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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
o-Phenylenediamine was administered at a single dose to male rats at dose levels of 300, 450, 670, 1000, 1500, 2250, and 3400 mg/kg. oPDA was administered as a suspension in peanut oil or in acetone:peanut oil (1:10).
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): o-Phenylenediamine.
- Purity: > 99%

Test animals

Species:
rat
Strain:
other: ChR-CD
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: Not reported
- Fasting period before study: None
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: peanut oil or acetone:peanut oil (1:10)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10-15%
Doses:
3400, 2250, 1500, 1000, 670, 450, 300 mg/kg
No. of animals per sex per dose:
One per dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology and pathologic changes. Tissues examined histologically included kidney, liver, trachea, lung, brain, testis, bone marrow, spleen, thymus, and gastrointestinal tract.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: ALD
Effect level:
1 500 mg/kg bw
Mortality:
3400 mg/kg - 1 day after dosing.
2250 mg/kg - 2 days after dosing.
1500 mg/kg - 2 days after dosing.
No mortality was observed at 300, 450, 670, or 1000 mg/kg.
Clinical signs:
At Lethal Doses - salivation, tremors, stained ventral area and urine discoloured orange.
Non-Lethal Doses - orange-coloured urine for 1-2 days after dosing at 450 mg/kg and above.
Body weight:
At Lethal Doses - Weight loss
Non-Lethal Doses - Weight loss for 1-4 days at 450 mg/kg and above
Gross pathology:
At Lethal Doses - fatty changes in liver with congestion
Non-Lethal Doses - same as above 14 days after dosing at 1000 mg/kg; none attributable to compound at lower doses 14 days after dosing.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
ALD (rat): 1500 mg/kg
Executive summary:

o-Phenylenediamine was administered at a single dose to male rats at dose levels of 300, 450, 670, 1000, 1500, 2250, and 3400 mg/kg. oPDA was administered as a suspension in peanut oil or in acetone:peanut oil (1:10). Mortality occurred at dose levels of 1500 mg/kg and above. The Approximate Lethal Dose (ALD) was 1500 mg/kg of body weight.