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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

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

Data source

Reference
Reference Type:
study report
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)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.
EC Number:
277-257-2
EC Name:
Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.
Cas Number:
73049-92-0
Molecular formula:
not applicable
IUPAC Name:
Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Reactive Blue 21

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- rats Hoe WISKf(SPF71)
- Weight at study initiation: 160 - 178 g
- Fasting period before study:16 hours before gavage application and 2 hours after
- Housing: in macrolon cages on soft wood granulate
- Diet : Altromin 1324 rat diet, ad libitum
- Water : ad libitum

Start of study: November 26, 1979
End of study: December 10, 1979

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: starch/water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: multiple times on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes
Statistics:
-

Results and discussion

Preliminary study:
NA
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
no deaths
Clinical signs:
no clinical signs
Body weight:
no effects
Gross pathology:
no effects
Other findings:
kidney cortex discoloured turquoise

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral medial lethal dose is above 5000 mg/kg bw in female Hoe:WISKf(SPF71) rats