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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Oral

Key study:

In an acute oral gavage study in male rats performed under conditions similar to the OECD 401 guideline, the LD50 of the test material was 11300 mg/kg.

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:
11 February 1981 to 04 March 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
- Date received: 28 January 1981
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
- Housing: The animals were housed and maintained in compliance with the U.S. Animal Welfare Act (Pub. L- 94- 279) 9 CFR Part 3.
- Weight: Between 200 and 300 g.
- Feeding / water: The animals were allowed food and water ad libitum, except that they were deprived of food overnight prior to dosing.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1.0, 2.0, 4.0, 8.0 and 16.0 g/kg
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- 14 day observation period
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
11.3 other: g/kg
Based on:
test mat.
95% CL:
> 7.7 - < 16.7
Mortality:
No mortality was observed in the 1.0, 2.0 and 4.0 g/kg dose groups. One death occurred in the 8.0 g/kg dose group and 4 mortalities were observed in the 16.0 g/kg dose group, where the deaths occurred after 3-4 hours. The sole surviving animal remained in poor health for 3 days before recovering.
Clinical signs:
other: No unusual signs were noted at 1.0, 2.0 and 4.0 g/kg. The 8.0 g/kg, the animals appeared depressed, ruffled and slightly ataxic within 3-4 hours dosing. Animals at 16.0 g/kg were severely depressed, ruffled, dirty, drooling and ataxic within 2 hours after
Gross pathology:
Gross pathologic examination revealed nothing remarkable relating to test material administration.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral of the test material was LD50 of 11300 mg/kg,
Executive summary:

In an acute oral gavage study in male rats performed under conditions similar to the OECD 401 guideline, the LD50 of the test material was 11300 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
11 300 mg/kg bw
Quality of whole database:
1

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