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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to OECD guideline but not in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: ''pure''
Batch No.: not specified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann
- Age at study initiation: 9 weeks
- Weight at study initiation: 166 grams (mean)
- Fasting period before study: 16 hours
- Housing: 5 animals/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5°C
- Humidity (%): 60±5%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
None stated
Doses:
0.8, 1.0, 1.1, 1.2, 1.3, 1.5 and 1.8 mL/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2 times/day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and histopathology
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 430 mg/kg bw
Based on:
test mat.
95% CL:
>= 1.33 - <= 1.54
Mortality:
Dose: 0.8 mL/kg. Mortality: 0/10 animals.
Dose: 1.0 mL/kg. Mortality: 1/10 animals.
Dose: 1.1 mL/kg. Mortality: 1/10 animals.
Dose: 1.2 mL/kg. Mortality: 5/10 animals.
Dose: 1.3 mL/kg. Mortality: 7/10 animals.
Dose: 1.5 mL/kg. Mortality: 9/10 animals.
Dose: 1.8 mL/kg. Mortality: 10/10 animals.
Clinical signs:
Sedation, staggered, weightloss, rough coat, illness were observed.
Body weight:
No information provided
Gross pathology:
No information provided
Other findings:
No information provided

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute LD50 in an acute oral toxicity study with the test substance in rats appeared to be approximately 1430 mg/kg bw.
Executive summary:

This study was conducted according to a method which equivalent or similar to OECD guideline 401 using rats.

The acute LD50 in an acute oral toxicity study with the test substance in rats appeared to be approximately 1430 mg/kg bw.