality occured, no clinical signs and no effects on the body weight gain were observed in any animal. Macroscopic examinations at necropsy did not reveal any abnormalities.

According to the acute toxic class method described in the OECD guideline 423, if there is no mortality following administration of 2000 mg/kg bw in two separate steps, the LD50 cut-off limit is 5000 mg/kg bw. Therefore, the LD50 is considered to be 5000 mg/kg bw for female rats.

Acute dermal toxicity 

The acute dermal toxicity of the test substance was investigated in a study performed according to OECD 402 and GLP (Seguier, 2008). A single test substance dose of 2000 mg/kg bw was applied on the skin of five male and five female Sprague-Dawley rats. The treated skin site was covered with a semiocclusive dressing for 24 h. No mortality occurred during the 14 day-observation period. No clinical signs and no changes on body weight were observed and the necropsy revealed no test substance-related findings. Therefore, the LD50 is > 2000 mg/kg bw for male and female rats.

Justification for selection of acute toxicity – oral endpoint

There is only one study available.

Justification for classification or non-classification

The available data on the acute oral and dermal toxicity of the test substance does not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and is therefore conclusive but not sufficient for classification.