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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Remarks:
for studies; but report not inspected
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate
EC Number:
282-850-4
EC Name:
Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate
Cas Number:
84434-51-5
Molecular formula:
C40H30Cl4N14O20S6.6Na
IUPAC Name:
hexasodium 6,13-dichloro-3,10-bis({[2-({4-chloro-6-[(2,4-disulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)ethyl]amino})-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
Test material form:
other: presscake
Details on test material:
Reactive Blue 198

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 females
5 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: clinical signs multiple times on day one, thereafter twice daily; body weight: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died at 2000 mg/kg
Clinical signs:
other: No significant signs of systemic toxicity observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral lethal dose was tested to be > 2000 mg/kg bw in both male and female rats.
Executive summary:

The test substance was tested for acute oral toxicity in 5 female and 5 female rats per dose group. The test substance was administered as a single dose of 2000 mg/kg bw by gavage after a 16-hour fasting period. The animals were observed for 14 days for signs of toxicity and body weight development.

Surviving rats at the end of the observation period underwent necropsy and macroscopical evaluation.The LD50 was determined to be > 2000 mg/kg bw.