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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PK 95/222

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refridgerated

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: Young adult animals
- Weight at study initiation: 150-300 g
- Fasting period before study: 16 h
- Housing: Single housing in fully air-conditioned rooms.
- Diet: ad libitum, Kliba-Labordiaet (Klingentakmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The animals were treated by single gavage after having been fasted for 16 hours.
Doses:
500, 1000 and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Several times on the day of administration, at least once each workday for the individual animal.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.
Statistics:
LD50 values for male and female rats were calculated with the probit model (Finney, 1971).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 000 mg/kg bw
Based on:
test mat.
Mortality:
4 male and all female animals of the 2000 mg/kg bw dose group, 2 male and 4 female rats of the 1000 mg/kg bw dose group died within 2 days after application.
Clinical signs:
Signs of toxicity noted in the 2000, 1000 and 500 mg/kg bw dose groups comprised impaired or poor general state, dyspnoea, apathy, abdominal or lateral position, staggering, ataxia, atonia, paresis, themor, cyanosis and diarrhoea.
Body weight:
Body weight gain was generally observed in the course of the study.
Gross pathology:
Necropsy findings of the animals that died comprised agonal congestion, erythema, parietal edema and erosion/ulcer in the glandular stomach and discoloration of the mucosa of the forestomach and the glandular stomach.
Histopathological examination of the stomach revealed edema of submucosa in the glandular stomach, margo plicatus and at transition to forestomach, mixed-cell infiltration of submucosa and hyperdemia.
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Any other information on results incl. tables

Dose

(mg/kg bw)

Mortality

(Died/Treated)

1 hour

2 hours

3 hours

4 hours

1 day

2 days

14 days

male

female

male

female

male

female

male

female

male

female

male

female

male

female

500

0/5

0/5

0/5

-

-

0/5

0/5

-

0/5

0/5

-

0/5

0/5

0/5

1000

0/5

0/5

0/5

-

-

1/5

0/5

-

2/5

3/5

-

4/5

2/5

4/5

2000

1/5

2/5

2/5

-

-

2/5

3/5

-

4/5

5/5

-

-

4/5

-

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria