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EC number: 231-327-9 | CAS number: 7493-57-4
- 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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- The skin irritation information of this source substance is used for read across to Hyacinth body #3.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Information derived from analogue
- Justification for type of information:
- The read across justification is presented in the Irritation / corrosion Endpoint summary. The accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 4 and 6
- Time point:
- 24/48/72 h
- Score:
- 1
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- score of animal number 5
- Time point:
- 24/48/72 h
- Score:
- 2
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- scores of animal number 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- score of animal number 5
- Time point:
- 24/48/72 h
- Score:
- 1
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- score of animal number 3
- Time point:
- other: 0 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 1 and 2
- Time point:
- other: 0 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 4 and 6
- Time point:
- other: 0 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- score of animal number 5
- Time point:
- other: 0 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- scores of animal number 1, 2 and 3
- Time point:
- other: 0 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- scores of animal number 4, 5 and 6
- Time point:
- other: 0 h
- Score:
- 1
- Irritant / corrosive response data:
- The test substance was found to induce some skin irritation effects. After 24 hours exposure very slight to moderate erythema and very slight edema was observed. Dermal effects observed 48 hours after patch removal were very slight or well-defined erythema, slight scaliness and very slight edema.
- Interpretation of results:
- other: not skin irritating
- Remarks:
- Based on CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Skin irritation: not irritating (read-across from Hyacinth body tested in OECD TG 404).
To be able to derive a CLP classification from skin irritation test results, normally the 24, 48 and 72 hours timepoints (after patch removal) for erythema and edema are used. In this study only the 48 hours timepoint is available for evaluation. As supporting evidence the reading directly after removal of the patch is available (0 hours timepoint) and can be considered the worst-case effect. Based on the available eythema and edema scores and the longer exposure period (24 instead of 4 hours), it is concluded that interpretation of the study for CLP purposes is possible with the current test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure period was 24 h instead of 4 h, observation time points were 0 and 48 h after patch removal instead of 24, 48 and 72 h.
- GLP compliance:
- no
- Remarks:
- pre-GLP
Test material
- Reference substance name:
- [2-(1-ethoxyethoxy)ethyl]benzene
- EC Number:
- 219-868-9
- EC Name:
- [2-(1-ethoxyethoxy)ethyl]benzene
- Cas Number:
- 2556-10-7
- Molecular formula:
- C12H18O2
- IUPAC Name:
- [2-(1-ethoxyethoxy)ethyl]benzene
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Details on test animals or test system and environmental conditions:
- No details provided.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- electric clipper, avoiding abrasions
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml testing material
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48 hours after patch removal
- Number of animals:
- 12 animals - 6 with intact skin and 6 with abraded skin (results for abraded skin are disregarded in this study record).
- Details on study design:
- TEST SITE:
- Area of exposure: 1x1 inch
- Type of wrap if used: surgical patch, fixed to application site with adhesive tape and entire trunk of rabbits is wrapped with impervious material.
OBSERVATION TIME POINTS:
After 24 hours (directly after exposure) and after 72 hours (48 hours after patch removal).
SCORING SYSTEM:
Method of calculation: Draize (J. Pharmacol. 82 (1944) 377-390).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 1, 2 and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 4 and 6
- Time point:
- 24/48/72 h
- Score:
- 1
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- score of animal number 5
- Time point:
- 24/48/72 h
- Score:
- 2
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- scores of animal number 1, 2, 3, 4 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- score of animal number 5
- Time point:
- 24/48/72 h
- Score:
- 1
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- score of animal number 3
- Time point:
- other: 0 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 1 and 2
- Time point:
- other: 0 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- scores of animal number 4 and 6
- Time point:
- other: 0 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- other:
- Remarks:
- score of animal number 5
- Time point:
- other: 0 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- scores of animal number 1, 2 and 3
- Time point:
- other: 0 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other:
- Remarks:
- scores of animal number 4, 5 and 6
- Time point:
- other: 0 h
- Score:
- 1
- Irritant / corrosive response data:
- The test substance was found to induce some skin irritation effects. After 24 hours exposure very slight to moderate erythema and very slight edema was observed. Dermal effects observed 48 hours after patch removal were very slight or well-defined erythema, slight scaliness and very slight edema.
Any other information on results incl. tables
To be able to derive a CLP classification from skin irritation test results, normally the 24, 48 and 72 hours timepoints (after patch removal) for erythema and edema are used. In this study only the 48 hours timepoint is available for evaluation. As supporting evidence the reading directly after removal of the patch is available (0 hours timepoint) and can be considered the worst-case effect. Based on the available eythema and edema scores and the longer exposure period (24 instead of 4 hours), it is concluded that interpretation for CLP purposes is possible with the current test.
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin irritating
- Remarks:
- Based on CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Hyacinth body is not an irritant to skin, according to OECD 404.
- Executive summary:
The skin irritation potential of Hyacinth body was tested in vivo using 12 New Zealand white rabbits (6 with intact skin and 6 with abraded skin). Study was performed similar to OECD 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. The test material was applied on the skin under a surgical patch. After an exposure period of 24 hours the patches were removed. Only testing results of 6 animals with intact skin are considered useful for evaluation of skin irritation. The animals were observed only at 48 hours after patch removal and no observations were done at time points of 24 and 72 hours. Effects observed directly upon patch removal were limited. Regarding erythema, 1 animal scored 3, 2 animals scored 2, 2 animals scored 1 and 1 animal scored 0, and regarding edema, 3 animals scored 1 and 3 animals scored 0. The dermal effects observed at 48 hours after patch removal were decreased to none to moderate erythema (1 animal scored 2, 2 animals scored 1 and 3 animals scored 0) and none to slight edema (1 animal scored 1 and 5 animals scored 0). Directly after patch removal only the erythema score for one animal was above the classification threshold (score 3). Although the study was not continued until the complete disappearance of the effects, the effects decreased largely within the 48 hours after patch removal. Given the longer exposure period of 24 instead of 4 hours and the test results obtained, it can be concluded that Hyacinth body is not an irritant to skin.
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