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EC number: 224-436-8 | CAS number: 4359-47-1
- 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, other
- Remarks:
- Test performed before current guidelines
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted in September 1978.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 405, the guideline is not referenced and the study is non-GLP. However, this did not influence the reliability of the results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(1-ethylpentyl)-1,3-dioxolane
- EC Number:
- 224-436-8
- EC Name:
- 2-(1-ethylpentyl)-1,3-dioxolane
- Cas Number:
- 4359-47-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 2-(1-ethylpentyl)-1,3-dioxolane
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino strain
- Details on test animals or tissues and environmental conditions:
- The tests were carried out according to the classical Draize technique.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- Amount applied: 0.1 mL
- Duration of treatment / exposure:
- Single instillation on Day 1
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- STUDY DESIGN
The test material was applied at 100% in 3 animals.
TREATMENT
Similar and in accordance with OECD 405 (1981). The test substance is placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.
REMOVAL OF TEST SUBSTANCE
-Washing: No
OBSERVATIONS
- Irritation:
The eyes of each animal were examined at 1, 24, 48 and 72 hours and 4 and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, 2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 2, 3 (mean)
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal: #1, 2, 3
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hr
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 2
- Time point:
- other: 1 hr
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 hr
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Results:
Rabbit no. |
Observations |
1 hr |
24 hr |
48 hr |
72 hr |
7 days |
1 |
Cornea |
0,0=0 |
0,0=0 |
0,0=0 |
0,0=0 |
0,0=0 |
Iris |
0=0 |
0=0 |
0=0 |
0=0 |
0=0 |
|
Conjunctiva |
1,1,0=4 |
1,0,0=2 |
0,0,0=0 |
0,0,0=0 |
0,0,0=0 |
|
2 |
Cornea |
0,0=0 |
0,0=0 |
0,0=0 |
0,0=0 |
0,0=0 |
Iris |
0=0 |
0=0 |
0=0 |
0=0 |
0=0 |
|
Conjunctiva |
1,1,0=4 |
1,0,0=2 |
0,0,0=0 |
0,0,0=0 |
0,0,0=0 |
|
3 |
Cornea |
0,0=0 |
0,0=0 |
0,0=0 |
0,0=0 |
0,0=0 |
Iris |
0=0 |
0=0 |
0=0 |
0=0 |
0=0 |
|
Conjunctiva |
1,0,0=2 |
0,0,0=0 |
0,0,0=0 |
0,0,0=0 |
0,0,0=0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- According to EU CLP 1272/2008 and its amendments.
- Conclusions:
- In an eye irritation study with rabbits, performed comparable to OECD 405 (1981), essentially no irritation was observed. Based on the results of this study, the substance is not considered an eye irritant.
- Executive summary:
The substance was tested in an eye irritation test in rabbits comparable to OECD 405 (1981). Three New Zealand albino rabbits were used and the substance was used undiluted. The volume applied was 0.1 ml. Ocular effects included only a slight redness of conjunctiva in all 3 animals (score 1) at 1 hr, which were fully reversible within 24 hours in 1 animal and within 48 hours in 2 animals. A slight chemosis was observed in 2 animals (score 1) that was fully resolved within 24 hours. No other effects were seen. Based on the results of this study, the substance is not considered an eye irritant.
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