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EC number: 220-491-7 | CAS number: 2783-94-0
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- 90–day dermal toxicity data for Acid Orange 7
- Author:
- Toilet Goods Association
- Year:
- 1 962
- Bibliographic source:
- Color Additive Master File No. 9; Entry 54; Submitted to the Toilet Goods Association; 1962 (sample 82574)
- Reference Type:
- publication
- Title:
- OPINION ON Acid Orange 7
- Author:
- European Commission
- Year:
- 2 011
- Bibliographic source:
- Scientific Committee on Consumer Safety SCCS OPINION ON Acid Orange 7 COLIPA n° C15;22 March 2011
Materials and methods
- Principles of method if other than guideline:
- The repeated dose toxicity study was conducted to evaluate the toxic effects of administration of Acid Orange 7 to rabbits by the dermal route for 90 days.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
- EC Number:
- 211-199-0
- EC Name:
- Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
- Cas Number:
- 633-96-5
- Molecular formula:
- C16H12N2O4S.Na
- IUPAC Name:
- sodium 4-[(2-hydroxy-1-naphthyl)diazenyl]benzenesulfonate
- Reference substance name:
- 633-69-5
- IUPAC Name:
- 633-69-5
- Details on test material:
- - Name of test material (as cited in study report):Acid Orange 7
- Substance type:organic
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: water as well as USP White Ointment
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- For abraded skin for 21 days
For intact skin for 90 days. - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,0.1 and 1.0% (Equivalent to 1000 and 10000 mg/kg)
Basis:
- No. of animals per sex per dose:
- 0 mg/l = 3 animals
1000 mg/l =3 animals
10000 mg/l =3 animals - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
HAEMATOLOGY: Yes
URINALYSIS: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- no mortality was observed.
- Dermal irritation:
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- no mortality was observed.
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematological values was normal
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- urinary components were normal
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Gross autopsies disclosed no dose-related findings.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- no effects observed
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 other: mg/kg
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Effects: There was no mortality or any evidence of systemic toxicity. Haematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The 90 days subchronic repeated dose dermal study on rabbit indicated that no effects observed on mortality, urinalysis, haematology and histopathology.
Thus, on the basis of study results the NOAEL (no observed adverse effect level) was observed to be 10000 mg/kg. - Executive summary:
In order to determined the repeated dermal toxicity of Acid Orange 7, a 90 days repeated dose toxicity study in rabbits was conducted at dose levels of 0(control),0.1 and 1.0% (Equivalent to 1000 and 10000 mg/kg) by dermal route .
From experimental study there was no mortality or any evidence of systemic toxicity. Hematological values, growth responses and urinary components were normal. Gross autopsies disclosed no dose-related findings.
Thus, on the basis of above results the NOAEL (no observed adverse effect level) for Acid Orange 7 considered to be 10000 mg/kg.
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