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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, reduced, oxidized, potassium sodium salts
EC Number:
290-714-0
EC Name:
Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, reduced, oxidized, potassium sodium salts
Cas Number:
90218-39-6
Molecular formula:
C38H24N8Na4O12S4
IUPAC Name:
tetrasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
Test material form:
solid
Details on test material:
Direct Orange 57

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Strain Wistar II
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 150 - 200g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 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
Statistics:
Probit-Analysis

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:
not determinable due to absence of adverse toxic effects
Mortality:
no mortality
Clinical signs:
other: no clinical signs

Any other information on results incl. tables

 dose

[g/kg bw]

 dead animals/treated animals
 5.0  0/ 10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) for female rats was determined to be >5000 mg/kg bw under the conditions of the test. The substance is not classifiable according to CLP criteria.