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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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
No details available.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
No details available
Doses:
3.2, 4.0. 5.0 and 6.25 ml/kg
No. of animals per sex per dose:
10M
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: 1 and 6 hours after dosing, once per day thereafter.

- Necropsy of survivors performed: yes
Statistics:
Method not stated

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4.6 mL/kg bw
Based on:
test mat.
95% CL:
3.9 - 5.3
Mortality:
See Table 1
Clinical signs:
Slight ataxia and lethargy.
Body weight:
Not reported
Gross pathology:
There were no abnormalities in any animals at necropsy.
Other findings:
None reported.

Any other information on results incl. tables

The LD50 of the compound calculated from the data obtained is 4.6 ml/kg with 95% confidence limits of 3.9 ml/kg and 5.3 ml/kg. No abnormalities were noted in any of the animals at necropsy. Doses and number of deaths were:

Dose (ml/kg)

Deaths

3.2

1/10

4

4/10

5

6/10

6.25

8/10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study with male Wistar rats, the LD50 was determined to be 4.6 ml/kg.