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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1974
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:
1974

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:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-
EC Number:
268-655-7
EC Name:
Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-
Cas Number:
68132-91-2
Molecular formula:
C38H20Cl2CuN14O18S5. H. 5Na C38H21Cl2CuN14Na5O18S5
IUPAC Name:
Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-
Test material form:
solid: particulate/powder
Details on test material:
Test Substance : Procion Blue H-E RD = Reactive Blue 160

Test animals

Species:
rat
Strain:
other: Alderley Park SPF Albino strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Zeneca Alderley Park
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Weight at study initiation: ca. 150 g
- Fasting period before study: 16 hours prior to dosing
- Housing: group housing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE: Water
- Concentration in vehicle: 20% and 40%
- Amount of vehicle (if gavage): 10 mL/Kg bw
- Justification for choice of vehicle: water soluble dye


MAXIMUM DOSE VOLUME APPLIED: 10 mL/Kg
Doses:
2000 and 4000 mg/Kg bw
No. of animals per sex per dose:
3 males + 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology of iver, kidney, heart, adrenals, gonads, stomach, spleen, thymus and lung in some animals

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 848 mg/kg bw
Based on:
act. ingr.
Mortality:
none
Clinical signs:
2000 mg/Kg: none
4000 mg/Kg: Slight piloerection, hunched posture

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 is higher than 4000 mg/Kg bw