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Description of key information

A single dose of 2000 mg/kg bw of the test substance was administrated dermal to groups of male and female rats (5/sex, OECD guideline 402). Application of the test substance did not induce any sings of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. However, single oral administration of the test item (OECD 401) to rats leads to dyspnoe, reduced spontaneous activity and hunched posture. All female animals of the high dose group (2000 mg/kg bw) died until day 3 of the post observation period. LD50 after single dermal administration is 2000 mg/kg bw, after single oral administration 1000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 000 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

Procedure and observations

 

To evaluate the acute oral toxicity, a single dose of the test article was administrated to a group of 5 male (500 and 1000 mg/kg bw) or 5 female (1000 and 2000 mg/kg bw) rats by oral gavage. Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing once a week.

Ruffled fur, dyspnoea, and abnormal body positions were seen. Additionally, reduced spontaneous activity was observed during the application day and day 1 after application. All female animals of the high dose group (2000 mg/kg bw) died until day 3 of the post observation period. Oedematous lungs were found in one female and a liquid-filled thoracic cavity in three females of the high dose group, respectively. 

 

Dermal toxicity of the test substance was evaluated on a group of five male and 5 female RAI f (SPF) rats which were treated with the test article at 2000 mg/kg by dermal application. The substance was suspended in peanut oil and administered at a volume of 4 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs and viability. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. Ruffled fur and dyspnoea were seen during post observation period. Macroscopic organ findings were not observed at necropsy.

 

Discussion

Oral application of the test item at concentrations of 2000 mg/kg bw leads to death of all animals. Macroscopic examination revealed oedematous lungs and liquid filled thorax. Other clinical signs were dyspnoea, exophthalmia and a decrease in spontaneous activity. These data indicate that the test substance is well absorbed and metabolized into products which might inhibit biochemical processes, liver function or regulation of blood pressure. LD50 is considered to be 1000 mg/kg bw.

Dermal application of the test article did not cause unscheduled mortalities or any sings of toxicity. Thus, LD50 is considered to be 2000 mg/kg bw.

Acute toxicity after inhalation of the test substance was not estimated. The substance is a solid and has a particle size of approximately 153 µm. Therefore the test article is not inhalable.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for acute oral toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for acute oral toxicity under Regulation (EC) No. 1272/2008.

The substance is classified as harmfull if swallowed and labeled with R 22 or H302, respectively.