Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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
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. QA statement)
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.