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EC number: 264-513-3 | CAS number: 63843-89-0
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Eighty subjects received occlusive plasters containing test preparations, on one arm, three times weekly for three weeks. After an interval of two weeks, single applications were made to both arms, followed by inspection at 48 and 96 hours.
- GLP compliance:
- no
Test material
- Reference substance name:
- Polypropylene containing 0.5 or 5% of CAS 63843-89-0
- IUPAC Name:
- Polypropylene containing 0.5 or 5% of CAS 63843-89-0
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: fine white powder
- Analytical purity: no data provided
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 80
- Sex: 4 males and 76 females
- Age: from 21 to 78 - Controls:
- only vehicle
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: patch strip consisting of four 22 mm diameter circular undressed lint (Webril, Curity) pads located along the centre of 50 mm wide adhesive tape (Blenderm, 3M Company)
- Vehicle / solvent: Carboxymethylcellulose in water
- Concentrations: 40% w/v or 50% w/v suspensions in 3% w/v carboxymethylcellulose in water
- Volume applied: 0.5 mL
- Testing/scoring schedule: Patches were applied on Monday, Wednesday and Friday of the three-week induction (insult) period. Patches were re-applied to the same site unless reaction to a test substance or to the plaster adhesive necessitated a move, in which case an adjacent location was chosen. Subjects who were absent once during the insult period received a make-up patch (MU) on the fourth Monday.
Fourteen days after the final induction patch (i.e. five weeks after the initial patch) applications were made to both arms of each subject. The sites were designated original (Or.) or alternate (Alt.) and the results were graded after 48 and 96 hours.
- Removal of test substance: after 24 hours
- Other: The patch strip was applied to the dorsal surface of the upper arm of each subject, the position being marked by three spots of methyl, violet stain.
EXAMINATIONS
- Grading/Scoring system: scoring after 24 hours after patch removal
Patch Scoring System:
0 - No visible reaction
1 - Mild reaction, erythema
1E - Mild erythematous reaction with papules and/or oedema
2 - Moderate reaction, erythema (a grade of 2 or higher during induction necessitates relocation of the patch)
2E - Moderate erythematous reaction with oedema and/or papules
3 - Strong reaction, erythema
3E - Strong eryrthematous reaction with marked oedema, papules and/or vesicles
4 - Severe reaction with erythema, oedema, papules and vesicles (may be evidence of weeping)
A - Marked reaction to adhesive (patch relocated)
L - Patch came off (lost) during first 12 hours
(-) - Subject absent
NP - In summary tables: total number not patched because of absence.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No evidence of sensitization was seen. The incidence of erythema, while low, appeared to be dose-related.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
Polymer without substance: numbers of reactions to 40% suspension in 3% carboxymethylcellulose
- Number of subjects with positive reactions: 2 after 48 hours; 1 after 96 hours (erythema score 1)
- Number of subjects with negative reactions: 78 after 48 hours; 79 after 96 hours
Polymer with 0.5% tet substance: numbers of reactions to 50% suspension in 3% carboxymethylcellulose
- Number of subjects with positive reactions: 10 after 48 hours; 3 after 96 hours (erythema score 1)
- Number of subjects with negative reactions: 70 after 48 hours; 77 after 96 hours
Polymer with 5% test substance: numbers of reactions to 50% suspension in 3% carboxymethylcellulose
- Number of subjects with positive reactions: 14 (13 x erythema score 1 and 1x erythema score 1E) after 48 hours; 4 after 96 hours (erythema score 1)
- Number of subjects with negative reactions: 66 after 48 hours; 76 after 96 hours
Applicant's summary and conclusion
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.
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