Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 443-950-5 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 January 2001 to 18 July 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted in accordance with International Guidelines and in accordance with the principles of Good Laboratory Practise (GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): EH&S 01-114
- Lot/batch No.:XC1B1263A0
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gingrich Animal Supply, Inc, Fredericksburg, PA, USA
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: One per cage in suspeneded wire cages. Bedding was placed beneath the cages and changed at least 3 times a week.
- Diet (e.g. ad libitum): Fresh Purina rabbit chow (diet n.o 5321) was provided daily
- Water (e.g. ad libitum): Water was freely available at all times
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
The animal room was reserved exclusively for rabbits on acute tests, temperature was controlled, had a 12 hour light / dark cycle and was kept clean and vermin free.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipped free of hair
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: The prepared clipped area was 10 x 10 cm
- Type of wrap if used: The test article was placed under a 2.5 x 2.5 cm, 4 ply surgical gauze patch. The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period and prior to scoring the residual test material was removed from the test site by gentle washing with distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The test sites were scored for dermal irritation at 60 minutes following patch removel. Reactions were scored again at 24, 48 and 72 hours post dose. Erythema and edema were scored according to the Draize technique below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Dermal observations:
There was no erythema or edema noted at any time period. - Other effects:
- Systemic observations and bodyweight:
There were no abnormal physical signs noted.
All bodyweight changes were normal.
Any other information on results incl. tables
The test substance is not a dermal irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not a dermal irritant.
- Executive summary:
The study was performed to determine the irritant or corrosive effects of the test substance when applied dermally. The study was carried out based on the OECD Guideline no. 404 "Acute Dermal Irritation /Corrosion"
Method
Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (males) were dosed dermally with the test substance. The test substance (0.5 ml) was applied dermally to one intact site/rabbit. The test substance was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes following patch removal. Reactions were scored again at 24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest and at at termination.
Summary:
There was no erythema and edema noted at any observation time period.
There were no abnormal physical signs noted during the observation period.
All body weight changes were normal.
Conclusion:
The test substance is not a dermal irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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