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EC number: 401-300-8 | CAS number: 86168-95-8
- 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
- Study period:
- 1985-02-05 to 1985-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404) according to GLP Deficiencies by guideline updates: simultaneous administration of test item to three animals - no sequential approach of dosing. However, this did not compromise the quality of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12 , 1981
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Physical state: solid, insoluble in water
- Analytical purity: commercial grade
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- The test was performed on 3 male New Zealand white rabbits (KFM-NZW), checked for normal skin conditions.
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: Individually in metal cages, identified with individually numbered ear tags
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Fresh water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: Constant room temperature of 20±3 °C
- Humidity: Relative humidity of 30-70 %
- Photoperiod: 12 hours light cycle day
All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results are available at the animal supply office. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). Results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to Ciba-Geigy Ltd., as well as the results of in house chemical analysis by the analytical laboratories of the Pharmaceuticals Division, Ciba-Geigy Ltd.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: A control gauze patch was applied to the contralateral flank
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
An area of about 6 sq.cm was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water. The patches were covered with an occlusive membrane and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: about 6 sq cm on the flank
- Type of wrap if used: gauze patch covered with an occlusive membrane
SCORING SYSTEM: according to OECD
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs (mean)
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs (mean)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs (mean)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hrs (mean)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs (mean)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs (mean)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- At the 1 hour timepoint, one animal showed mild edema and erythema reactions, reversible within 48 and 72 hours, respectively. The remaining two animals showed only minimal erythema reactions at the 1 hour time point. This effect was reversed to normal within 1 day.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test article caused only minimal skin reactions and is therefore considered to be not irritating to the rabbit skin.
- Executive summary:
In a GLP-compliant skin irritation study performed according to OECD guideline 404, three New Zealand White rabbits were treated occlusively with 0.5 g of the test article. The test article was applied with a moistened gauze patch to the clipped flank of the animals and held in place for 4 hours by an adhesive tape. Control patches were applied to the contralateral flank. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches and animals were checked daily for signs of systemic toxicity. Under the experimental conditions employed the test article induced minimal to mild erythema and edema reactions well below the threshold of significance. All signs of irritations disappeared within 72 days the latest. The test article is therefore classified as non irritating.
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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