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EC number: 232-318-2 | CAS number: 8003-22-3 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 47000.
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from Study report
Data source
Reference
- Reference Type:
- other: study report
- Title:
- DERMAL, EYE, AND ORAL TOXICOLOGICAL EVALUATIONS Phase Report-II
- Author:
- Indu A. Muni, Elliot B. Gordon, Jane B. Goodband
- Year:
- 1 986
- Bibliographic source:
- Bioassay Systems Corporation 225 Wildwood Avenue Woburn, MA 01801
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Data from study report
- Principles of method if other than guideline:
- Skin irritation study was conducted for the test chemical CI Solvent yellow 33
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3-isobenzofurandione, reaction products with methylquinoline and quinoline
- EC Number:
- 232-318-2
- EC Name:
- 1,3-isobenzofurandione, reaction products with methylquinoline and quinoline
- Cas Number:
- 8003-22-3
- Molecular formula:
- C18H11NO2
- IUPAC Name:
- 2-(quinolin-2-yl)-2,3-dihydro-1H-indene-1,3-dione
- Details on test material:
- - Name of test material (as cited in study report): D&C Yellow No. 11
- Molecular formula (if other than submission substance): C18H11NO2
- Molecular weight (if other than submission substance): 273.29
- Substance type: Organic
- Physical state: Solid
- SMILES:O=C1C(c2ccc3ccccc3n2)C(=O)c2ccccc12
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Pine Acres Rabbi try, West Brattleboro, Vermont
- Age at study initiation: 8-15 weeks
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Individualy in stainless steel cages
- Diet (e.g. ad libitum): Fed Charles River Rabbit Formula (Agway) ad libitum
- Water (e.g. ad libitum): untreated municipal water via water bottle
- Acclimation period: 2 weeks
Or Test Tissue
- Source: No data available
- Type: No data available
- Acclimation : No data available
- Housing conditions: 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): Fluorescent lighting was controlled to provide a 12 hr light cycle (7AM to 7PM)
IN-LIFE DATES: From: To: No data available
Test system
- Type of coverage:
- other: Closed
- Preparation of test site:
- other: Abraded and unabraded skin
- Vehicle:
- physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 24 Hrs
- Observation period:
- 24, 48 and 72 hrs
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Trunk
- % coverage: No data available
- Type of wrap if used: Gauze pad moistened with saline was secured with surgical tape to the abraded and unabraded skin sites of animals. The trunk of the rabbit was wrapped in plastic wrap and then stockinette to prevent removal of the patches by the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed but excess test material was removed by wiping.
- Time after start of exposure:
SCORING SYSTEM: Draize
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- other: Erythema and eschar/edema
- Time point:
- other: 24hrs and 72 hrs
- Score:
- 0.02
- Max. score:
- 8
- Reversibility:
- no data
- Remarks on result:
- other: Irritation parameter: Negative
- Irritant / corrosive response data:
- Irritation parameter: Negative
- Other effects:
- Using the dual erythema and eschar/edema scales of Draize, add the average value of erythema and eschar responses at 24 and 72 hours for intact skin to the average values on abraded skin at 24 and 72 hours (total of 4 values before addition). Similarly, add the vaiues for edema formation at 24 and 72 hours for intact and abraded skin (4 values). The "value" recorded for each reading is the average value of the six or more animals subject to the test.
The sum of the eight values is divided by 4 to give the Primary Irritation Score. Compounds producing primary irritation scores of 0 are Non irritating. Irritation scores greater than 0 and less than or equal to 0.5 are practically non-irritating. Primary Irritation scores of 0.6 to 2 are only mildly irritating; whereas those with indexes from 2.1 to 5.4 are moderate irritants. and those with scores above 5.5 are considered severe irritants.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The primary irritation score for the test material CI Solvent Yellow 33 is found to be 0.02. Hence the compound is non –irritating to the skin of rabbits.
- Executive summary:
Primary dermal irritation study was conducted on 6 male/female rabbits to evaluate the irritation potency of the test chemical materialCI Solvent Yellow 33. 0.5g of solvent yellow 33 was applied to the abraded and unabraded sites of test rabbits.
The test sites were exposed for 24 hours at which time the rabbits were unwrapped and the test sites scored for irritancy using the method of Draize. The test sites were again scored at 72 hours. In studies where irritation persisted at 72 hours, additional scoring was made for all test sites at day 7. Similarly, irritation on day 7 would trigger further examination at day 14. The last day of scoring, if irritation was present on day 14, was day 21.
Application of 0.5 g of to 2 abraded and 2 unabraded test sites of 6 rabbits for 24 hours produced barely perceptible erythema to one abraded test site of one rabbit. This erythema resolved by 72 hours. There was no edema observed at any of the test sites at the 24 and 72 hour observation periods. The Primary Irritation Score for this test sample was 0.02 (practically non-irritating). Clinical signs indicative of systemic toxicity were not observed.
Hence the compound is non –irritating to the skin of rabbits.
In accordance with the CLP classification, the test material does not classify as a skin irritant.
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