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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 29 APR 1992 to 13 MAY 1992

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:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

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(p-anisyl and Ph) derivs.

EC Number:

290-823-3

EC Name:

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

Cas Number:

90268-23-8

Molecular formula:

C32H26Cl2N6O4 // C33H28Cl2N6O5 // C34H30Cl2N6O6

IUPAC Name:

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

Test material form:

solid: nanoform

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: male: approx. 7 weeks; female: approx. 8 weeks
- Weight at study initiation: males mean: 202 g; females mean: 185 g
- Fasting period before study: yes (no further information)
- Housing: in Makrolon cages (Type 4) in groups of 5
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: approx. 5 days


ENVIRONMENTAL CONDITIONS
- fully air-conditioned rooms
- Temperature (°C): 22+-3%
- Humidity (%): 55+-20%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

- no further information

Doses:

limit dose: 2000 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 weighing: weekly
- Frequency of observations: twice every day/weekends and holidays only once
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no animals died within the observation period

Mortality:

- no deaths occured

Clinical signs:

other: - no signs of toxicity observed - faeces was yellow- coloured in all animals from day 2 to day 5

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:

Criteria used for interpretation of results: other: CLP regulation

Conclusions:

Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in male and female Wistar rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

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 2000 mg/kg bw: No animal died during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.

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