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EC number: 219-868-9 | CAS number: 2556-10-7
- 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
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:
- with 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:
- 72 hours
- Number of animals:
- 12 animals - 6 with intact skin and 6 with abraded skin (results for abraded skin are disregarded).
- 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 from the start of exposure (so directly after exposure, at time point 0 h after patch removal) and after 72 hours (so at time point 48 h 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:
- animal #1
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 0 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 0 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 0 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 24 hours and 72 hours timepoints were not scored
- Irritant / corrosive response data:
- The test substance caused moderate skin irritation. Its dermal effects observed after 24 hours of exposure (so at time point 0 h after patch removal) generally consisted of very slight to moderate erythema and very slight edema. Dermal effects observed after 72 hours after exposure (so at time point 48 h after patch removal) consisted of 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), which can be considered the worst-case effect. Based on the available eythema and edema scores and given the longer exposure period (24 instead of 4 hours), it is concluded that classification for CLP purposes can be assessed with the current test as it can be seen as a worst-case.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a skin irritant
- Remarks:
- Based on EU CLP criteria (EC 1272/2008 and its updates)
- Conclusions:
- Hyacinth body was tested in a study similar to OECD TG 404 and based on the results it was concluded not to be a skin irritant.
- Executive summary:
The skin irritation potential of Hyacinth body was tested in an in vivo study performed similar to OECD TG 404 with some deviations on exposure time and observation period and therefore a Klimisch 2 rating was assigned. In this study, 12 New Zealand white rabbits were used, 6 with intact skin and 6 with abraded skin. 24 hours prior to dosing the hair was removed from the back with a clipper. 0.5 mL testing material was applied on the skin under a surgical patch 1x1 inch. After the exposure period of 24 hours patches were removed. Only testing results of animals with intact skin were considered for evaluation of skin irritation. Observations made directly upon patch removal are treated as time point 0 h and the observations made at 48 hours after patch removal are treated as time point 48 h. The 24 h and 72 h time points were not scored, therefore the only 48 h results could be taken into consideration. Effects observed upon patch removal (so at time point 0 h) were limited. Slight to moderate erythema was observed (1 animal with score 3, 2 animals with score 2, 2 animals with score 1 and 1 animal with score 0) and none to slight edema (3 animals with score 1 and 3 animals with score 0). This was not sufficient to consider the substance a skin irritant. The decreased presence of dermal effects observed 48 hours after patch removal supports this finding. A slight to moderate erythema was then observed (1 animal scored 2 and 2 animals scored 1), none to slight edema (1 animal scored 1 and 5 animals scored 0) and a slight scaliness. Under the conditions of this test, some erythema and edema effects were observed directly after patch removal but only an erythema score for one animal was above the classification threshold. When taking the results from 48 h, though, none of the animals exceeded the score 2.3 for erythema or oedema (which is a criterion for EU CLP classification). 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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