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Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-6-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-7-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate
EC number: 911-640-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Scientific Opinion on the re-evaluation of Brillant Black BN (E151) as food additive
- Author:
- EFSA panel of Food Additives and Nutrient Sources added to Food (ANS)
- Year:
- 2 010
- Bibliographic source:
- EFSA
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Pregnant SPF derived Wistar rats distributed in groups of 30 animals were gavage-fed at dose levels of 0, 250, 500 or 2500 mg/kg bw /day from day 0-19 of pregnancy.
- GLP compliance:
- not specified
- Limit test:
- no
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:
- Food Black 1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- daily
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 0-19 of pregnancy
- Frequency of treatment:
- daily
- Duration of test:
- 21 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,250, 500 and 2500 mg/kg bw /day
Basis:
actual ingested
- No. of animals per sex per dose:
- 30 pregnant females per each dose
- Control animals:
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- No abnormalities in condition or behaviour of the dams were observed.
- Ovaries and uterine content:
- On day 21, the animals were killed and ovaries and uterus removed. The number of corpora lutea and the number and position of implantation sites were recorded. Live foetuses, embryonic and foetal resorptions, and dead foetuses were counted
- Fetal examinations:
- Half the foetuses in the control and top dose groups were examined for skeletal malformations and the other half for visceral defects. At autopsy, no signs of embryotoxicity or teratogenicity were observed.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- clinical signs
- dead fetuses
- early or late resorptions
- mortality
- pre and post implantation loss
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 2 500 mg/kg bw/day (actual dose received)
Applicant's summary and conclusion
- Conclusions:
- The analogue substance was tested following a study desgin equivalent to OECD 414. Under the experimental conditions the NOALE is equal to 2500 mg/kg bw /day.
- Executive summary:
Pregnant SPF-derived Wistar rats distributed in groups of 30 animals were gavage-fed with analogue substance 4 at dose levels of 0, 250, 500 or 2500 mg/kg bw/day from day 0-19 of pregnancy (TNO, 1979). No abnormalities in condition or behaviour of the dams were observed. On day 21, the animals were killed and ovaries and uterus removed. The number of corpora lutea and the number and position of implantation sites were recorded. Live foetuses, embryonic and foetal resorptions, and dead foetuses were counted . Half the foetuses in the control and top dose groups were examined for skeletal malformations and the other half for visceral defects. At autopsy, no signs of embryotoxicity or teratogenicity were observed. In a preliminary study with 15 rats per group, similar results were obtained
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