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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
Study period:
Feb 1980 to Mar 1980
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:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
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
- Name of test substance as cited in report: Neozapon-orange Vers. 1187 (pulvrig)
- Substance number as cited in report: 79-594

FORM AS APPLIED IN THE TEST
Suspension

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Wiga
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males, 170-190 g; females: 160-170 g
- Fasting period before study: 15 to 20 hours
- Diet: Herilan MRH-Haltung; H Eggersmann KG

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle (%, g/v): from low to high dose: 16.5; 24.2; 35.6; 35.6; 35.6
- Amount of vehicle (mL/kg): from low to high dose: 5.0; 5.0; 5.0; 7.3; 10.8

MAXIMUM DOSE VOLUME APPLIED:
10.8 mL/kg
Doses:
825; 1210; 1780; 2610; 3830 mg/kg
No. of animals per sex per dose:
5, except for the 2610 mg/kg dose in males which was tested in 4 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: < 15min, 15 min, 30 min, 1 hour, 4 hours, 1 day, 2 days, 5 days, 6 days, 7 days, 8 days, 9 days, 12 days, 13 days, 14 days
- Frequency of weighing: 2-4, 7 and 13 days
- 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:
LD50
Effect level:
1 400 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
1 200 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
Based on:
test mat.
Mortality:
- 825 mg/kg: no mortality was observed
- 1210 mg/kg: males, 3 animals died after 7 days; females, 3 animals died after 7 days
- 1780 mg/kg: males, 1 animal died after 7 days; females, 4 animals died after 7 days
- 2610 mg/kg: males, 4 (all) animals died after 7 days; females, 5 (all) animals died after 7 days
- 3830 mg/kg: males, 5 (all) animals died after 7 days; females, 5 (all) animals died after 7 days
Clinical signs:
- 825 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea
- 1210 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea
- 1780 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea
- 2610 mg/kg: Observed symptoms included orange faeces, orange urine, diarrhoea, dyspnoea, apathy, stagger, worse general condition
- 3830 mg/kg: Observed symptoms included orange urine, diarrhoea
Body weight:
No treatment-related effects observed
Gross pathology:
- Animals that died during the study: heart, acute dilation of the atria; acute hyperaemia; organs/adipose tissue/musculature: substance stained.
- Sacrificed animals: no effects observed

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria