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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3-18 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
Due to technical reasons, relative humidity values (maximum of 80%) outside the expected ranges of 30-70% were recorded occasionally during the study.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mL/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
slightly decreased activity (6 out of 6 animals), hunched back (6 out of 6 animals), sneezing (6 out of 6 animals) and piloerection (4 out of 6 animals), fully reversible 5 days after exposure.
Body weight:
No effects
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 is >2000 mg/kg
Executive summary:

The acute oral toxicity has been assessed by exposure of the substance to 6 female wistar rats at a concentration of 2000 mg/kg according to the OECD 423 test guideline. No toxicity has been observed and the LD50 is determined to be >2000 mg/kg.

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

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The acute oral toxicity has been assessed by exposure of the substance to 6 female wistar rats at a concentration of 2000 mg/kg according to the OECD 423 test guideline. No toxicity has been observed and the LD50 is determined to be >2000 mg/kg.