Reaction products of diazotised m-phenylendiamine, subsequently coupled with diazotised 4-aminobenzene-1-sulfonic acid, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Since February 11,1986 to February 25,1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: EC Directive 84/449 (Official Journal of the European Communities 27, 1984, L 251, 96).

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Direct Brown 44

IUPAC Name:

Direct Brown 44

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Winkelmann
- Age at study initiation: males 9 weeks , females 14 weeks
- Weight at study initiation: males 155-170, females 171-178 g.
- Housing:The rats were conventionally housed in cages Makrolon type III with chip wood pellets , 5 rats for each cage
- Fasting period before study:no, the was wasn't available approximately 16 hours before until 4 hours after application
- Diet: Altromin R 1324 ad libitum
- Water : tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 2 ° C
- Humidity (%): 50 ± 10%
- Photoperiod : 12 hours cycle dark/light from 6 AM to 18 CET PM

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:20 ml / kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 animals x sex x single dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice a day
- Necropsy of survivors performed:yes with diethyl ether
- Other examinations performed: clinical signs,

Upon application and at the end of the 14-day observation period the surviving animals were weighed individually.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 600 mg/kg bw

Based on:

act. ingr.

Mortality:

no mortality observed

Clinical signs:

other: no signs observed

Gross pathology:

no pathology observed

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 for Direct Brown 44 is greater then 5000 mg/kg bw (LD50 > 3600 mg/kg bw based on active ingredient). No signs of toxicity was observed

Executive summary:

Direct Brown 44 was tested for acute toxicity with oral administration on male and female Wistar rats. The LD50 for male and female rats was greater than 5000 mg / kg body weight. There were no signs of toxicity.