Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 22,1983 to July 06,1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant with international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium

EC Number:

291-103-1

EC Name:

Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium

Cas Number:

90341-71-2

Molecular formula:

C22H14CuN4Na4O15S4

IUPAC Name:

Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Remazol Brillantblau BB

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: male 179 g , female 187 g
- Housing: 5 rats/cage in Macrolon cages type IV
- Fasting period before study: 16 hrs before the treatment and 2 hrs after
- Diet : Rattendiät Altromin 1324 , ad libitum
- Water : ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%):55 ± 10 %
- Photoperiod : 12 hrs cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

demineralized

Details on oral exposure:

Concentration 25% (w/v) in water
Dose: 5000 mg/kg bw
Apllication volume: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: yes , once a week
- Frequency of clinical observations: multiple times on Day 1, twice daily thereafter
- Necropsy of survivors performed: yes

Statistics:

NA

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mL/kg bw

Based on:

test mat.

Mortality:

One female died within 3 hours after dosing. As the lung was bluish discolored, it may be that part of the test substance was aspirated during gavage.

Clinical signs:

other: Day 1: Males + females: Reduced activity, pale skin; from 2 hours onwards bluish discolored skin; bluish discolored feces on Day 1 and 2 Females: From 2 hours until end of Day 1 hunched posture; one animal showed narrowed eyelids

Gross pathology:

death female: blue liquid in GIT; lung patrially bluish discolored; skin light bluish discolored
One male: lung reddish discolored
All other rats were without abnormal findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance Remazol Brilliantblau is considered non toxic by oral administration.

Executive summary:

Remazol Brilliant Blue BB has been tested in male and female Wistar rats at a limit dose of 5000 mg/kg bw. The results shows a medium lethal dose (LD₅₀) of above 5000 mg/kg body weight in male and female rats.