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EC number: 944-610-3 | CAS number: 286472-48-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- This study was conducted between 16 June 2016 and 30 June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- EC No. 440/2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethoxy-1,3-dimethylcyclohexane
- EC Number:
- 944-610-3
- Cas Number:
- 286472-48-8
- Molecular formula:
- C10H20O
- IUPAC Name:
- 2-ethoxy-1,3-dimethylcyclohexane
- Test material form:
- liquid
- Details on test material:
- - Substance name as cited in test report: FRET 05-0293
- Phystical state: clear, colorless liquid
- Storage conditions: ambient temperature (15-25 °C), protected from light
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hsdlf:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Leicestershire, UK
- Age at study initiation: 12 - 52 weeks
- Weight at study initiation: 3.21 - 3.62 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23”C
- Humidity (%): 30 - 70%
- Air changes (per hr): >15
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 16 JUne 2016 To: 30 June 2016
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL test substance as supplied
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 Days
- Number of animals:
- 2
- Details on study design:
- Study Design
On the day before the test each of a group of two rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar
formation preventing grading of erythema 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and
extending beyond the area of exposure) 4
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.
Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: 1 and 2
- Time point:
- other: 24 and 72 hours
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- fully reversible
- Other effects:
- Skin Reactions
The individual scores for erythema/eschar and edema are given in Table 1.
Well-defined erythema and slight edema were noted at one treated skin site with very slight erythema and slight edema noted at the other treated skin site immediately and 1 hour after patch removal. Well-defined erythema and slight edema were noted at both treated skin sites at the 24, 48, 72-Hour and 7 Day observations.
Loss of skin elasticity was noted at both treated skin sites at the 72 Hour observation and crust formation was noted at both treated skin sites at the 7 Day observation. Slight desquamation was noted at both treated skin sites at the 14 Day observation.
No corrosive effects were noted.
Body Weight
Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table: Individual Skin Reactions
Skin Reaction | Observation Time (following patch removal) |
Individual Scores | Total | |
75475 Male | 75478 Male | |||
Erythema/Eschar Formation | Immediately | 2 | 1 | (3) |
1 Hour | 2 | 1 | (3) | |
24 Hours | 2 | 2 | 4 | |
48 Hours | 2 | 2 | (4) | |
72 Hours | 2Le | 2Le | 4 | |
7 Days | 2Cf | 2Cf | (4) | |
14 Days | 0D | 0D | (0) | |
Edema Formation | Immediately | 2 | 2 | (4) |
1 Hour | 2 | 2 | (4) | |
24 Hours | 2 | 2 | 4 | |
48 Hours | 2 | 2 | (4) | |
72 Hours | 2 | 2 | 4 | |
7 Days | 2 | 2 | (4) | |
14 Days | 0 | 0 | (0) | |
Sum of 24 and 72 Hour Readings (S) : 16 | ||||
Primary Irritation Index (S/4) : 16/4 = 4.0 |
||||
Classification : MODERATE IRRITANT |
||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- The test item produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
The test item meets the criteria for classification as a Mild irritant (Category 3) according to the Globally Harmonized System of Classification and Labelling of Chemicals.
The test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. - Executive summary:
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.
Results
A single 4 Hour, semi occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and slight edema. Other skin reactions noted were loss of skin elasticity, crust formation and slight desquamation. No corrosive effects were noted.
Conclusion
The test item produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
The test item meets the criteria for classification as a Mild irritant (Category 3) according to the Globally Harmonized System of Classification and Labelling of Chemicals.
The test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures
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