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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:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (e.g. only 7 days post observation period, no details on body weight development)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: only 7 days of observation p.a.; details on body weight development are missing
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]
EC Number:
226-789-3
EC Name:
2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]
Cas Number:
5468-75-7
Molecular formula:
C34H30Cl2N6O4
IUPAC Name:
2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(2-methylphenyl)-3-oxobutanamide]
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Tif. RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: SPF in-house breeding colony
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180g
- Fasting period before study: one night before treatment
- Housing: caged in Macrolon cages (type 3) in groups of five (male and female separately)
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% suspension in 2% CMC

Doses:
6000 and 10000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Remarks on result:
other: no animals died within the observation period

Any other information on results incl. tables

- within 2 hours after treatment, all treated animals showed dyspnoea, exophthalmus, curved position and ruffled fur

- in the higher dose (10 g/kg bw) these symptoms became more accentuated

- all animals recovered within 3 to 6 days

- animals were sacrificed at day 7, but no substance related gross organ changes were seen

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 different dose levels ( up to 10 g/kg bw) of the test substance did not cause lethality in male and female Tif. RAI rats during the 7 day observation period, resulting in a LD50 > 10000 mg/kg bw.
Executive summary:

Male and female Tif. RAI rats were subjected to test acute oral toxicity. The test substance was administered by gavage at dose levels up to the highest applicable dose of 10000 mg/kg bw. No animal died under these conditions, thus leading to a LD50 > 10000 mg/kg bw. No substance related gross organ changes were seen at necropsy.

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

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