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]

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: After dosing the animals showed ruffled fur and crouched posture

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.