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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:
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:
1971
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

Constituent 1
Chemical structure
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

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:
Lethally intoxicated animals: disturbance of equilibrium, prone position, lateral position, at 2500 mg/kg bw: convulsions, increased breathing rate
Body weight:
no data
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