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EC number: 219-553-6 | CAS number: 2461-15-6
- 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 September 29, 1983 to October 10, 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- [[(2-ethylhexyl)oxy]methyl]oxirane
- EC Number:
- 219-553-6
- EC Name:
- [[(2-ethylhexyl)oxy]methyl]oxirane
- Cas Number:
- 2461-15-6
- Molecular formula:
- C11H22O2
- IUPAC Name:
- 2-{[(2-ethylhexyl)oxy]methyl}oxirane
- Test material form:
- other: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Experimental animals:
Rationale
The albino rabbit has been selected as being a recognized species for the conduct of acute eye irritation studies.
Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
Initial age range: 12 - 14 weeks
Initial body weight range: 2000 - 2310 g
Individual identification: numbered ear tags; The cages were marked with sex, animal No., GU-Project No. and the company code of the
test article.
Husbandry: Animals were housed individually in metal cages. The animal room was air conditioned: temperature 20 ±3 ° C, relative humidity 30 - 70%; 12 hours light/day, approximately 15 air changes/h.
Diet and water: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.
Euthanasia: At the end of the observation period, the animals were killed by the intravenous injection of hypnotic T61 (Hoechst).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated and served as the control
- Amount / concentration applied:
- 0.1 mL of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material.
- Duration of treatment / exposure:
- 1 second
- Observation period (in vivo):
- The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- The ocular irritation scores were evaluated according to the scoring system.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect.
Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays).
Body weight: At begin of the acclimatisation and end of test
Mortality: Daily (a.m. and p.m. on working days, once daily on weekends and holidays).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritant / corrosive response data:
- The reaction scores of treated eyes are summarized in the table 1 and table 2 below.
- Other effects:
- The animals showed a normal body weight development.
No other reactions to treatment were recorded during the whole observation period.
Any other information on results incl. tables
Table 1 individual eye scores
Animal No./Sex |
54/F |
55/F |
56/F |
Evaluation |
After 1 h |
0 |
0 |
0 |
0= non irritant 1= slightly irritant 2= irritant 3-4 = severely irritant += corrosion Cornea |
After 24 h |
0 |
0 |
0 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
|
After 1 h |
0 |
0 |
0 |
0= non irritant 1= irritant 2= severely irritant += corrosion Iris |
After 24 h |
0 |
0 |
0 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
|
After 1 h |
1 |
2 |
2 |
0= non irritant 1= slightly irritant 2= irritant 3= severely irritant += corrosion Conjuctival(redness) |
After 24 h |
0 |
1 |
1 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
|
After 1 h |
1 |
1 |
1 |
0= no swelling 1= slightly swelling 2= swelling 3-4 = severe swelling Chemosis(swelling) |
After 24 h |
0 |
0 |
0 |
|
After 48 h |
0 |
0 |
0 |
|
After 72 h |
0 |
0 |
0 |
|
After 7 days |
0 |
0 |
0 |
Table 2 Mean value of 24 -72 hrs
|
Cornea |
Iris |
conjuctiva |
chemosis |
54/F |
0 |
0 |
0 |
0 |
55/F |
0 |
0 |
0.33 |
0 |
56/F |
0 |
0 |
0.33 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU CLP
- Conclusions:
- It can be concluded that test substance is slightly irritant and not corrosive when applied to the rabbit eye mucosa; there was a clear tendency of recovery towards the end of the observation period.
- Executive summary:
Acute eye irritation study was established to assess the potential of eye irritation of test substance. 0.1 mL of the test article was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period. The animals showed a normal body weight development. No other reactions to treatment were recorded during the whole observation period. Because the mean values of the readings 24 to 72 hours after instillation of test substance are below the threshold of significance, and there was a clear tendency of recovery towards the end of the observation period the test substance does not require classification for eye effects in accordance with CLP (Regulation EC No. 1272/2008).
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