Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- Skin irritation study was performed on New Zealand White rabbits to evaluate the irritation potential of 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Accilmation Period:Animals were held for 14 days after arrival in the facility but prior to use in tests to ensure that they are healthy.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and non abraded
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- Observations were made at 25, 48 and 72 hrs.
- Number of animals:
- 6
- Details on study design:
- Controls: Each animal served as its own control.As well as the test substance, a positive control substance (a known skin irritant, 1 % sodium lauryl sulfate in water) and a negative
control (plain gauze patch) are applied to the skin. Vehicle control was also used in case vehicle was used for the test substance.
TEST SITE
- Area of exposure: Rabbit’s back side was exposed with the test substance.
- % coverage: No data available
- Type of wrap if used: Saran Wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing of the test substance with an appropriate solvent or vehicle is done if the test substance applied is a colored test substance (such as dye).
- Time after start of exposure: No data available
SCORING SYSTEM: Dermal irritation scores for erythema and edema formation was evaluated by the scale proposed by Draize.
Persistent irritation score are also recorded, as well as the occurrence of eschar (+ E) and/or necrosis (+ N).
Results and discussion
In vitro
- Other effects / acceptance of results:
- No data available
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.3
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Moderate irritation effect was observed when the rabbits were exposed to the test substance potassium phthalimide for 24 hrs.
Any other information on results incl. tables
Table 2: Dermal Irritation Results and Classification
Chemical type |
Classification |
PDII |
FHSA |
Potassium phthalimide |
Moderate |
2.3 |
Irritant |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Moderate irritation effect was observed when the rabbits were exposed to the test substance potassium phthalimide for 24 hrs. The Primary Dermal Irritation Index (PDII) for Potassium Phthalimide after 24 hours was 2.3
Based on the scores, Potassium phthalimide can be considered to be moderate skin irritant. - Executive summary:
Skin irritation study was performed on New Zealand White rabbits to evaluate the irritation potential of potassium phthalimide. 6 New Zealand White rabbits were used for the study.Animals were held for 14 days after arrival in the facility but prior to use in tests to ensure that they are healthy. Each animal served as its own control. Along with the test substance, a positive control substance (a known skin irritant, 1% sodium lauryl sulfate in water) and a negative control (plain gauze patch) are applied to the skin. A vehicle control patch was also used in case the chemical was moistened with a vehicle or suspended in vehicle. Four test sites, two on each side of the rabbit's back, were utilized for administration of test chemical and controls.
A standard random pattern of administration ensured that the test substance and controls are applied to each position at least once in each test group. Each test or control substance is held in place with a 1x1 inch2 12-ply surgical gauze patch. The gauze patch is applied to the appropriate skin site and secured with 1-inch wide strips of Blenderm surgical tape, at the four edges, leaving the center of the gauze patch non-occluded. A 0.5-g portion of Potassium Phthalimide was weighed and placed on the gauze patch prior to application of the patch. The test substance and patch are then placed on the appropriate skin site and secured. The patch is subsequently moistened with 0.5 ml physiological saline.The study was on performed on both abraded and non-abraded animals.The negative control site is covered with an untreated 12-ply surgical gauze patch (1X1 inch2). The impervious material (Saran Wrap) aids in maintaining the position of the patches and retards evaporation of volatile test substances.
A Saf-T-Shield collar is fitted and fastened around the neck of each test animal. The collar remains in place for a 24 hr exposure period. The collar prevents the animal from removing the wrapping and patches.After the exposure period, the test substance skin site is wiped with dry gauze to remove any test substance still remaining.Dermal irritation scores for erythema and edema formation was evaluated by the scale proposed by Draize.The primary dermal irritation index (PDII) was calculated by dividing the sum of total irritation scores by the number of observations, and classifying the test substance:
0.00 = non-irritant ,>0.00 - 0.50 = negligible irritant, >0.50 -2.00 = mild irritant, >2.00-5.00 = moderate irritant, >5.00-8.00 = severe (primary) irritant.
Moderate irritation effect was observed when the rabbits were exposed to the test substance potassium phthalimide for 24 hrs. The Primary Dermal Irritation Index (PDII) for Potassium Phthalimide after 24 hours was 2.3
Based on the scores, Potassium phthalimide can be considered to be moderate skin irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.