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EC number: 261-332-1 | CAS number: 58567-11-6
- 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 1994-10-18 to 1994-12-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (ethoxymethoxy)cyclododecane
- EC Number:
- 261-332-1
- EC Name:
- (ethoxymethoxy)cyclododecane
- Cas Number:
- 58567-11-6
- Molecular formula:
- C15H30O2
- IUPAC Name:
- (ethoxymethoxy)cyclododecane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97633 Sulzfeld.
- Age at study initiation: not reported
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: individual caging in metal wire cages
- Diet (e.g. ad libitum): Altromin 2023 diet for rabbits, ad libitum
- Water (e.g. ad libitum): tap water from an automatic watering system, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5
- Humidity (%): 50 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 1994-10-18
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Hair was clipped on the dorsal area of the trunk one day before the application
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after patch removal. Additional examinations 6, 8 and 10 days after patch removal.
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: median on the dorsal thoracal region
- % coverage: test substance spread over an area of approximately 6 cm2
- Type of wrap if used: plastic collar
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off using wet cellulose tissue
- Time after start of exposure: 4 hours
SCORING SYSTEM:
ERYTHEMA/ESCHAR FORMATION
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) or eschar formation (injuries in depth)
OEDEMA FORMATION
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well defined by definite raising)
3: Moderate oedema (raised approximately 1 mm)
4: Severe oedema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of scores at 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Other effects:
- Animal 1: Eschar formation after 72 hours. Eschar almost completely desquamated after 6 days and completely desquamated after 8 days, with intact skin below.
Animal 2: No additional observations.
Animal 3: Eschar on four sites, diameter approximately 1 mm each from 48 hours to 8 days. On day 8, eschar completely desquamated, intact skin below.
Any other information on results incl. tables
Scores of the application sites
Time after the end of exposure |
Erythema / Eschar formation |
Oedema formation |
||||
Animal No |
1041 |
1042 |
1043 |
1041 |
1042 |
1043 |
1 h |
2 |
2 |
2 |
3 |
3 |
3 |
24 h |
2 |
2 |
3 |
3 |
2 |
4 |
48 h |
4 |
2 |
4 |
4 |
2 |
4 |
72h |
4 |
2 |
4 |
4 |
2 |
4 |
mean(24-72h) |
3.3 |
2.0 |
3.7 |
3.7 |
2.0 |
4.0 |
6 d |
2 |
1 |
4 |
2 |
1 |
4 |
8 d |
0 |
0 |
1 |
0 |
0 |
2 |
10 d |
|
|
0 |
|
|
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: EU CLP criteria
- Remarks:
- Skin irritating (Category 2)
- Conclusions:
- The substance is irritating to the skin.
- Executive summary:
The potential of the substance to induce skin irritation was investigated in a GLP study in conformance with OECD TG 404.
0.5 mL test substance was applied to the intact skin of 3 rabbits in a semi-occlusive application. After 4 hours, residual test substance was wiped off. Animals were examined for erythema/eschar and oedema as well as for other local and systemic signs approximately 1, 24, 48 and 72 hours after patch removal. Additional examinations were performed 6, 8 and 10 days after patch removal. The mean of the erythema/eschar scores at 24, 48 and 72 hours was 3.3, 2.0 and 3.7 in animal 1, 2 and 3, respectively.
The mean of the oedema scores at 24, 48 and 72 hours was 3.7, 2.0 and 4.0. Scores returned to "0", i. e. normal, within 8 days after patch removal in 2/3 animals respectively within 10 days after the end of exposure in the third animal.
In conclusion, the substance has to be regarded as irritating to the skin.
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