Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 5 JAN 1983 to 19 JAN 1983
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:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.
EC Number:
290-824-9
EC Name:
Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.
Cas Number:
90268-24-9
Molecular formula:
C36H34Cl2N6O4 // C36H33Cl3N6O6 // C36H32Cl4N6O8
IUPAC Name:
2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2,4-dimethylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-N-(2,4-dimethylphenyl)-3-oxobutanamide; N-(4-chloro-2,5-dimethoxyphenyl)-2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(2,4-dimethylphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-3-oxobutanamide; N-(4-chloro-2,5-dimethoxyphenyl)-2-[(1E)-2-{3,3'-dichloro-4'-[(1E)-2-{1-[(4-chloro-2,5-dimethoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl]-[1,1'-biphenyl]-4-yl}diazen-1-yl]-3-oxobutanamide

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil plus emulsifier
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 12,4 % w/w

MAXIMUM DOSE VOLUME APPLIED: 40 ml/kg bw (two times 20 ml/kg bw within 15 minutes)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 550 mg/kg bw
Remarks on result:
other: 5000 mg test item/kg bw correspond to 3550 mg submission substance/kg bw, no animals died within the observation period

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 the limit dose of 5000 mg test substance, corresponding to 3550 mg submission substance per kg bw did not cause lethality in male and female Wistar rats during the 14 days observation period, resulting in a LD50 > 5000 mg/kg bw (thus corresponding to > 3550 mg submission substance/kg bw).
The test was performed with a test substance which contains relevant amounts of the submission substance. Therefore the test results are considered adequat to fulfill the endpoint requirements.
The results of this study are in accordance with the findings presented in the key study.
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 5000 mg/kg bw (corresponding to 3550 mg submission substance/kg bw). No animal died under these conditions, resulting in a LD50 > 5000 mg/kg bw (corresponding to > 3550 mg submission substance/kg bw).

The submission substance has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.