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Registration Dossier
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Diss Factsheets
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EC number: 480-310-4 | CAS number: -
- 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 / corrosion, other
- Remarks:
- An adequate in vivo study was conducted on the test article prior to the requirement for in vitro data.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 February 2007 to 24 March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC, Council Directive 67/548/EEC, An. V, B.4 (2004), "Acute Toxicity: Dermal Irritation/Corrosion"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA, OPPTS 870.2500 (1998), Acute Dermal Irritation
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000) including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 6675
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Analytical purity: Formulation tested is 30% active ingredient in water.
- Purity test date: 12/20/2005
- Lot/batch no.: 140499-19/10
- Expiration date of the lot/batch: 01 December 2008
- Storage condition of test material: At room temperature in the dark
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Sex: male
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Fasting period before study: No data
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, Dimensions 56x44x37.5 cm)
- Diet (e.g. ad libitum): Pelleted diet for rabits (K-H from SSNIFF Spezialdiaten GmbH, Soest, Germany) approx 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1-22.5 degrees C
- Humidity (%): 40-58%
- Air changes (per hr): No Data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27 February 2007 To: 24 March 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the test substance (30% active ingredient in water)
- Concentration (if solution): 30% active ingredient in water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males were tested
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal (10x15 cm)
- % coverage: No data
- Type of wrap if used: Substance awas applied to the skin of one flank using a metalline patch of 2x3 cm. Patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin cleaned of residual test substance using tap water
- Time after start of exposure: 4 hours after application.
SCORING SYSTEM: Erythema and eschar formation (0-4)
Oedema formation (0-4)
Results and discussion
In vivo
Results
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- ca. 0 - ca. 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Overall PII score was 0.44
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The PII score for the test was 0.44. The test material does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and EC criteria for classification and labelling requirements for dangerous substances and preparations.
- Executive summary:
The purpose of this study was to assess the acute dermal irritancy of the test article in rabbits according to OECD Test Guideline 404. Three rabbits were exposed to 0.5 ml of the test article, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. Exposure to the test material resulted in well defined erythema in the treated skin-area of the rabbits which had resolved within 48 hours in two animals and within 72 hours in the other animal. No edema was noted. Under the conditions of the test, the test material caused slight to well-defined erythema when applied to the skin of rabbits. The test material does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and EC criteria for classification and labelling requirements for dangerous substances and preparations.
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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