Registration Dossier
Registration Dossier
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EC number: 219-746-5 | CAS number: 2519-30-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
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:
- 1 967
- 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
- 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
- Remarks:
- migrated information: 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%
Constituent 1
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 availableENVIRONMENTAL CONDITIONS- Temperature (°C): No data available- Humidity (%):No data available- Air changes (per hr): No data available- Photoperiod (hrs dark / hrs light): No data availableIN-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:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- 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:
Acute toxicity test was performed on mice at concentration of 2000 mg/kg and observed for 14 days.10 mice/sex were used. The LD50values with 95 % confidence limits were calculated according to Litchfield & Wilcoxon. No toxic signs or deaths were observed during study.
Therefore, the LD 50 value of Brilliant Black PN was found to be >2000 mg/kg for mice.
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