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Diss Factsheets
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EC number: 459-290-6 | 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:
- from 2003, november 3rd to 2003, noivember 6th
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the OECD Guideline 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- SRID N°. : DEV5332
Physical State and Appearance : Solid, Tan powder
Source of Test Substance : Eastman Kodak Company
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test System
Three albino rabbits (Hra:(NZW)SPF) obtained from Covance Research Products, Inc.
(Denver, PA) were assigned to the study. The rabbits were young adults (at least three months
old) and weighed at least 2000 grams at the start of the study. Rabbits were chosen for this study
because they are a common representative species for dermal irritation studies. The rabbot is the
preferred species recommended for use in the OECD Guideline. The protocol was approved by
the Institutional Animal Care and Use Commitee.
Husbandry
Housing
Animals were housed in an Association for Assessment and Accreditation of Laboratory
Animal Care International-accredited vivarium in accordance with the Guide for the Care
and Use of Laboratory Animals (National Research Council, 1996). The rabbots were
singly housed in suspended, stainless-steel mesh cages. Cages and racks were washed
once a week. Absorbent paper, used to collect excreta, was changed every other day.
Environmental Conditions
The study room was maintained at 20.5 to 21.9°C and 46.3 to 56.2% relative humidity.
A photoperiod of 12 hours light was maintained.
Acclimation Period
The animals were isolated upon arrival and allowed to acclimate for a period of 5 days.
Animals were judged to be healthy prior to testing.
Feed
Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum. Feed containers
were cleaned and refilled at least once a week. No known contaminants which would
interfere with the outcome of this study were present in the feed. Analyses of feed are
maintained on file within the testing laboratory.
Water
Water was available ad libitum through an automatic watering system. The source of the
water was the local public water system. There have been no contaminants identified in
previuos water analyses that would be expected to interfere with the conduct of the study.
Semiannual analyses of water are maintained on file within the testing laboratory.
Identification
Upon arrival, all rabbits were identified by uniquely-numbered ear tags. Cage cards
contained the study-specific animal number and the ear tag number.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A single dose of 0.5 grams of test substance was applied topically to each animal using a fiber pad and an occlusive
wrap to hold the test substance in place. - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- The site of application was examined at 1, 24, 48 and 72 hours after removal of the
occlusive patch. Observations included estimation of erythema, edema, necrosis, eschar
formation, scarring, erosion, and staining caused by the test substance as well as general
systemic effects. - Number of animals:
- 3 animals numbered 751, 752 and 753.
- Details on study design:
- Grading the Irritant Response
The most severely affected area within the test substance application sites were scored for
dermal reactions. Corrsion was considered to have resulted if destruction or irreversible
alteration of the skin tissue (ulceration and/or necrosis) resulted after an exposure of
4 hours or less to the test substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- rabbit 751
- Time point:
- other: 1
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- rabbit 751
- Time point:
- other: 24
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- rabbit 751
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- rabbit 752
- Time point:
- other: 1
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- rabbit 752
- Time point:
- other: 24
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- rabbit 753
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- rabbit 753
- Time point:
- other: 1
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- rabbit 753
- Time point:
- other: 24
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- rabbit 753
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- rabbit 751
- Time point:
- other: 1
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- rabbit 751
- Time point:
- other: 24
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- rabbit 751
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- rabbit 752
- Time point:
- other: 1
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- rabbit 752
- Time point:
- other: 24
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- rabbit 752
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- rabbit 753
- Time point:
- other: 1
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- rabbit 753
- Time point:
- other: 24
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- rabbit 753
- Time point:
- other: 72
- Score:
- ca. 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No irritant response or serious lesion was noted during the 72-hour observation period.
- Other effects:
- No toxic effects were noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results, the test substance requires no skin irritation classification as defined in
the 18th Adaptation of the EC Classification, Packaging and Labelling of Dangerous Substances Directive. - Executive summary:
Prior to initiation of the dermal irritation study, a screening procedure was performed in an attempt to avoid testing a substance that might produce corrosion of the skin. First, the pH of the test substance was measured and the value obtained (5.622) demonstrated that the test substance was neither strongly acid (pH < or = 2.0) nor strongly alkaline (pH > or = 11.5). Subsequently, an in vitro test (Corrositex Assay) designed to identify substances that are corrosive to the skin was conducted, but the assay could not be performed due to a qualification issue using this test substance. Therefore, based on the pH value obtained and the lack of any further information on this test substance, an acute dermal irritation study was conducted.
Inthe in vivo rabbit study, no signs of irritation were evident at any time during the observation period. Therefore, the test substance was not considered a dermal irritant.
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