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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 16 MAR 1977 to 30 MAR 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
EC Number:
235-462-4
EC Name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
Cas Number:
12236-62-3
Molecular formula:
C17H13ClN6O5
IUPAC Name:
2-[(4-chloro-2-nitrophenyl)diazenyl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide
Test material form:
solid: bulk
Specific details on test material used for the study:
Pigment Orange 36

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 97 -104 g
- Fasting period before study: 16 h before dosing, 2 h after
- Diet: ALTROMIN 1324 (Altroge, Lage, Germany), ad libitum
- Water: tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 %

Doses:
15 000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animal died within the observation period
Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes.
Other findings:
After application animals showed ruffled fur and accelerated respiration. Test substance was excreted via the faeces.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single application of 15000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw.
Executive summary:

Female Wistar rats (n=10) were subjected to test acute oral toxicity. No animal died after single administration of 15000 mg/kg bw of the test substance by gavage (14 day observation period), thus leading to a LD50 > 15000 mg/kg bw.