o-phenylenediamine

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:

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

Test material information

Constituent 1

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-Phenylenediamine.
- Purity: > 99%

Test animals

Species:

rat

Strain:

other: ChR-CD

Sex:

male

Details on test animals or test system 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:

other: 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.

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.