A mixture of: N-(4-chlorophenyl)-4-(2,5-dichloro-4-(dimethylsulfamoyl)phenylazo)-3-hydroxy-2-naphthalenecarboxamide; N-(4-chlorophenyl)-4-(2,5-dichloro-4-(methylsulfamoyl)phenylazo)-3-hydroxy-2-naphthalenecarboxamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 9 weeks, females: 11 weeks
- Weight at study initiation: males: 188 - 197 g, females: 170 - 182 g
- Fasting period before study: 12 to 18 hours
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, rat maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

VEHICLE
- Application Volume / kg body weight: 10 ml at 2000 mg/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: 2000 mg/kg: males - breathing: rales (1), males - no clinical signs (4) females - no clinical signs (5)

Gross pathology:

2000 mg/kg:

dead: lungs: discoloration, pale (1)

sacrificed: lungs: discoloration, dark red (1)
no macroscopical organ changes (8)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 > 2000 mg/kg bw
The test item is not subject to classification and labelling.

Executive summary:

In accordance with OECD TG 401 the test article was administered to rats of both sexes by oral gavage, at a single dose of 2000 mg/kg.

DEATH RATE:

10% at 2000 mg/kg (i.e. 1/10).

CLINICAL SIGNS:

males:

- breathing: rales (1)

- no clinical signs (4)

females

- no clinical signs (5)

The male animal had recovered after 2 observation days.

BODY WEIGHTS:

The body weight gain of the animals was not affected by the test article treatment throughout the entire study period.

MACROSCOPICAL FINDINGS:

dead:

- lungs: discoloration, pale (1)

sacrificed:

- lungs: discoloration, dark red (1)

- no macroscopical organ changes were observed (8)