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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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 30 Oct 1980 to 13 Nov 1980
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:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
no (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-phenyl-3H-pyrazol-3-one]
EC Number:
222-530-3
EC Name:
4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one]
Cas Number:
3520-72-7
Molecular formula:
C32H24Cl2N8O2
IUPAC Name:
4,4'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(5-methyl-2-phenyl-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: 200-210 g
- Fasting period before study: 16 h before and 2 h after dosing
- Housing: in groups
- Diet (ad libitum): Altromin 1324 (Altromin, Lage/Lippe, Germany)
- Water (ad libitum): tap water

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg as 25% aqueous suspension
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:
> 2 100 mg/kg bw
Based on:
other: submission substance
Remarks on result:
other: The test item contained 42% of the submission substance, i.e. 5000 mg test item/kg bw applied correspond to 2100 mg submission substance/kg bw. resulting in a LD50 of >2100 mg/kg bw.
Mortality:
no deaths
Clinical signs:
other: no treatment-related effects
Gross pathology:
no treatment-related effects
Other findings:
no treatment-related effects

Any other information on results incl. tables

No signs of intoxication were observed, macroscopic examination revealed no effects

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 > 5000 mg test item/kg bw (>2100 mg submission substance/kg bw).
Executive summary:

Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage in doses of 5000 mg/kg bw.. No animal died during the 14 day observation period, resulting in a LD50 >5000 mg test item/kg bw, corresponding to a LD50 >2100 mg/kg bw submission substance. No further toxic effects were observed.