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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In an acute oral toxicity study the oral LD50 value for the test substance was determined to be 600 mg/kg bw.

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:
1980
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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: FDRL
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: fasted overnight prior treatment
- Diet: Purina Laboratory Chos, ad libitum
- Water: ad libitum
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
no data
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: closely observed for mortality and pharmacological effects on the day of dossing and daily thereafter for a total of 14 observation days; body weight determination prior to dosing
Statistics:
LD50 values were calculated by appropriate statistical methods, as determined by Miller and Tainter (1944).
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Based on:
test mat.
95% CL:
501 - 699
Mortality:
no data
Clinical signs:
other: no data
Gross pathology:
no data
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 value for the test substance was determined to be 600 mg/kg bw.
Executive summary:

An acute oral toxicity study was conducted on 10 rats (5 male and 5 female animals). After an overnight fasting period the animals were weighted and the test item was applied by gavage in corn oil. The animals were observed for a period of 14 days. The calculated LD50 for the test item was 600 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
600 mg/kg bw
Quality of whole database:
Summary of study results, basic information given, sufficient for assessment.

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

An acute oral toxicity study was conducted on 10 rats (5 male and 5 female animals). After an overnight fasting period the animals were weighted and the test item was applied by gavage in corn oil. The animals were observed for a period of 14 days. The calculated LD50 for the test item was 600 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on this data, the substance is considered to be classified for acute oral toxicity (Cat. 4, H302) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.