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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:
1-29 March 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Instead of 5 rats/sex/group, 10 females/group were used.
GLP compliance:
no
Remarks:
did not exist at that time
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monochloressigsaure VM 2308

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1%
MAXIMUM DOSE VOLUME APPLIED: max 16 ml/kg
Doses:
40 mg/kg
63 mg/kg
100 mg/kg
160 mg/kg
No. of animals per sex per dose:
10 females/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly weighing and no data on observation scheme
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
90.4 mg/kg bw
Based on:
test mat.
95% CL:
73.6 - 112
Mortality:
40 mg/kg 0/10
63 mg/kg 2/10
100 mg/kg 5/10
160 mg/kg 10/10
Clinical signs:
Animals which died during study: restless behaviour, uncoordinated movements, hunched posture, lethargy, lacrimation, piloerection, pulsing respiration.
Surviving animals showed these symptoms at lower severity and recovered from all symptoms within 48 h after dosing.
Body weight:
Normal
Gross pathology:
Surviving animals: no findings
Animals which died during the study showed red-brown and highly vascularised liver with patch pattern, red-pink lungs with foci. Spleen was black discolored at the stomach-side.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Oral LD50= 90.4 mg/kg