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EC number: 202-888-7 | CAS number: 100-79-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From to 21 July 2009 06 November 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 405 without major deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 24 February 2009
Test material
- Reference substance name:
- 2,2-dimethyl-1,3-dioxolan-4-ylmethanol
- EC Number:
- 202-888-7
- EC Name:
- 2,2-dimethyl-1,3-dioxolan-4-ylmethanol
- Cas Number:
- 100-79-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- (2,2-dimethyl-1,3-dioxolan-4-yl)methanol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report): PEX-01; 2,2-Dimetil-4-Hidroximetil-1,3-Dioxolano
- Physical state: Clear liquid
- Analytical purity: 99.5%
- pH of test substance = 6
- Composition of test material, percentage of components: 99.9% 2,2-Dimethyl-1,3-dioxolane-4-methanol; water: 0.02%; Acidity (Acetic acid): 0.0021%
- Lot/batch No.: 081001
- Expiration date of the lot/batch: 01 October 2009
- Stability under test conditions: Stable at room temperature and under normal conditions of use
- Storage condition of test material: at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Natanael Alves Ferreira, São Roque - SP
- Age at study initiation: Approximately 3 months
- Weight at study initiation: At least 1.5 kg
- Housing: galvanized metal cages (Gaiolas Ipanema, 50 x 50 x 50 cm)
- Diet: Commercial diet for the species (Guabi, Santa Fé), ad libitum
- Water: filtered water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: from 18ºC to 22ºC
- Humidity: 70%
- Air changes: No data
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: 08 September 2009 To: 29 September 2009.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye, which remained untreated, was used as the negative control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test item - Duration of treatment / exposure:
- Washing of treated eyes 24 hours following application
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye of the animals were rinsed after scoring with deionised water 24 hours following application
SCORING SYSTEM: According to the Draize method (OECD, 2002)
TOOL USED TO ASSESS SCORE:
- Observations at 24 hours, 48 hours, 72 hours, 7 days, 14 days and 21 days were performed with the aid of fluorescein to detect possible corneal abnormalities which are not grossly observable. Following an approximate 15 seconds exposure, both eyes were rinsed with water and further observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- - Signs of ocular irritation were observed at 1h, 24h, 48h, 72h, 7d and 14d.
- At 1h of observation, all animals presented opacity, conjunctivae redness and chemosis and two animals presented iritis.
- At 24 hours, all animals presented corneal opacity, conjunctival redness, chemosis and iritis. - At 48 hours, two animals presented opacity, iritis and chemosis and all animals presented conjunctivae redness.
- At 72 hours, all animals presented conjunctivae redness, two animals presented opacity and chemosis and one animal presented iritis.
- On day 7, ocular reactions were reverted in one animal, one animal presented chemosis and conjunctivae redness and one animal presented corneal opacity.
- On day 14, one animal presented conjunctivae redness and one animal presented opacity.
- All ocular reactions reverted on day 21. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Results of eye irritation
Rabbit Nº |
Time |
Opacity |
Area |
Iritis |
Conjunctival redness |
Chemosis |
1 |
1h |
1 |
1 |
0 |
2 |
3 |
24h |
1 |
1 |
1 |
2 |
1 |
|
48h |
0 |
0 |
0 |
1 |
0 |
|
72h |
0 |
0 |
0 |
1 |
0 |
|
7d |
0 |
0 |
0 |
0 |
0 |
|
14d |
0 |
0 |
0 |
0 |
0 |
|
21d |
0 |
0 |
0 |
0 |
0 |
|
2 |
1h |
1 |
1 |
1 |
2 |
3 |
24h |
1 |
3 |
1 |
2 |
1 |
|
48h |
1 |
2 |
1 |
2 |
1 |
|
72h |
1 |
1 |
1 |
2 |
1 |
|
7d |
0 |
0 |
0 |
1 |
1 |
|
14d |
0 |
0 |
0 |
1 |
0 |
|
21d |
0 |
0 |
0 |
0 |
0 |
|
3 |
1h |
1 |
1 |
1 |
2 |
3 |
24h |
1 |
3 |
1 |
2 |
1 |
|
48h |
1 |
3 |
1 |
2 |
1 |
|
72h |
1 |
2 |
0 |
2 |
1 |
|
7d |
1 |
1 |
0 |
0 |
0 |
|
14d |
1 |
1 |
0 |
0 |
0 |
|
21d |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, PEX-01 is classified as Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) N° 1272-2008 (CLP) and Category 2A (H319: Causes serious eye irritation) according to GHS UN.
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted submitted substance 2,2-Dimethyl-1,3-dioxolane-4-methanol in their left eye while the right eye remained untreated and served as control. The treated eye of the animals was rinsed after scoring with deionised water 24 hours following application. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and up to Day 21 after treatment and graded according to the Draize method.
Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
. corneal opacity: 0.3, 1 and 1
. iris lesions: 0.3, 1 and 0.7
. redness of the conjunctiva: 1.3, 2 and 2
. chemosis: 0.3, 1 and 1
Signs of ocular irritation were observed at 1h, 24h, 48h, 72h, 7d and 14d. All ocular reactions reverted on day 21. In this study, 2,2-Dimethyl-1,3-dioxolane-4-methanol is an eye irritant on male rabbits.
Under the test conditions, 2,2-Dimethyl-1,3-dioxolane-4-methanol is classified as Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) N° 1272-2008 (CLP) and Categor 2A (Cause serious eye irritation) according to GHS UN.
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