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EC number: 685-616-3 | CAS number: 66094-79-9
- 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:
- Between 24 June and 15 July 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted in compliance with OECD Guideline No. 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Directive n° 2004/73/EC.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2008-04-14&15 / Signed on 2008-07-16.
Test material
- Reference substance name:
- (3S)-3-ethyl-5,5-dimethyloxolan-2-one
- Molecular formula:
- C8 H14 O2
- IUPAC Name:
- (3S)-3-ethyl-5,5-dimethyloxolan-2-one
- Reference substance name:
- (3R)-3-ethyl-5,5-dimethyloxolan-2-one
- Molecular formula:
- C8 H14 O2
- IUPAC Name:
- (3R)-3-ethyl-5,5-dimethyloxolan-2-one
- Test material form:
- liquid
- Details on test material:
- - Physical state: colourless translucent liquid
- Storage condition of test material: Room temperature
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - The test item was considered at 100% for the study
- Date received: 02 June 2008
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe).
- Weight at study initiation: 2.17 - 3.07 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SDS –C15), ad libitum
- Water: tap-water from public distribution, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19-24°C
- Humidity: 40-66%
- Air changes: at least ten changes per hour.
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From 24 June To 15 July 2008.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test item was applied as supplied. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the patch.
- Number of animals:
- 3 females
- Details on study design:
- PRETEST
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.
TEST SITE
- Area of exposure: Undamaged skin area of one flank of each animal
- Type of wrap if used: Patch was secured in position with a strip of surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).
SCORING SYSTEM:
- Method of calculation: Skin irritant reaction was scored as per Draize scale according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- - It was noted, 24 hours after the test item application, on the treated area, a slight to well defined erythema associated with a slight oedema in two animals. The oedematous reactions were totally reversible at D2 and the erythematous reactions were totally reversible between D2 and D3.
- On the cutaneous structure, slight dryness was noted on the treated area, from D2 in two animals and from D3 in the last one. Slight dryness was still noted at the end of the observation time (D14) in two animals. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Individual and mean skin reactions/Erythema - Eschar formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A9134/Female |
A9149/Female |
A9150/Female |
||
Erythema/Eschar formation |
24 h |
1 |
1 |
2 |
48 h |
0 |
0 |
1 |
|
72 h |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
1 |
1 |
3 |
|
Mean (24, 48 and 72 hours) |
0.3 |
0.3 |
1 |
Table 7.3.1/2: Individual and mean skin reactions/Oedema formation following 4 hour exposure
Skin reaction |
Observation time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
A9134/Female |
A9149/Female |
A9150/Female |
||
Oedema formation |
24 h |
0 |
2 |
2 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Total (24, 48 and 72 hours) |
0 |
2 |
2 |
|
Mean (24, 48 and 72 hours) |
0 |
0.7 |
0.7 |
Note
A9134: slight dryness between D2 and D5
A9149: slight dryness between D2 and D3, D6 and D10; D13 and D14
A9150: slight dryness at D3 between D6 and D10; D13 and D14
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritant to the skin according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test item was applied on an undamaged skin area of the flank of 3 female New Zealand White rabbits. On the other flank an untreated area was served as the control. Test sites were covered with a semi-occlusive dressing for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hours after removal of the patch. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated during 4 hours.
It was noted, 24 hours after the test item application, on the treated area, a slight to well defined erythema associated with a slight oedema in two animals. The oedematous reactions were totally reversible at D2 and the erythematous reactions were totally reversible between D2 and D3. On the cutaneous structure, slight dryness was noted on the treated area, from D2 in two animals and from D3 in the last one. Slight dryness was still noted at the end of the observation time (D14) in two animals.
The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.3 / 0.3 / 1 for erythema and 0.0/ 0.7/ 0.7 for oedema.
Therefore, the test material is not classified as irritant to the skin according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.
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