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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientific acceptable and well documented
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: 84/449/EWG
Principles of method if other than guideline:
5 male mice, 5 male hamster and 6 male and female guinea received a single oral application per gavage of 200 or 2000 mg/kg bw of the test substance. Post-exposure period was 14 days.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.1%

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male
Details on test animals and environmental conditions:
according to their weight animals were 10 to 13 weeks old at the start of the study. husbandry: standardised conditions, animals were housed in makrolon cages

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: physiol. saline/Cremophor 2%
Details on oral exposure:
16 hours before and 4 hours after the application of the test substance the animals were fastened
Doses:
200, 2000 mg/kg bw
No. of animals per sex per dose:
5 male mice per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the post observation period of 14 days animals were inspected twice daily (daily on weekend) and time of onset, duration, and severity of clinical signs recorded, animals were weighened before, after 1 week and at the end of the post-observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
not applicable - estimation of the mean lethal dose on the basis of the dosage of 200 and 2000 mg/kg bw

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
200 - 2 000 mg/kg bw
Mortality:
dose 200 mg/kg bw, mortality 0/5; dose 2000 mg/kg bw, mortality 5/5
Clinical signs:
a dose of 200 mg/kg bw was tolerated without symptoms. with 2000 mg/kg bw all mice revealed sedation, apathy and tremor on the same day of application of the test substance
Body weight:
body weight gain was not influenced on mice treated with 200 mg/kg bw. mice treated with 2000 mg/kg bw died within one day after application of the test substance
Gross pathology:
some of the animals killed at the end of the experiment revealed sparse collapsed lungs. 2 out of 5 mice administered a dose 2000 mg/kg bw revealed changes of stomach and/or intestines (black and red colored areas of the stomach mucosa and black-brown discoloration of the intestine contents
Other findings:
a dose of 2000 mg/kg bw caused in some animals a storage of fine droplets of fat in the hepatocytes

Any other information on results incl. tables

Mortality 0/5 after administration of 200 mg/kg bw,
Mortality 5/5 after administration of 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Executive summary:

Method: 5 male mice received a single oral application per gavage of 200 or 2000 mg/kg bw of the test substance. Post-exposure period was 14 days.

Result: LD50 = 200 - 2000 mg/kg bw (B6C3F1 -mouse); mortality 0/5 after administration of 200 mg/kg bw mortality, Mortality 5/5 after administration of 2000 mg/kg bw; with 2000 mg/kg bw all mice revealed sedation, apathy and tremor on the same day of application of the test substance

Reference: Bomhard/Groening (Bayer AG), 1990