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Administrative data

Description of key information

The acute toxicity of the test item was investigated in an acute and dermal toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral or dermak administration. Hence, the LD50 is above 2000 mg/Kg bw.

The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f.

Based on the absence of systemic effects after acute oral and dermal administration, a study on acute inhalation toxicity is not required.

Furthermore, based on the lack of systemic toxicity after acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

In an acute oral toxicity study, one group of fasted, young adult Wistar rats (3/sex) were given a single oral dose of the test substance with aqueous Methocel® K4M Premium solution (2.5 g/L) as vehicle at a dose of 2000 mg/kg bw and observed for 14 days.

Oral LD50:

Males > 2000 mg/kg bw

Females > 2000 mg/kg bw

Combined > 2000 mg/kg bw

No mortality occurred in this limit test.

The test subsance is of low Toxicity based on the LD50 in male and female rats.

There were no treatment related clinical signs, necropsy findings or changes in body weight.

Dermal route:

In an acute dermal toxicity study, one group of young adult Wistar rats (5 /sex) were dermally exposed to test substance in liquid paraffin for 24 hours to the shaven body surface area of 6 x 6 cm of at a limit dose of 2000 mg/kg bw. Animals then were observed for 14 days.

Dermal LD50:

Males > 2000 mg/kg bw

Females > 2000 mg/kg bw

Combined > 2000 mg/kg bw

No mortality occurred in this limit test.

the test substance is of low Toxicity based on male and female animals.

No signs of toxicity were detected in the rats (5 males and 5 females) after treatment with 2000 mg/kg. No deaths occurred during the course of the study. There were no treatment related clinical signs, necropsy findings or changes in body weight.

Justification for classification or non-classification

Based on the results for acute oral and dermal toxicity in rats, the

test substance

is considered to have no acute toxic potential. The expected LD50 values are higher than 2000 mg/kg bw after oral and after dermal administration to rats. Therefore, the

test substance

is not classified according to EU Regulation No.1272/2008.