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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1979-10-25 to 1979-11-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Internal Guideline Hoechst AG
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
EC Number:
263-856-6
EC Name:
Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
Cas Number:
63105-49-7
Molecular formula:
C20H14CuN3O15S4.3Na C20H14CuN3Na3O15S4
IUPAC Name:
trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Hoe WISKf(SPF71)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in house
- Weight at study initiation: 160 - 176g (mean = 168.8 g, s = +/- 6.3 g, n = 20)
- Fasting period before study: 16h before application until 2h after application no feeding
- Housing: in groups
- Diet (e.g. ad libitum): ALTROMIN 1324, ad libitum
- Water (e.g. ad libitum): mains water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
demineralized
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% test substance in demineralized water (substance is well soluble in water)
Doses:
3150 and 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
- Frequency of observations and weighing: weakly weighing during the observation time of 14days
- 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.
Mortality:
4 of 10 animal died in the highest dose of 5000 mg/kg bw within 1-3 days after application
Clinical signs:
passivity, vestibular disorder, crouched position, hair-raising, straitened lid slit, violet coloured feces and urine, diarrhea, violet coloured skin where hairless
Gross pathology:
in dead animals: gastro-intestinal system filled with test substance; all organs, including muscle and fat tissue, coloured

Any other information on results incl. tables

dose

[mg/kg bw] 

 concentration

[%]

  dead animals/treated animals
 3150  25  0/10
 5000  25  4/10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for oral toxicity to femal rats was determined to be > 5000 mg/kg bw. The substance is not classifiable according to CLP criteria