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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:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
adopted 1984
Deviations:
yes
Remarks:
modified according to BGA-modell: "Neue Wege zur Bestimmung der akuten Toxizitaet von Chemikalien" (1991)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr . K . Thomae GmbH, D-W7950 Biberach, FRG
- Age at study initiation: young adult
- Weight at study initiation: 176-190g
- Fasting period before study: >=16h (water ad lib.)
- Housing: individually in stainless steel wire mesh cages, type DK-III
- Diet (e.g. ad libitum): Kliba diet 343 ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: >= 1 week

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 or 20g/100ml
- Amount of vehicle (if gavage): 10ml/kg b.w.
- Justification for choice of vehicle: physiological

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 2000mg/kg b.w. was selected because no toxicity was expected based on physical and chemical characteristics of the test substance.
Doses:
200 mg/kg bw
2000 mg/kg bw
No. of animals per sex per dose:
3 females, 3 males (200 mg/kg)
3 females (2000 mg/kg)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: serveral times on day one, at least once daily thereafter
weighing: once before application, weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
200 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD100
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
200 mg/kg: no deaths
2000 mg/kg: all animals died within 4-24h
Clinical signs:
200 mg/kg: no symptoms
2000 mg/kg: poor general state, dyspnoea, apathy, abdominal position, atonia, paresis, cyanosis, diarrhea
Body weight:
200 mg/kg: no effects
2000 mg/kg: no effects
Gross pathology:
200 mg/kg: no effects
2000 mg/kg: general congestion

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the conditions of this study, the LD50 was found to be greater than 200 mg/kg and less than 2000 mg/kg bw.
Executive summary:

A group of 6 fasted animals (3 males and 3 females) was given a single oral dose of test material preparation in aqua bidest at the dose level of 200 mg/kg bw. Another group of 3 females was treated in the same way with a dose of 2000 mg/kg bw.

The animals treated with 200 mg/kg bw did not show any mortality or symptoms. No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Signs of toxicity noted in females treated with 2000 mg/kg bw comprised poor general state, dyspnea, apathy, abdominal position, atonia, paresis, cyanosis and diarrhea. All females treated with 2000 mg/kg bw died 4 hours or 1 day after treatment. Necropsy findings of the animals that died was general congestion.

Under the conditions of this study, the range of LD50 after oral application was found to be greater than 200 mg/kg bw and less than 2000 mg/kg bw.