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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 test item was tested for acute oral toxicity and for acute dermal toxicity. The test item revealed an oral LD50 greater 2000 mg/kg bw in rats. The test item revealed a dermal LD50 greater 2000 mg/kg bw in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and guideline study is available (Klimisch 1).

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:
GLP and guideline study is available (Klimisch 1).

Additional information

Acute oral toxicity:

The acute oral toxicity of the undiluted test item was investigated in Wistar rats according to OECD guideline no. 423 and EU method (acute toxic class method). 2000 mg/kg bw of the undiluted test item was administered to two test groups of three fasted Wistar rats by gavage. Dose of 2000 mg/kg bw were administered to the first group of 3 female rats. Dose of 2000 mg/kg bw were administered twice to the another group of 3 female rats. No mortality was occurred. No signs of systemic toxicity were observed. The mean body weight of the animals increased within the normal range throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute oral median lethal dose (LD50) was determined to be LD50, oral, rat > 2000 mg/kg bw.

Acute dermal toxicity:

The acute toxicity of undiluted test item was investigated in Wister rats according to OECD guideline no 402 and EU method B.3. In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test item to the clipped skin (dorsal and dorsolateral parts of the trunk) and covered by semi- occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality was occurred. No signs of systemic toxicity and no signs of skin effects were noted. The mean body weight of the animals increased within the normal range throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw.


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

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

Justification for classification or non-classification