Registration Dossier
Registration Dossier
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EC number: 202-430-6 | CAS number: 95-54-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report, which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: internal company guideline similar to OECD 401
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- o-phenylenediamine
- EC Number:
- 202-430-6
- EC Name:
- o-phenylenediamine
- Cas Number:
- 95-54-5
- Molecular formula:
- C6H8N2
- IUPAC Name:
- benzene-1,2-diamine
- Details on test material:
- - Name of test material (as cited in study report): o-Phenylendiamin
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: SPF-Wistar-K-Rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation:
male: 80-96 g (average 85 g).
female: 80-132 g (average 93 g)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: starch solution
- Details on oral exposure:
- single dose by oral gavage
- Doses:
- concentration: 10%
male
800 mg/kg bw
1000 mg/kg bw
1250 mg/kg bw
1600 mg/kg bw
2000 mg/kg bw
female
630 mg/kg bw
1000 mg/kg bw
1250 mg/kg bw
1600 mg/kg bw
2000 mg/kg bw
2500 mg/kg bw - No. of animals per sex per dose:
- 10 rats per sex and dose
- Control animals:
- no
- Details on study design:
- Food was withheld 16 hours before treatment.
The duration of the observation period was 7 days.
Food: Standard-ALTROMIN from Altromin GmbH Lage/Lippe, tap water - Statistics:
- LD 50 was calculated according to the method of KÄRBER.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 418 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 365 mg/kg bw
- Based on:
- test mat.
- Mortality:
- male
800 mg/kg bw: 0 of 10
1000 mg/kg bw: 0 of 10
1250 mg/kg bw: 4 of 10
1600 mg/kg bw: 7 of 10
2000 mg/kg bw: 10 of 10
female
630 mg/kg bw: 0 of 10
1000 mg/kg bw: 0 of 10
1250 mg/kg bw: 6 of 10
1600 mg/kg bw: 8 of 10
2000 mg/kg bw: 9 of 10
2500 mg/kg bw: 10 of 10 - Clinical signs:
- other: Lethally intoxicated animals: disturbance of equilibrium, prone position, lateral position, at 2500 mg/kg bw: convulsions, increased breathing rate
- Gross pathology:
- no abnormal findings
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50 male: 1418 mg/kg bw
LD50 female: 1365 mg/kg bw - Executive summary:
LD50 male: 1418 mg/kg bw, LD50 female: 1365 mg/kg bw
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