m-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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Only one animal per dose level.

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

m-phenylenediamine

EC Number:

203-584-7

EC Name:

m-phenylenediamine

Cas Number:

108-45-2

Molecular formula:

C6H8N2

IUPAC Name:

m-phenylenediamine

Details on test material:

Analytical purity: >99%
- Name of test material (as cited in study report): 1,3-Benzenediamine, H-21303
- Physical state: purple to black flake

Test animals

Species:

rat

Strain:

other: Crl:CD BR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, North Carolina
- Age at study initiation: 7 weeks
- Weight at study initiation: 239-297 g
- Housing: individually in suspended stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Rodent Chow #5002 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23± 1°C
- Humidity (%): 50% ± 10%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 7/18/95 To: 8/10/95

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was suspended in deionized water and administered to 1 rat per dose rate by intragastric intubation. Rats were administered doses ranging from 130 to 670 mg/kg-bw in increments of approximately 50%. Additionally, 1 rat was dosed at 2300 mg/kg. The dosing day was test day one; post exposure day 14 was test day 15.

Doses:

Dosage (mg/kg): 130, 200, 300, 450, 670, 2300
Dose vol (mL): 0.18, 0.30, 0.42, 0.61, 0.80, 2.8
Suspension (mg/L): 200, 200, 200, 200, 200, 200

No. of animals per sex per dose:

1 rat per dose level

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Following administration the rats were observed for clinical signs of toxicity. All surviving rats were weighed and observed daily until toxicity subsided up to test day 15.
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

other: Approximate Lethal Dose (ALD)

Effect level:

450 mg/kg bw

Mortality:

The lowest dose of the test substance which resulted in death of a test animal was 450 mg/kg. The rat dosed at 450 mg/kg was found dead by day 2. Deaths also occurred in rats treated at 670 and 2300 mg/kg. The rat treated at 670 mg/kg was found dead 2 days after dosing. The rat treated at 2300 mg/kg was found dead 1 day after dosing.

Clinical signs:

other: NONLETHAL DOSES: Lethargy was observed in the rats treated at 130, 200, and 300 mg/kg approximately 1 hour after dosing. Ruffled fur was observed in rats treated at 200 or 300 mg/kg up to 3 days. LETHAL DOSES: Lethargy was observed in the rats treated at

Gross pathology:

Pathological examinations were not performed.

Any other information on results incl. tables

Dosage (mg/kg)	Dose Volume (mL)	Suspension (mg/mL)	Initial body weight (g)	Mortality
130	0.18	200	272	No
200	0.30	200	297	No
300	0.42	200	282	No
450	0.61	200	273	Yes
670	0.80	200	239	Yes
2300	2.8	200	240	Yes

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of this study, the ALD for the test substance was 450 mg/kg of body weight.

Executive summary:

The test substance was administered as a single oral dose by intragastric intubation to male rats. Rats were found dead up to 2 days after dosing. Clinical signs of toxicity were observed in lethally and nonlethally dosed animals. Under the conditions of this test, the ALD was 450 mg/kg of body weight.