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EC number: 207-662-1 | CAS number: 487-68-3
- 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
Under the test conditions (OECD 404) the test substance is considered to be irritating to the skin.
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:
- other: Guideline study, available as unpublished report, minor restrictions, fully adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , occlusive conditions used
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Japanese White rabbits K bL:JW (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 2.2-2.4 kg
- Housing: individually housed in suspended metallic cages on a Z-type rabbit cage rack washable with water (ZR-18U, Natsume Seisakusho Co., Ltd.).
- Diet: Pellet food for rabbits RC-4 (Oriental Yeast Co., Ltd.), ad libitum.
- Water: Tap water, ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 6
- Photoperiod (hrs dark / hrs light):12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL on a circle of about 6 cm2 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6cm2
- Type of wrap if used: double-layer gauze and occlusively secured with Tegaderm (3M) and Tubicot No. 5 (Alcare Co., Ltd.)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Applied areas were wiped with gauze moistened with water.
- Time after start of exposure: 4 hours - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, and 72 hours
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- other: #2, #3
- Time point:
- other: mean 24, 48, and 72 hours
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24, 48, and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Two rabbits showed well-defined erythema (score 2) 30-60 min after 4-hr exposure. One rabbit showed very slight (barely perceptible) erythema (score 1), while another showed very slight (barely perceptible) edema (score 1). At 24 and 48 hrs after exposure, all three rabbits showed intensified dermal changes with well defined or moderate to severe erythema (score 3) and slight edema (score 2). A tendency toward recovery was noted thereafter, with all three rabbits showing a recovery with scale-like changes by 7 days after termination of exposure.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions (OECD 404) the test substance is considered to be irritating to the skin.
- Executive summary:
According to OECD guideline 404, a primary skin irritation study was conducted. The test substance was topically applied to the back skin (circular area of about 6 cm2) of 3 Japanese white rabbits for 4 hours under occlusive conditions. Two rabbits showed well-defined erythema (score 2) 30-60 min after exposure. One rabbit showed very slight (barely perceptible) erythema (score 1), while another showed very slight (barely perceptible) edema (score 1). At 24 and 48 hours after exposure, all three rabbits showed intensified dermal changes with well defined or moderate to severe erythema (score 3) and slight edema (score 2). A tendency toward recovery was noted thereafter, with all three rabbits showing a recovery with scale-like changes by 7 days after termination of exposure. Under the test conditions (OECD 404) the test substance is considered to be irritating to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
According to OECD guideline 404, a primary skin irritation study was conducted. The test substance was topically applied to the back skin (circular area of about 6 cm2) of 3 Japanese white rabbits for 4 hours under occlusive conditions. Two rabbits showed well-defined erythema (score 2) 30-60 min after exposure. One rabbit showed very slight (barely perceptible) erythema (score 1), while another showed very slight (barely perceptible) edema (score 1). At 24 and 48 hours after exposure, all three rabbits showed intensified dermal changes with well defined or moderate to severe erythema (score 3) and slight edema (score 2). A tendency toward recovery was noted thereafter, with all three rabbits showing a recovery with scale-like changes by 7 days after termination of exposure. Under the test conditions (OECD 404) the test substance is considered to be irritating to the skin.
Justification for selection of skin irritation / corrosion endpoint:
OECD guideline study, available as unpublished report, minor restrictions, fully adequate for assessment
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
Based on the skin irritation study, the substance has to be classified as Skin Irrit 2: H315: Causes skin irritation according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and as Xi:R38: Irritating to skin according to Directive 67/548/EEC.
In the absence of an eye irritation study, the justification for classification is based on the skin irritation study. Therefore, the substance is classified as Eye Irrit 2: H319: Causes serious eye irritation according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and as Xi:R36: Irritating to eyes 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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