2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methylphenyl)-3-oxobutyramide]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 13 SEP 1979 to 27 SEP 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methylphenyl)-3-oxobutyramide]

EC Number:

228-771-0

EC Name:

2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-methylphenyl)-3-oxobutyramide]

Cas Number:

6358-37-8

Molecular formula:

C34H30Cl2N6O4

IUPAC Name:

2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(4-methylphenyl)-3-oxobutanamide]

Test animals

Species:

rat

Strain:

other: RAI f (SPF) (Ra 25)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF breeding colony
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: male mean: 202 g, female mean: 177 g
- Fasting period before study: 18 h
- Housing: single caged
- Diet: Labsure CRM (X) Expanded diet, ad libitum
- Water: water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:

10 ml/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
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Remarks on result:

other: no animals died within the observation period; 10 mL test substance/kg bw corresponds to about 3500 mg Pigment Yellow 55/kg bw

Mortality:

- no deaths occurred

Clinical signs:

other: - urine and faeces were yellow-coloured at 21 hours post application - no abnormalities were noted after day 2 or at terminal autopsy

Gross pathology:

- the 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: other: CLP regulation

Conclusions:

Single application of 10 ml test substance, corresponding to about 3500 mg Pigment Yellow 55 per kg bw, did not cause lethality in male and female rats, resulting in a LD50 > 10 ml/kg bw (thus corresponding to about 3500 mg Pigment/kg bw).
The test was performed with a test substance which contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.

Executive summary:

Male and female RAI rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the limit dose of 10 ml /kg bw (corresponding to about 3500 mg Pigment Yellow 55/kg bw). No animal died under these conditions, resulting in a LD50 > 10 ml/kg bw (thus corresponding to about 3500 mg Pigment Yellow 55/kg bw).

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