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Diss Factsheets
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EC number: 944-574-9 | 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:
- 02 March 1974 to 18 April 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US Federal Hazardous Substances Labelling Act
- Principles of method if other than guideline:
- The method employed in the testing was similar to that described in Section 1500.41 - Hazardous Substances and Articles. Administration and Enforcement Regulations, Federal Register, Vol 38 No 187 P.27019, 27 September 1973. Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used
- GLP compliance:
- no
- Remarks:
- Prior to GLP
Test material
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No details on test animals and environment provided
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Clipped with abraded and intact sites on each animal
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 24 hour occlusive exposure. The sites were not washed after the patches were removed.
- Observation period:
- 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24 & 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 & 72 houts
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24 & 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- Intact skin only
The test item elicited a well defined erythema response in all animals at the 24 and 72 hour observation. No other irritation response were noted.
Any other information on results incl. tables
Irritation effects on the intact skin only are considered for classification purposes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.
- Executive summary:
Introduction
The study was performed in accordance with the US Federal Hazardous Substances Labelling Act to assess the irritancy potential of the test item to the skin of rabbits.
Method and materials
The intact and abraded skin of 6 rabbits was used. The hair was clipped from the backs of the rabbits. One side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. GauzE patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used.
Results
A single 24-Hour, occluded application of the test item to the intact skin of six rabbits produced a well defined erythema response in all six animals at the 24 & 72 -hour observation No other irritation responses were noted.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.
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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