Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: company guideline similar to OECD Guideline 401
Deviations:
no
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-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide
EC Number:
227-930-1
EC Name:
4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide
Cas Number:
6041-94-7
Molecular formula:
C23H15Cl2N3O2
IUPAC Name:
4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-N-phenyl-2-naphthamide
Test material form:
solid: nanoform, no surface treatment
Details on test material:
Name of test material (as cited in study report): Permanentrot FRR CM 79883
Analytical purity: technically pure

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 84 to 95 g
- Fasting period before study: 16 h
- Housing: grouped, plastic cages
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe, 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: 25 %
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

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 animals died within the observation period
Mortality:
- no deaths occurred
Clinical signs:
other: - no animal showed any clinical symptoms - faeces was red-coloured
Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single application of 15000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw.
Executive summary:

Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 15000 mg/kg bw (25 % suspension in sesame oil). No animal died during the 14 day observation period, resulting in a LD50 >15000 mg/kg bw.