Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 30 NOV 1977 to 20 DEC 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic data given, comparable to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
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-methoxyphenyl)-3-oxobutyramide
EC Number:
236-852-7
EC Name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
Cas Number:
13515-40-7
Molecular formula:
C17H15ClN4O5
IUPAC Name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
Test material form:
solid: nanoform, no surface treatment

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Hoe: WISKf (SPF 71), SPF breeding colony
- Weight at study initiation: mean 182 g
- Fasting period before study: 16 h
- Housing: plastic cages
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, 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% suspension in vehicle



Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animal died within the observation period
Mortality:
- no deaths occurred
Clinical signs:
- no clinical signs of toxicity were observed
- faeces were yellow-coloured in all animals
Body weight:
- body weight development was not impaired
Gross pathology:
- 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:
Criteria used for interpretation of results: EU
Conclusions:
Single application of 5000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.
Executive summary:

Ten female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 5000 mg/kg bw.

No clinical signs of toxicity were observed. Faeces were yellow-coloured in all animals. Body weight development was not impaired. Animals killed at the end of the observation period showed no macroscopically visible changes. No animal died during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.