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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral

A study was conducted to assess the acute oral toxicity of test substance in Sprague-Dawley CD rats according EU Method B.1 tris.

 

Following a range-finding study, a group of 6 fasted rats (three males and three females) were given a single oral dose of the test substance as a 20 % suspension in sesame oil, at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. There were no mortalities in the study. Red discolored urine was observed in all animals on the first day of the study and on Day 2 in the male animals. From Day 3 until the end of the study no symptoms were observed. Two female animals showed a reduced body weight gain in wk 2. In all other animals the development of body weight was not impaired. No abnormalities were noted at necropsy. The acute oral LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley CD rats (Dr. Kauffmann HM, 2002).

Dermal

A study was conducted to assess the acute dermal toxicity of test substance in Sprague-Dawley CD rats according EU Method B.3., OECD guideline 402 and OPPTS 870.1200.

Following a range-finding study, a group of 10 rats (five males and five females) were applied 0.5 g of test substance moistened with 0.28 mL sesame oil, at a dose level of 2,000 mg/kg. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d and were then killed and subjected to gross pathological examination. No mortality was observed in the study. From Day 2 of the study up to Day 5 (male group) and up to Day 7 (female group) a slight erythema of the skin was observed. The overall body weight gain was not impaired in both sexes. The animals killed at the end of the observation period showed no macroscopically visible changes. The acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley SD rats (Dr. Kauffmann HM, 2002).

The available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw) and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).

Justification for classification or non-classification

The available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw) anddoes not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).