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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from October 1, 1984 to October 18, 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- well documented under GLP principle
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
- Principles of method if other than guideline:
- An area of about 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 mL/application of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. The patches were covered with an occlusive membrane and held in place for 6 hours by an adhesive tape. The treatment was repeated for 5 consecutive days. The skin reactions were evaluated 24 hours after each application.
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animal Strain: New Zealand white rabbits (KFM-NZW)
Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
Acclimatization period: 5 days
Group Size and Husbandry: The test was performed on 3 male rabbits , checked for normal skin conditions, weighing between 2 to 3 kg (approx. 12 - 14 weeks old) . The animals were housed individually in metal cages, identified with individually numbered ear tags, kept at a constant room temperature of 20 ±3 °C, at a relative humidity of 30 - 70% and on a 12 hours light cycle per day.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral flank
- Amount / concentration applied:
- 0.5 mL/application of test substance
- Duration of treatment / exposure:
- held in place for 6 hours, repeated for 5 consecutive days
- Observation period:
- the observation period was extended to 17 days.
- Number of animals:
- 3 males
- Details on study design:
- An area of about 6 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 mL/application of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. The patches were covered with an occlusive membrane and held in place for 6 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The treatment was repeated for 5 consecutive days. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 24 hours after each application according to the OECD scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- 24/48/72 h
- Score:
- ca. 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- see Table 1 and Table 2
- Other effects:
- No abnormal body weight gain was observed during the treatment period.
Any other information on results incl. tables
Table 1 Erythema
Animal No./sex |
28 M |
29M |
30M |
|||
|
CF |
TF |
CF |
TF |
CF |
TF |
After 1 days |
0 |
1 |
0 |
1 |
0 |
1 |
After 2 days |
0 |
2 |
0 |
2 |
0 |
2 |
After 3 days |
0 |
3 |
0 |
3 |
0 |
3 |
Mean 1-3 days |
0 |
2 |
0 |
2 |
0 |
2 |
After 4 days |
0 |
4 |
0 |
4 |
0 |
4 |
After 5 days |
0 |
4 |
0 |
4 |
0 |
4 |
Mean 1-5 days |
0 |
2.8 |
0 |
2.8 |
0 |
2.8 |
After 7 days |
0 |
2 |
0 |
3 |
0 |
3 |
After 10 days |
0 |
1 |
0 |
1 |
0 |
2 |
After 14 days |
0 |
0 |
0 |
0 |
0 |
0 |
After 17 days |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2 Edema
Animal No./sex |
28 M |
29M |
30M |
|||
|
CF |
TF |
CF |
TF |
CF |
TF |
After 1 days |
0 |
0 |
0 |
0 |
0 |
0 |
After 2 days |
0 |
2 |
0 |
1 |
0 |
2 |
After 3 days |
0 |
2 |
0 |
2 |
0 |
3 |
Mean 1-3 days |
0 |
1.3 |
0 |
1 |
0 |
1.66 |
After 4 days |
0 |
3 |
0 |
3 |
0 |
3 |
After 5 days |
0 |
3 |
0 |
2 |
0 |
3 |
Mean 1-5 days |
0 |
2 |
0 |
1.3 |
0 |
2.2 |
After 7 days |
0 |
2 |
0 |
3 |
0 |
3 |
After 10 days |
0 |
1 |
0 |
1 |
0 |
2 |
After 14 days |
0 |
0 |
0 |
0 |
0 |
0 |
After 17 days |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Criteria used for interpretation of results: EU CLP
- Conclusions:
- It can be concluded that test substance possess a cumulative skin irritation potential in albino rabbits.
- Executive summary:
A 5-day skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of test substance on the albino rabbit skin. Under the experimental conditions employed, test substance induced weak erythema reactions after 1 treatment and strong erythema and edema reactions after repeated application comparing with control treatment. The skin reactions were reversible until the end of the observation period on day 17. Therefore, test substance can be classified as category 2 of skin irritation in the rats according to CLP (Regulation EC No. 1272/2008).
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