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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, sufficiently-documented study report, which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

: no details given on the duration of the exposure; no details given on the occlusion made on the application site; dose tested (1710 mg/kg bw) is lower than the recommended limit dose (2000 mg/kg bw); only 7 days postobservation period

GLP compliance:

no

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-(2,4-dimethylphenyl)-3-oxobutyramide]

EC Number:

225-822-9

EC Name:

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

Cas Number:

5102-83-0

IUPAC Name:

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: in house breeding
- Age at study initiation: 8 weeks
- Weight at study initiation: males mean: 322 g; females mean: 210 g
- Housing: single caged
- Diet: pelleted diet (Oakes of Congleton), ad libitum
- Water: ad libitum

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

Administration / exposure

Type of coverage:

not specified

Vehicle:

other: 50:50 mixture: polyethylene glycol/water

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg bw
- For solids, paste formed: yes (1 g of test item was mixed with 2.5 ml of vehicle)

Duration of exposure:

no data

Doses:

9.9 ml of paste per kg bw (equivalent to 3000 mg test item per kg bw)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Remarks on result:

other: corresponds to 1710 mg/kg bw pure Pigment Yellow 13; no animals died within the observation period

Mortality:

- no deaths occurred

Clinical signs:

other: - no clinical symptoms were recorded

Gross pathology:

- No macroscopically visible changes occurred at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

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

Conclusions:

The test item was not toxic to male and female Sprague-Dawley rats after dermal application, resulting in a dermal LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).
The test was performed with the test item which contains relevant amounts of the submission substance. Therefore, the test results are considered adequate to fulfil the endpoint requirements.

Executive summary:

Acute dermal toxicity of the test item was tested in male and female Sprague-Dawley rats. The maximal applicable dose (3 g test item /kg bw suspended in polyethylene glycol:water 50:50 - final volume 9.9 ml; corresponding to 1710 mg PY13/kg bw) were applied to the skin. No clinical signs were observed and no animals died during the 7 day observation period, resulting in a LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw).

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