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Diss Factsheets
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EC number: 292-835-4 | CAS number: 91001-64-8
- 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:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a contract research organization. The study is scientifically valid and the report is fully adequate for assessment, despite some minor restrictions (e.g. due to limited reporting).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- of 1981
- Deviations:
- yes
- Remarks:
- Skin examination 0 h, 48 h and 6 days after patch removal
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Division of Pharmacology, FDA
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Number: 5 animals,
- Average bodyweight: 3 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded versus only shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of neat test substance was administered to the skin by means of a "2.5 cm2" cellulose patch.*
* Comment by the data submitter:
There is no indication in the report, whether the size of treated skin patches was inadvertently stated as only "2.5 cm2" in reality having been sized 2.5 cm x 2.5 cm (i.e. ca. 6 cm2) or whether, contrarily to the cited OECD 404 test guideline, the size of the treated skin patches was really confined to only 2.5 cm2. Regardless whether the treated skin patch was ca. 6 cm2 or only 2.5 cm2, the study results are considered to be valid for assessment. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days (i.e. the final observation time point was 6 days post patch removal)
- Number of animals:
- 5
- Details on study design:
- TEST SITE PREPARATION
Samples of 0.5 mL of the neat test substance were applied to the shaved intact and to shaved and then abraded skin of albino rabbits by means of cellulose patches. Patches were fixed with leucoplast and the whole trunk of each animal was enwrapped by a rubber cloth during the 24 hour treatment period, in order to delay evaporation of substances. From the coverage of the whole animal trunk (patches inclusive) with rubber cloth occlusive treatment was concluded by the data submitter, although the report did not specify whether this coverage was considered to be occlusive or semi-occlusive.
Two untreated skin sites (one of shaved intact skin and one of shaved and then abraded skin) served as controls. Only skin reactions different to controls were graded as positive skin reactions.
TREATMENT PERIOD AND REMOVAL OF TEST SUBSTANCE
Occlusive treatment lasted 24 hours. Then the dressings were removed. There was no mentioning in the report that exposed skin patches were cleaned from residual test substance after treatment.
TIME POINTS OF SKIN EVALUATION:
The treated skin patches were evaluated 24 and 72 hours and 7 days post application (i.e. immediately and 48 hours and 6 days post patch removal). The scoring system for the grading of skin reactions is listed in Table 1 (next field below).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema formation was not evident
- Remarks on result:
- other: Neat test substance administered to intact skin for 24 hours
- Irritation parameter:
- edema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: edema formation was not evident
- Remarks on result:
- other: Neat test substance administered to intact skin for 24 hours
- Irritation parameter:
- erythema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema formation was not evident
- Remarks on result:
- other: Neat test substance administered to abraded skin for 24 hours
- Irritation parameter:
- edema score
- Remarks:
- as defined in Table 1
- Basis:
- mean
- Remarks:
- over 5 animals and 2 time points
- Time point:
- other: 24 and 72 h post treatment start
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: edema formation was not evident
- Remarks on result:
- other: Neat test substance administered to abraded skin for 24 hours
- Irritant / corrosive response data:
- In each animal, shaved intact skin patches treated with neat test substance and shaved abraded skin patches treated with neat test substance were free from erythema, scab or edema formation at any observation time point of the study.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
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