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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifc 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

Principles of method if other than guideline:
5 male + female rats and 5 male + female mice received a single intraperitoneal application of 100, 200, 400 mg/kg bw (mice) or 1000 mg/kg bw (rats) of the test substance. Post-exposure period was 14 days.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity 99.1%; density: 1.035 g/ml

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
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, single cage for mice.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
physiological saline
Details on exposure:
constant application volume (2 ml/kg bw)
Doses:
100, 200, 400 mg/kg bw
No. of animals per sex per dose:
5 male + 5 female mice
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 weekens) 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, pathology
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 400 mg/kg bw
Mortality:
Male mice: dose 100 mg/kg bw, mortality 1/5; dose 200 mg/kg bw, mortality 0/5; dose 400 mg/kg bw, mortality 2/5
Female mice: dose 100 mg/kg bw, mortality 0/5; dose 200 mg/kg bw, mortality 1/5; dose 400 mg/kg bw, mortality 3/5
Clinical signs:
A dose of 200 or 400 mg/kg bw caused sedation, worse general condition and lateral condition
Body weight:
Avarage body weight gain was not significantly influenced
Gross pathology:
Animals which died during experiment reveald mainly changes of the mucosa of the stomach and intestine. The liver was pale and of weak consistence. Additionally animals which died after a dose of 400 mg/kg bw revealed pale kidneys. Male and female mice killed at the end of the experiment werewithout pathological findings.
Other findings:
No data

Any other information on results incl. tables

By means of this study it should be clarified if the differences in the oral toxicity of the test substance in different animals species (rat and mouse) is caused by a different enteral resorption of the substance.

Applicant's summary and conclusion

Executive summary:

Method: 5 male + female rats and 5 male + female mice received a single intraperitoneal application of 100, 200, 400 mg/kg bw (mice) or 1000 mg/kg bw (rats) of the test substance. Post-exposure period was 14 days.

Result: LD50 = ca. 400 mg/kg bw (mouse, male + female)

Reference: Bomhard (Bayer AG), 1990

Remark: Aim of the study was to clarify if a different resorption rate of the test substance is the cause for differences in the oral toxicity of the test substance in mice and rats. the difference of oral toxicity of the test substance in mice and rats is also present by intraperitoneal application. therefore different resorption rats can be excluded as the reason for unequal toxicity of the test substance in mice and rats.