Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
The test substance was administered orally by gavage at single dose to a group of experimental animals. Subsequently observations of effects and deaths were made. At the end of the observation period the surviving animals were sacrificed and autopsied.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
Name: FAT 40075/A
Purity: 74.5 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 234 g (males), 160 g (females)
- Fasting period before study: 18 h
- Housing: Rats were caged singly
- Diet: Commercial pelleted diet (ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C.
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: deionised water
Details on oral exposure:
The test substance was administered as a single dose by gavage as a 25 % w/v solution in deionised water at a rate of 20 mL/kg (equivalent to 5 g/kg bw of test substance) to rats which had been fasted for 18 h.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 d.
- At the end of the observation period, surviving animals were killed by exsanguinations under other anaesthesia and an autopsy performed.
- Other examinations performed: Mortality, clinical symptoms.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 725 mg/kg bw
Based on:
act. ingr.
Mortality:
No death occurred during the study
Clinical signs:
No clinical signs were observed during the study period.
Gross pathology:
No changes in organs or tissues were observed at autopsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of the test substance was found to be >5000 mg/kg bw (i.e. ca. >3725 mg a.i./kg bw) in rats.
Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance (of ca. 74.5 % purity) in Sprague-Dawley rats. This test was conducted in accordance to guideline similar to OECD 401. Group of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 5000 mg/kg bw. Parameters assessed included mortality, clinical symptoms and autopsy findings after a 14 d observation period. No mortality and no clinical symptoms were observed throughout the observation period and no significant changes in organs or tissues were seen at autopsy. Under the study conditions, the oral LD50 of the test substance was found to be >5000 mg/kg bw (i.e. ca. >3725 mg a.i./kg bw) in rats.