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EC number: 214-046-6 | CAS number: 1074-82-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Correlation of Ocular and Dermal Irritancy of Industrial Chemicals
- Author:
- Shayne C. Gad, Robert D. Walsh & Brendan J. Dunn
- Year:
- 1 986
- Bibliographic source:
- Journal of Toxicology: Cutaneous and Ocular Toxicology; Vol 5(3); Pg. no. 195-214; 1986.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize method
- Principles of method if other than guideline:
- Eye irritation study was conducted on New Zealand White rabbits for determining the irritant potency of the test substance potassium phthalimide.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-potassium phthalimide
- EC Number:
- 214-046-6
- EC Name:
- N-potassium phthalimide
- Cas Number:
- 1074-82-4
- Molecular formula:
- C8H5NO2.K
- IUPAC Name:
- potassium 1,3-dioxo-1,3-dihydroisoindol-2-ide
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Phthalimide, potassium salt
- Molecular formula :C8H5NO2.K
- Molecular weight 185.223 g/mol
- Smiles notation : c12c(C(=O)[NH-]C1=O)cccc2.[K+]
- InChl: 1S/C8H5NO2.K/c10-7-5-3-1-2-4-6(5)8(11)9-7;/h1-4H,(H,9,10,11);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Phthalimide, potassium salt
- Molecular formula : C8H5NO2.K
- Molecular weight 185.223 g/mol
- Smiles notation : c12c(C(=O)[NH-]C1=O)cccc2.[K+]
- InChl: 1S/C8H5NO2.K/c10-7-5-3-1-2-4-6(5)8(11)9-7;/h1-4H,(H,9,10,11);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Details on test animals:
Acclimation Period:The quarantine period which was imposed during the study on the test animal is 14 days.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- no data available
- Duration of treatment / exposure:
- Exact duration of exposure to the test substance was not mentioned in the study paper but single exposure to the test substance was done at 0 day
- Observation period (in vivo):
- Observations were made at 1 hr, 1, 2, 3, 4, and 7 days after exposure.
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of the three rabbits are irrigated for 1 min with room temperature tap water using a polyethylene squeeze bottle, starting 20 sec after instillation.
- Time after start of exposure: No data available
SCORING SYSTEM: Grading and scoring of ocular irritation are performed in accordance with the standard Draize grades for ocular lesions.
Grades for Ocular Lesions:
Cornea Grade
No ulceration or opacity = 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible = (1)a
Easily discernible translucent area; details of iris slightly obscured = 2
Nacreous areas; no details of iris visible; size of pupil barely discernible = 3
Complete corneal opacity; iris not discernible = 4
Iris
Normal = 0
Markedly deepened folds, congestion, swelling, moderate circumcorneal injection; (any of these or combination of any thereof); iris reactive to light (a sluggish reaction is positive) = (1)a
Hemorrhage, gross destruction, or no reaction to light = 2
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Vessels Normal = 0
Some Vessels definitely injected = 1
Diffuse, crimson red; individual vessels not easily discernible = (2)a
Diffuse beefy red = 3
Chemosis
Normal = 0
Any swelling above normal (includes nictitating membrane) = 1
Obvious swelling, with partial eversion of lids = 2
Swelling, with lids about half closed = 3
Swelling, with lids more than half closed= 4
Where a= Lowest Grades considered positive under the Federal Hazardous Substances Regulation (FHSA) at 16 CFR1500.42
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 64
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- The mean Draize score was determined to be 64.0. Based on the mean Draize scores, Potassium phthalimide can be considered to be moderately irritating to eyes.
Any other information on results incl. tables
Table 2:
Ocular irritation results and Classification
Chemical Name |
Greens Scale |
Mean Draize Scores (24 hours) |
Potassium Phthalimide |
NA |
64.0 |
NA = Not Applicable, only the standard FHSA eye irritation study was performed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- When New Zealand White Rabbits were exposed to Potassium phthalimide, the mean Draize score was determined to be 64.0. Based on the mean Draize scores, Potassium phthalimide can be considered to be moderately irritating to New Zealand White rabbit eyes.
- Executive summary:
Eye irritation study was conducted on rabbits to check the eye irritation potential of the test compound potassium phthalimide.
9 New Zealand white rabbits used for the study. The contralateral eye of each test animal remains untreated and served as a control. 1 hr prior to instillation of the test substance, both eyes of each of at least 12 rabbits are examined for signs of irritation and corneal defects with a handheld slit lamp. Eyes are stained with a 2.0% sodium fluorescein and examined for confirming the absence of corneal lesions. At least 1 hr after fluorescein staining, the test substance is placed on one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup (conjunctival cul-de-sac) into which the test substance is dropped. The upper and lower lids are then held gently together for 1 sec to prevent immediate loss of material. All corneas are examined with the aid of sodium fluorescein. If fluorescein staining appears, diagrams of the staining patterns of the corneal area involved are recorded.If signs of irritation persist at 7 days, reading are continued on day 10. If irritation is still persistent on day 10, then readings are taken on day 14. Most lesions, if reversible, will heal or clear within 21 days. Therefore, if ocular irritation is present at the 14-day reading, a 21-day reading is required to determine whether the ocular damage is reversible or non-reversible.
The Federal Hazardous Substances Act (FHSA) Regulations was used to determine whether the test substance was an eye irritant or not. Interpretation of data was made using only the six test eyes not irrigated with water, and only data from days 1, 2, and 3.Grading and scoring of ocular irritation are performed in accordance with the standard Draize grades for ocular lesions.
When the test animals were exposed to the test substance potassium phthalimide,mean Draize score was determined to be 64.0.
Based on the mean Draize scores, Potassium phthalimide can be considered to be moderately irritating to New Zealand White rabbit eyes.
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