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Diss Factsheets
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EC number: 227-999-8 | CAS number: 6065-82-3
- 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:
- supporting study
- Study period:
- From 12 March 1992 to 28 April 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non-GLP guideline study with deviations: only one animal tested (absence of skin irritation potential not confirmed with additional animals), and the same animal was used 7 days later for the ocular irritation test. The study report contains only limited descriptions on study design, housing conditions and results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- described in the directive 84/449/CEE
- Deviations:
- yes
- Remarks:
- only one animal tested, and the same animal was tested 7 days later for ocular irritation
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethyl diethoxyacetate
- EC Number:
- 227-999-8
- EC Name:
- Ethyl diethoxyacetate
- Cas Number:
- 6065-82-3
- Molecular formula:
- C8H16O4
- IUPAC Name:
- ethyl 2,2-diethoxy-acetate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole of Val de Selle
- Age at study initiation: no data
- Weight at study initiation: 3.2 kg
- Housing: no data
- Diet: no data
- Water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: nothing reported in the study report. Assumed to be an untreated area of the rabbit skin
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL unchanged - Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 1 hour, 24, 48 and 72 hours after the dressing removal
- Number of animals:
- 1 female
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
- Mode of administration: 0.5 mL of the test material was applied to the anterior flank of the female rabbit for 3 minutes. The posterior flank of the same animal received 0.5 mL of the test material for 4 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM: no data (assumed to be that described in directive 84/449/CEE)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- other: 1 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: 4-h application ; no other cutaneaous reaction after 24, 48 or 72h
- Irritation parameter:
- other: cutaneous reaction
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- other: 1 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cutaneaous reaction observed
- Irritation parameter:
- other: cutaneous reaction
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 24 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cutaneous reaction observed
- Irritation parameter:
- other: cutaneaous reaction
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cutaneous reaction observed
- Irritation parameter:
- other: cutaneous reaction
- Basis:
- animal #1
- Remarks:
- only one animal treated
- Time point:
- 72 h
- Remarks on result:
- no indication of irritation
- Remarks:
- no cutaneous reaction observed
- Irritant / corrosive response data:
- No skin reaction was observed following the 3 minutes application of the test material.
Only a slight erythema (score of 1) was observed at the 1 hour observation time point. No skin reactions were noted thereafter.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: based on the observed data
- Conclusions:
- Under the experimental conditions of this test, the test material was considered non irritant to the rabbit skin following 4 hours of exposure.
- Executive summary:
This non-GLP-compliant study was performed to assess the potential of the test material to induce skin irritation in vivo, according to the EU method B4 described in annex V of the 84/449/CEE directive.
Material and methods
0.5 mL of the test material were applied as supplied to the anterior flank of one female rabbit for 3 minutes. The posterior flank of the same animal received 0.5 mL of the test material for 4 hours.
The skin reactions were recorded 1 hour, 24, 48 and 72 hours after the dressing removal.
Results
No skin reaction was observed following the 3 minutes application of the test material.
Only a slight erythema (score of 1) was observed at the 1 hour observation time point. No skin reactions were noted thereafter.
Conclusion
Under the experimental conditions of this test, the test material was considered non-irritant to the rabbit skin following 4 hours of exposure.
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