N-(4-chloro-2,5-dimethoxyphenyl)-2-[[2,5-dimethoxy-4-[(phenylamino)sulphonyl]phenyl]azo]-3-oxobutyramide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

From 29 SEP 1976 to 13 OCT 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic data given, comparable to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

no

Remarks:

study was performed previous to GLP implementation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide

EC Number:

219-730-8

EC Name:

2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide

Cas Number:

2512-29-0

IUPAC Name:

2-[(4-methyl-2-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Hoe: WISKf (SPF 71), SPF breeding colony
- Weight at study initiation: mean 97 g
- Fasting period before study: 16 h
- Housing: plastic cages
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany) ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% suspension in vehicle

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no animal died within the observation period

Mortality:

- no deaths occurred

Clinical signs:

other: - no clinical signs of toxicity were observed - faeces was yellow-coloured in all animals

Gross pathology:

- animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single application of 10000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 10000 mg/kg bw.

Executive summary:

Ten female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 10000 mg/kg bw. No animal died during the 14 day observation period, resulting in a LD50 >10000 mg/kg bw.