REACTIVE BLUE FC 75311

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

Test guideline 2

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

Test material information

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.