Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(o-anisyl and 2,4-xylyl) derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 6 APR 1983 to 20 APR 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 401)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

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

Reference substance name:

Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(o-anisyl and 2,4-xylyl) derivs.

EC Number:

271-878-2

EC Name:

Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(o-anisyl and 2,4-xylyl) derivs.

Cas Number:

68610-86-6

Molecular formula:

C36H34Cl2N6O4 // C35H32Cl2N6O4 // C34H30Cl2N6O6

IUPAC Name:

2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2,4-dimethylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2,4-dimethylphenyl)-3-oxobutanamide; 2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2,4-dimethylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide; 2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: males mean: 186.4 g; females mean: 179.8 g
- Fasting period before study: 16 h
- Housing: in Makrolon cages (Type 4) in groups of 5
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- fully air-conditioned rooms
- Temperature (°C): 22+-2%
- Humidity (%): 45+-5%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 12.5% suspension
MAXIMUM DOSE VOLUME APPLIED: 40 ml/kg bw (applied. 2 x 20 ml)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 850 mg/kg bw

Remarks on result:

other: no animals died within the observation period; 5000 mg/kg bw test item correspond to 2850 mg/kg bw submission substance

Mortality:

- no deaths occured

Clinical signs:

other: - for up to 2 h after application some animals showed an extended palpebral fissure, bristeled fur and exophthalmos - for up to 5 days after application faeces was yellow-coloured

Gross pathology:

observations in animals killed at the end of the observation period:
- 2 male rats: the adrenal gland was darker-coloured
- 3 female rats: the adrenal gland was slightly orange-coloured
- 3 male rats and 2 female rats: no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

Single application of 5000 mg test substance per kg bw (corresponding to 2850 mg submission substance/kg bw) did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 5000 (respectively 2850) mg/kg bw. The test was performed with a test item which contains relevant amounts of the submission substance. Therefore the test results are considered adequat to fulfill the endpoint requirements.

Executive summary:

Male and female Wistar rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the limit dose of 5000 mg/kg bw (corresponding to 2850 mg submission substance/kg bw). No animal died during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw of test substance (respectively 2850 mg submission substance/kg bw).

Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.