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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
purity not indicated, body weighs not given, no data for individual animals

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no data for single animals, body weight not recorded.
Principles of method if other than guideline:
20 young adult rats were used in this study to determine the range of toxicity. The material was administered to ether-sedated fasted animals as a suspension in DMSO/corn oil (50/50) heated to 50 °C. Controls were given DMSO/corn oil (50/50) only. The dose was given intragastrically with a ball-tipped needle and syringe. After treatment, all animals were observed daily for 30 days for aberrant physiological and behavioral responses
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Storage condition of test material: 25 °C in a glass container sealed inside a polyethylene bag

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 67 days
- Weight at study initiation: 250 - 270 g
- Fasting period before study: Yes

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: DMSO/corn oil (50/50)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL
- Justification for choice of vehicle: Insoluble in water

DOSAGE PREPARATION (if unusual): 5 g of test material were dissolved in 5 mL of DMS0 at 50 °C. This solution was diluted with 5 mL of corn oil, which formed a suspension of the test substance in the liquid medium. This suspension was kept at 50 °C until administration was completed.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Preliminary study
Doses:
5 g/kg
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 30 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: aberrant physiological and behavioral responses

Results and discussion

Preliminary study:
Because the LD50 was greater than 5 g/kg, the material was considered to be nontoxic.
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Mortality:
none
Clinical signs:
The report gives a general assessment that all behavioural and physiological responses were normal.
Body weight:
not recorded
Gross pathology:
not mentioned
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Because the LD50 was greater than 5 g/kg, the material was considered to be nontoxic.