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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 26 MAY 1981 to 09 JUN 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
EC Number:
278-770-4
EC Name:
2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
Cas Number:
77804-81-0
Molecular formula:
C36H32N10O8
IUPAC Name:
2,2'-[Ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide
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
- Source: in-house breeding colony
- Weight at study initiation:168 - 179 g
- Fasting period before study: 16 h before dosing, 2 h after
- Housing: in groups
- Diet: ALTROMIN 1324 (Altroge, Lage, 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: 5 % suspension in sesame oil
Doses:
5 000 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 observations and 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
Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes
Other findings:
The following effects were observed after administration of test substance: hair raising, diarrhea, yellow coloured faeces. 72 h after application animals were free of any symtoms.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Single application of 5000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.
Executive summary:

Female Wistar rats were subjected to test acute oral toxicity. 5000 mg/kg bw of the test substance were administered by gavage. No animal died under these conditions during the 14 -day observation period, thus leading to a LD50 > 5000 mg/kg bw.