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Diss Factsheets
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EC number: - | 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: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 22, 2010 - November 26, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): F10Fine
- Physical state: colourless solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 13 - 14 weeks
- Weight at study initiation: 3.4 - 3.5 kg
- Housing: individually in ABS - plastic rabbit cages
- Diet: ad libitum (autoclaved hay and Altromin 2123 maintenance diet)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: the substance was moistened with aqua ad injectionem
- Controls:
- other: the untreated right side of the dorsal area served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Vehicle: aqua ad injectionem (Delta Select, lot no. 05007A, expiry date: June 2013) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females (1 female subsequently followed by 2 females)
- Details on study design:
- TEST SITE
Approximately 25 hours before treatment, the dorsal fur was clipped with electric clippers.
The test item was applied to a gauze patch and was moistened with aqua ad injectionem.
The patch was then applied to the skin on a small area (approx. 6 cm^2) on the left side of the dorsal area.
The gauze was held in place with non-irritating tape. The patch was fixed with a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing: yes, using aqua ad injectionem
- Time after start of exposure: 4 hours
OBSERVATIONS
- Clinical signs: approximately 1, 24, 48 and 72 hours after patch removal
- Body Weight: at the start of the study and 72 hours after patch removal
- Irritation: the skin reactions were assessed at approximately 1, 24, 48 and 72 hours after patch removal. The irritation scores and a description of all other (local) effects were recorded.
SCORING SYSTEM
The irritation was assessed according to the numerical scoring system according to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: Mean value of score at 24, 48 and 72h after patch removal
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No irritant or corrosive effects were observed
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: Mean value of score at 24, 48 and 72h after patch removal
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No irritant or corrosive effects were observed
- Irritant / corrosive response data:
- No irritant or corrosive effects were observed
- Other effects:
- - No significant clinical signs of toxicity were observed
- No mortalities were observed
- No significant body weight changes were observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritation study with rabbits, performed in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles, no irritation was observed.
- Executive summary:
In an in vivo skin irritation study in rabbits, conducted in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles, 3 female rabbits were semi-occlusively exposed for 4 hours to 0.5 g of the (moistened) substance. No irritant or corrosive effects were observed. No significant clinical signs of toxicity nor mortalities were observed. Based on the result of this study, the substance does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.
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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