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EC number: 270-648-9 | CAS number: 68475-50-3
- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Datais from National Toxicology Program
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Acute oral toxicity study of C.I. Acid Orange 10 in rats
- GLP compliance:
- not specified
- Test type:
- other: No data
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 7-hydroxy-8-phenylazonaphthalene-1,3-disulphonate
- EC Number:
- 217-705-6
- EC Name:
- Disodium 7-hydroxy-8-phenylazonaphthalene-1,3-disulphonate
- Cas Number:
- 1936-15-8
- Molecular formula:
- C16H10N2Na2O7S2
- IUPAC Name:
- disodium 7-hydroxy-8-(phenyldiazenyl)naphthalene-1,3-disulfonate
- Reference substance name:
- C.I. ACID ORANGE 10
- IUPAC Name:
- C.I. ACID ORANGE 10
- Details on test material:
- - Name of test material (as cited in study report):C.I. Acid Orange 10 - Molecular formula (if other than submission substance):C16H10N207S2.2Na - Molecular weight (if other than submission substance):452.37 g/mole - Substance type:Organic - Physical state:No data available Purity80% pure - Impurities (identity and concentrations):20 %
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: NCI Frederick Cancer Research Center, Frederick, Maryland- Age at study initiation: Male: 6 weeks old, Female: 5 weeks old - Weight at study initiation: No data available - Fasting period before study: No data available - Housing: Animals were housed five per cage in solid-bottom polycarbonate cages (LabProducts, Inc., Garfield, NJ) equipped withDuPont 2024 spun-bonded polyester filters and supplied with Absorb-Dri hardware chips (Lab Products, Inc.). Cages and bedding were changed twice weekly. - Diet (e.g. ad libitum): Ralston Purina Laboratory Chow Meal, ad libitum, Feed hoppers were changed once per week.- Water (e.g. ad libitum): Tap water, supplied by an automatic watering system (Edstrom Industries, Waterford, WI), ad libitum- Acclimation period: 2 weeks ENVIRONMENTAL CONDITIONS- Temperature (°C): 21° and 23° C- Humidity (%): 40%-60% - Air changes (per hr): Incoming air was passed through a filter equipped with an electrostatic precipitator at a volume equivalent to 15 changes per hour.- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided 12 hours per day.IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Ralston Purina Laboratory Chow Meal
- Details on oral exposure:
- VEHICLE- Concentration in vehicle: 600, 1250, 2500, 5000, 10000 and 20000 mg/kg bw- Amount of vehicle (if gavage): No data available - Justification for choice of vehicle: No data available - Lot/batch no. (if required): No data available - Purity: No data available MAXIMUM DOSE VOLUME APPLIED: No data available DOSAGE PREPARATION (if unusual): C.1. Acid Orange 10 was mix with weighed amounts of Purina Laboratory Chow animal meal in a Patterson Kelly twin shell blender for 15 minutes. Formulated diets were stored at 23° C for no longer than 10 days.CLASS METHOD (if applicable)- Rationale for the selection of the starting dose: No data available
- Doses:
- 600, 1250, 2500, 5000, 10000 and 20000 mg/kg bw
- No. of animals per sex per dose:
- Total: 60600 mg/kg bw: 5 male , 5 female 1250 mg/kg bw: 5 male , 5 female2500 mg/kg bw: 5 male , 5 female5000 mg/kg bw: 5 male , 5 female10000 mg/kg bw: 5 male , 5 female20000 mg/kg bw: 5 male , 5 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: No data available - Necropsy of survivors performed: yes- Other examinations performed: survival and clinical sign were observed.
- Statistics:
- No data available
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No effect on survival, clinical sign and gross pathology
- Mortality:
- No effect on survival of treated male and female rats was observed.
- Clinical signs:
- other: No clinical sign were observed in treated male and female rats.
- Gross pathology:
- No gross pathological changes were observed in treated male and female rats.
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- LD50 was considered to be >20000 mg/kg bw when F344/N male and female rats were treated with C.I. ACID ORANGE 10 orally in feed for 24 hours.
- Executive summary:
In a acute oral toxicity study,F344/N male and female rats were treated with C.I. ACID ORANGE 10 in the concentration of600, 1250, 2500, 5000, 10000 and 20000 mg/kg bw orally in feed and observed for 14 days. No effect on survival and clinical sign were observed in treated male and female rats. In addition, No gross pathological changes were observed in 20000 mg/kg bw treated male and female rats. Therefore, LD50 was considered to be>20000 mg/kg bw when F344/N male and female rats were treated with C.I. ACID ORANGE 10 orally in feed for 24 hours.
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