Reaction products of diazotised sodium 2-amino-5-{[2-(sulfonatooxy)ethyl]sulfonyl}benzenesulfonate coupled with sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate, subsequently coupled with diazotised sodium 2-(4-aminobenzene-1-sulfonyl)ethyl sulfate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Data is from publication

Data source

Reference

Reference Type:

publication

Title:

Acute (Mouse and Rat) and Short-term (Rat) Toxicity Studies on Black PN

Author:

I.F. Gaunt, Madge Farmer, P. Grasso, S.D. Gangolli

Year:

1967

Bibliographic source:

Food and Cosmetics Toxicology Volume 5, 1967, Pages 171-177

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as per mentioned below

Principles of method if other than guideline:

Oral dosages of compound were administered by oral intubation to the mouse. Animals were observed usually for 14 days during which time the development of toxic signs was followed and time of death recorded.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

EC Number:

219-746-5

EC Name:

Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate

Cas Number:

2519-30-4

Molecular formula:

C28H21N5O14S4.4Na

IUPAC Name:

tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Brilliant Black PN
- Molecular formula (if other than submission substance): C28H17N5Na4O14S4
- Molecular weight (if other than submission substance):867.66716 g\mol
- Substance type: Organic
- Physical state: Solid
-Purity:83.6%

Specific details on test material used for the study:

- Name of test material (as cited in study report): Brilliant Black PN
- Molecular formula (if other than submission substance): C28H17N5Na4O14S4
- Molecular weight (if other than submission substance):867.66716 g\mol
- Substance type: Organic
- Physical state: Solid
-Purity:83.6%

Test animals

Species:

mouse

Strain:

other: ICI Alderley Park Strain 1 SPF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: 18 hr prior to dosing
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

No data available

Doses:

no data

No. of animals per sex per dose:

10 mice/sex

Control animals:

yes

Details on study design:

no data available

Statistics:

LD50 values with 95 % confidence limits were calculated according to Litchfield & Wllcoxon (1949).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: with 95 %confidence limits

Mortality:

No mortality observed

Clinical signs:

other: no toxic signs observed

Gross pathology:

No data available

Other findings:

Orally, a substantial amount of coloured material was excreted in the faeces.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

In acute toxicity study by oral route the LD50 value for the Brilliant Black PN was found to be >2000 mg/kg for mice

Executive summary:

An acute oral toxicity study was performed to access the toxicity potential of the read across substance Brilliant Black PN (CAS no. 2519-30-4, E.C. no.: 219-746-5. The test substance was administered in 10 male and female mice of ICI Alderley Park Strain 1 SPF strain via oral route. The test substance was administered at a dose of 2000mg/kg. The treated animals were further observed for clinical signs of toxicity and mortality. The LD50 value with 95% confidence limits were calculated according to LItchfield & Wilcoxon. No clinical signs of toxicity or mortality was observed in any of the animal at the dose of 2000mg/kg. Therefore, the LD 50 value of Brilliant Black PN was found to be >2000 mg/kg for mice. Hence, the test substance was considered to be "not classified", as per the CLP criteria.