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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:
October 22, 1979 - November 5, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
This information is used for read-across to Jessemal.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No details on test material, no purity, no details on environmental conditions.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Wistar-strain albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Suitable licensed dealer
- Age at study initiation: approx. 6 to 8 weeks
- Weight at study initiation: 200 - 238 g
- Fasting period before study: approx. 18 hours
- Housing: Animals were housed in galvanized cages with indirect bedding
- Diet: Free access to diet consisted of a growth and maintenance ration from a commercial producer
- Water: Free access to water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Individual doses, calculated on the basis of bodyweight, were administered using a stainless steel intragastric feeding needle.
Doses:
5000 mg/kg bodyweight
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: The animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6 and 24 hours after application and thereafter daily.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed, necropsied and subjected to complete gross necropsy, with all findings noted.
- Body weights: Individual body weights were recorded immediately before treatment and then on the 14th day of the observation period.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Slight depression was oberserved among all animals at 3, 6 and 24 hours after application of the substance.
Body weight:
Normal bodyweight increases were observed on the 14th day of the observation period.
Gross pathology:
No gross changes were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not acutely orally toxic
Remarks:
according to EU CLP(EC No. 1272/2008 and its amendments)
Conclusions:
The acute oral toxicity test showed an LD50 of >5000 mg/kg bw
Executive summary:

In this study performed equivalent to OECD TG 401 guideline and GLP principles, 10 rats (5 males and 5 females) were administered to the substance at a dose level of 5000 mg/kg bw. No deaths occurred. Slight depression was oberserved among all animals at 3, 6 and 24 hours after application of the substance. Normal bodyweight increases were observed on the 14th day of the observation period. No gross changes were observed. The acute oral LD50 for the substance in male and female rats was determined to be >5000 mg/kg bw.

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