Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2018

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
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

Applicant's summary and conclusion

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.