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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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation is insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; different volumes applied, reporting deficiencies concerning housing, body weights, signs of toxicity
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: no data
- Name of test material (as cited in study report): o-Chloranilin
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
other: Wistar-II
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann
- Weight at study initiation: 160-180 g
- Housing: 5 per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.6 mL/ kg

Doses:
0.5, 0.7, 0.9, 1.0, 1.6 ml/kg body weight
No. of animals per sex per dose:
10 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of dosing every hour and once a day thereafter until day 7 post application and then again on day 14
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
The LD50 was calculated by the method of Fink and Hund (1965)

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 016 mg/kg bw
95% CL:
883 - 1 186
Remarks on result:
other: density 1.21 mg/ cm³; no constant volumes applied
Mortality:
0.5 mL (605 mg)/ kg /bw: 0/10
0.7 mL (847 mg)/ kg /bw: 4/10; 3h-2d post-application
0.9 mL (1089 mg)/ kg /bw: 6/10; 2d post-application
1.0 mL (1210 mg)/ kg /bw: 6/10; 3h-2d post-application
1.6 mL (1936 mg)/ kg /bw: 6/10; 1h-2d post-application
Clinical signs:
0.5 mL (605 mg)/ kg /bw: sedation, convulsion, chromodakryorrhoe
0.7 mL (847 mg)/ kg /bw: sedation, convulsion
0.9 mL (1089 mg)/ kg /bw: sedation, convulsion, chromodakryorrhoe
1.0 mL (1210 mg)/ kg /bw: sedation, convulsion, face down position
1.6 mL (1936 mg)/ kg /bw: very poor condition, sedation, convulsion, face down position
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion