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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:
From 16 Mar 1977 to 30 Mar 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:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]
EC Number:
239-898-6
EC Name:
4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]
Cas Number:
15793-73-4
Molecular formula:
C34H28Cl2N8O2
IUPAC Name:
4,4'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[5-methyl-2-(4-methylphenyl)-2,4-dihydro-3H-pyrazol-3-one]
Test material form:
solid: nanoform

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 97-107 g
- Fasting period before study: 16 h before and 2 h after dosing
- Diet (ad libitum): Altromin 1324 (Altromin, Lage/Lippe, Germany)
- Water (ad libitum): tap water


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
15000 mg/kg bw as 25% suspension in sesame oil
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 observations and weighing: observations performed, but not stated in detail; weighing was performed weekly
- Necropsy of survivors performed: yes (macroscopic examination)
Statistics:
not performed

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animal died after gavage of the highest applicable dose
Mortality:
no deaths
Clinical signs:
After dosing the animals showed ruffled fur and crouched posture
Body weight:
no treatment-related effects
Gross pathology:
no treatment-related effects
Other findings:
The coloured test item was excreted in faeces

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the LD50 was > 15000 mg/kg bw in female rats.
Executive summary:

Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage in doses of 15000 mg/kg bw. After dosing the animals showed ruffled fur and crouched posture. No animal died during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw. Necroscopy revealed no macroscopic organ alterations.

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