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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:
1971
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:
1971
Report date:
1971

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:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide
EC Number:
229-355-1
EC Name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide
Cas Number:
6486-23-3
Molecular formula:
C16H12Cl2N4O4
IUPAC Name:
2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-chlorophenyl)-3-oxobutanamide
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
- Source: in house breeding, SPF rats
- Weight at study initiation: mean: 104 g (84-118g)
- Fasting period before study: yes, 16 hours
- Diet: Standard ALTROMIN R (Altromin GmbH, Lage/Lippe, Germany)
- Water: tap water

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 12.5%

- the highest concentration (15000 mg/kg bw) was applied in two portions à 7500 mg/kg bw within one hour

Doses:
4000, 6300, 10000, 15000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data, but necropsy of animals which died

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
8 285 mg/kg bw
Based on:
test mat.
Mortality:
4000 mg/kg bw: 0/10
6300 mg/kg bw: 1/10
10000 mg/kg bw: 9/10
15000 mg/kg bw: 10/10

the animals died within 1.5 and 24 hours after application
Clinical signs:
clinical signs of animals which died:
- imbalance, accelerated respiration, prone position, paralysis of the limbs
- the pigment was excreted via faeces
Gross pathology:
- no macroscopic anomalies in the animals

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Single application of the test item to Wistar rats by gavage resulted in an LD50 of 8252 mg/kg bw. The test item has not to be classified for acute oral toxicity.
Executive summary:

Acute toxicity of the test item has been investigated in female SPF-Wistar rats (10 animals per dose group). The animals received 4000, 6300, 10000 or 15000 mg test item / kg bw by gavage (12.5% suspension in sesame oil). The post observation period was 7 days. The mortality was 0/10, 1/10, 9/10 and 10/10 in the 4000, 6300, 10000 or 15000 mg / kg bw dose group. The LD50 was calculated to be 8252 mg/kg bw. Animals which died showed imbalance, accelerated respiration, prone position and paralysis of the limbs. No pathologic findings were observed at necropsy.