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.

Endpoint summary

Description of key information

Female rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the highest applicable dose of 2000 mg/kg bw. No animals died during the 14 day observation period. At the end of the observation period there were no changes found in necropsy in all animals. Due to this findings the oral LD50 value is > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

reliable

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Value:

>

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

the study does not need to be conducted because inhalation of the substance is likely

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No classification

Neither oral nor inhalation exposure caused adverse effects in rats at the maximum technical doses