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Diss Factsheets
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EC number: 243-421-7 | CAS number: 19900-69-7
- 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
- Study period:
- October 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- internal substance code
- IUPAC Name:
- internal substance code
- Test material form:
- liquid: viscous
- Details on test material:
- The test article was a brown viscous liquid supplied in a glass screw-capped bottle labelled P5240. The test article was stored at room temperature in the dark. Information supplied by the study sponsor indicated the test article was stable under normal conditions.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species, strain and supplier:
Three young adult female New Zealand White rabbits obtained from Morton Commerical Rabbits, Parsonage Road, Stansted, Essex, were used for the study.
Specification:
At the start of the study the rabbits weighed between 2.55 and 2.83 kg and were at least 11 weeks old. They were acclimatised to the laboratory environment for at least 3 days and were examined for signs of ill health or injury shortly before the study commenced. All animals appeared healthy and no animals were rejected.
Husbandry:
The animals were individually housed in grid floor cages in a single air conditioned room at a temperature between 18 and 20°C and a relative humidity between 51 and 62%. The animals were exposed to a constant daily photoperiod of 14 hours artificial light (06.00 - 20.00) and 10 hours darkness. Temperature and humidity were recorded twice daily on weekdays and once daily at week-ends.
Diet and drinking water:
The animals were allowed free access to mains water and food (Standard Rabbit Diet, Special Diets Services Ltd., Stepfield, Witham, Essex) throughout the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped the day prior to treatment
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The test article was melted by warming to approximately 70°C. The test article was allowed to cool to approximately 37°C at
which temperature it was sufficiently liquid to be administered by a 1 ml syringe. The test article concentration applied was 0.5 ml undiluted. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 female rabbits
- Details on study design:
- Treatment procedure:
The back of each animal was clipped free of hair the day prior to treatment using electric veterinary clippers. A portion of test article (0.5 ml) was applied to an area of skin approximately 6 cm2 on each animal and covered with a gauze patch. The patch was occluded and secured using a strip of impermeable adhesive tape. A plastic collar was placed around the neck of each animal to
prevent premature removal of the wrappings and ingestion of the test article. Four hours after application the patches were
removed and the skin wiped with a disposable paper towel moistened with water to remove any test article still remaining.
Evaluation of effects:
One hour after removal of the wrappings the skin reactions were scored using the Draize scale. The evaluation was repeated 24,48 and 72 hours after removal of the patches. No irritation was noted at the 72 hour observation and the study was terminated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All treated skin sites appeared normal throughout the study period. A primary irritation index of 0 was obtained. The test item was regarded as non-irritant to rabbit skin. No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was classified as a non-irritant to rabbit skin.
- Executive summary:
A study was performed to determine the primary skin irritation index and corrosive effects of the test item in the New Zealand White rabbit. The study design was based on OECD Guidelines No. 404. Three female rabbits were tested and 0.5 ml test substance applied undiluted onto the clipped skin area of the animals. A single 4 -hour application produced a primary irritation index of 0. The test item was classified as a non-irritant to rabbit skin. No corrosive effects were noted.
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