Registration Dossier

Administrative data

Description of key information

The LD50 value for male and female animals p.o. is greather than 10 000 mg/kg bw.
The LD50 value for male and female animals dermal is greather than 2 000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
10 000 mg/kg bw
Quality of whole database:
Test according to OECD guideline 401 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.

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:
Test according to OECD guideline 402 and according to the OECD-GLP regulations, fixed in the Chemikaliengesetz 1990, but lack of data on the purity / quality of the sample tested.

Additional information

The acute oral toxicity of Hydroxyambran was determined according to the OECD Test Guideline 401 in a limit test with 10 000 mg/kg bw in rats.

No animals died during the course of the study.

Abnormal clinical signs were observed only within 1h - 48h p.a.

Weight gains were normal in all animals.

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

The LD50 value for male and female animals p.o. is greather than 10 000 mg/kg bw.

The acute dermal toxicity of Hydroxyambran was determined according to the OECD Test Guideline 402 in a limit test with 2 000 mg/kg bw in rats.

No animals died during the course of the study.

No abnormal clinical signs were observed.

Weight gains were normal in all animals.

Gross pathological examinations at 14 days p.a. (terminal necropsy) revealed no test article-dependent findings.

The LD50 value for male and female animals dermal is greather than 2 000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Only abnormal clinical signs were observed within 1h - 48h p.a, not any other adverse effect was observed.
No animals died during the course of the study using a dosis of 10 000 mg/kg bw.

Justification for selection of acute toxicity – dermal endpoint
Apart from slight erythema and oedeme in one female animal on the administration area until day 2, not any other adverse effect was observed.
No animals died during the course of the study using a dosis of 2 000 mg/kg bw.

Justification for classification or non-classification