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EC number: 208-584-0 | CAS number: 534-03-2
- 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
Endpoint summary
Administrative data
Description of key information
Skin: not irritating
Eye: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: 40 CFR, Part 798, Subpart E Section 798.4470, Toxic Substances Control Act, 1994
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: test substance was slightly moistened with USP 0.9% sodium chloride for injection
- Controls:
- other: Adjacent areas of untreated skin served as control sites
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, slightly moistened with USP 0.9% sodium chloride for injection - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sited were wiped clean.
- Time after start of exposure: 4 hours.
SCORING SYSTEM:
Performed according to the Draize method - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- None of the test animals exhibited signs of erythema or edema during the 72 hour observation period. All the scores were 0 at all reading time points.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: 40 CFR, Part 798, Subpart E Section 798.4500, Toxic Substances Control Act, 1985
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right, untreated eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Test substance was not washed from the eye after administration
- Observation period (in vivo):
- 96 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM:
The eyes were examined at 1, 24, 48, 72 and 96 hours after administration and scored according to the Draize method for scoring ocular lesions
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The substance was considered to be corrosive.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The substance was considered to be corrosive.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The substance was considered to be corrosive.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The substance was considered to be corrosive.
- Irritation parameter:
- other: pannus (corneal vascularisation)
- Basis:
- other: 4/6 animals
- Time point:
- other: 96 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: The study was terminated when pannus was observed. The substance was considered to be corrosive.
- Irritant / corrosive response data:
- All six test animals exhibited positive scores for irritation. Fluorescein staining was observed in 5/6 animals. In addition 4/6 animals developed pannus (corneal vascularization) by the 96-hour observation point. The study was terminated when pannus was observed. The control eye of all animals was normal (grade 0) throughout the observation period.
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Cat. 1, H318
DSD: Xi, R41
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A skin irritation study (Lister, 1995c) was performed according to 40 CFR, Part 798, Subpart E Section 798.4470, Toxic Substances Control Act, 1994). The test substance was applied to the shaved skin of 6 rabbits and covered with a semi-occlusive dressing for 4 hours. None of the 6 test animals exhibited any signs of erythema or edema during the 72-hour observation period.
These findings were confirmed in the acute dermal toxicity study performed by Lister (1995). In this study APD was administered to rats as a single dose of 2000 mg/kg bw under occlusive conditions for 24 hours.
Therefore, APD is considered not to cause skin irritation under the conditions of these studies.
An eye irritation study was performed using the test substance on rabbits, according to 40 CFR, Part 798, Subpart E Section 798.4500, Toxic Substances Control Act, 1985 (Lister, 1995d). APD was instilled into the eye of the animals and left without washing the eye at any time point. All 6 animals exhibited irritation of the exposed eye and 4/6 developed pannus (corneal vascularisation) within 96 hours. As this is an irreversible effect, the study was terminated after 96 hours. In conclusion, the substance was corrosive to the eye under the conditions of this study.
Effects on eye irritation: corrosive
Justification for classification or non-classification
The available data on skin irritation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification. The available data on eye irritation of the test substance meet the criteria for classification as Category 1 (H318) according to Regulation (EC) 1272/2008 and as Xi R41 according to Directive 67/548/EEC.
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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