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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 450 or 2300 mg/kg, and lethargy and partially closed eyes were observed in the rat treated at 670 mg/kg approximately 1 hour after dosing.
Body weight:
A weight loss of approximately 8% of initial body weight was observed in the 200 mg/kg treated rat 1 day after dosing. A combined total of approximately 13% of initial body weight was observed in the 300 mg/kg treated rats by 3 days after dosing. The rat dosed at 450 mg/kg exhibited a weight loss of approximately 5% of initial body weight one day after dosing.
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.