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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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.

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