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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 February 1995 to 01 March 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recent EU test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
419-480-1
EC Name:
-
IUPAC Name:
Reaction mass of tetrasodium 2-((1-(3-(6-fluoro-(4-((N-(2-(2-sulfatoethanesulfonyl)ethyl)-N-phenyl)amino)-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-) and trisodium 2-((1-(3-((4-(N-(2-ethenesulfonylethyl)-N-phenyl)amino)-6-fluoro-1,3,5-triazin-2-ylamino)-2-hydroxy-5-sulfonatophenylazo)-1-phenylmethyl)azo)-4-sulfonatobenzoate cuprate (4-)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Reactive Blue FC 75311

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winklemann, Borchen, Germany
- Age at study initiation: Males 6 -7 weeks, Females 8 - 9 weeks
- Weight at study initiation: Initial mean weight: Males 180g, Females 161g
- Fasting period before study: 16 hours prior
- Housing: Conventational conditions - Makrolon Typo-III cages, 5 to a cage
- Diet (e.g. ad libitum): Altromin 1324 pellets, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark (artifical light from 6am to 6pm)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Demineralised
Details on oral exposure:
As above; the substance was administered as a single dose of 2000 mg/kg in demineralised water.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Males 5
Females 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Several times on day of administration, twice daily during the observation period (once on weekends & bank holidays)
- 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 animal died during the 14-day observation period.
Clinical signs:
other: Blue discoloration of the feces in correspondence with the color of the dye was observed after single administration of 2000 mg/kg from four hours until the 3rd day following treatment. No other signs of intoxication occurred. All animals were free of
Gross pathology:
None of the animals sacrificed at the end of the 14-day observation period showed any noticeable gross pathological findings.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the present investigations, the test substance is therefore to be regarded as relatively non-toxic.

LD50 > 2000 mg/kg body weight.
Executive summary:

Study conducted to recent EU & OECD test guidance in compliance with GLP.

Based on the present investigations, the test substance is regarded as relatively non-toxic and is not classified.

LD50 > 2000 mg/kg body weight.