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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral toxicity: Supporting study. The LD50 of the test item is higher than 11250 mg/kg body weight by oral route in the rat.

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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5.0, 7.5 and 11.25 g/kg bw.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: not specified
- Necropsy of survivors performed: no specified
- Other examinations performed: clinical signs, body weight and time of death
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
11 250 mg/kg bw
Based on:
test mat.
Gross pathology:
no data
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 of the test item is higher than 11250 mg/kg body weight by oral route in the rat.

Executive summary:

The LD50 of the test item is higher than 11250 mg/kg body weight by oral route in the rat. At the dose of 11.25 g/kg bw, body weight gain was slightly suppressed, which was not observed at a dose of 5.0 or 7.5 g/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
11 250 mg/kg bw
Quality of whole database:
Supporting study with Klimisch score 4.

Additional information

Justification for classification or non-classification

Based on the available data, the substance is not classified for acute toxicity according to CLP Regulation (EC) no. 1272/2008.