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EC number: 440-020-0 | CAS number: 61668-40-4
- 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:
- Between 02 October 2001 and 16 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols and under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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 (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 440-020-0
- EC Name:
- -
- Cas Number:
- 61668-40-4
- Molecular formula:
- C12H24O
- IUPAC Name:
- Dec-1-en-1-yl ethyl ether
- Test material form:
- other: clear colourless liquid
- Details on test material:
- Sponsor's identification: ARCTICAL
Chemical name: 1-decene, 1-ethoxy
CAS number: 61668-40-4
Purity: 97.8%
Stability: stable under nonnal temperatures and pressure
Description: clear colourless liquid
Batch number: ES 7565L/2
Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A reputable UK supplier
- Age at study initiation: Twelve to sixteen weeks old
- Weight at study initiation: 2.0 to 3 .5 kg
- Housing: Individually housed in suspended metal cages.
- Diet: Free access to food (Certified Rabbit Diet (Code 5322) supplied by a reputable UK supplier
- Water: Free access to mains drinking water
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Humidity: 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour
- Photoperiod: Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of the test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animalswith 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 material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. 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 returnedto their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cottonwool soaked in 74% Industrial Methylated Spirits.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #37
- Time point:
- other: Mean of scores at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: Moderate desquamation and reduced regrowth of fur observed at 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal: #43
- Time point:
- other: Mean of scores at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Crust formation and reduced regrowth of fur observed at 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal: #49
- Time point:
- other: Mean of scores at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: Moderate desquamation and reduced regrowth of fur observed at 14 d
- Irritation parameter:
- edema score
- Basis:
- animal: #37
- Time point:
- other: Mean of scores at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal: #43
- Time point:
- other: Mean of scores at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal: #49
- Time point:
- other: Mean of scores at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- Well-defined erythema was noted at all treated skin sites one hour after patch removal and persisted at all treated skin sites at the 24. 48 and 72-hour observations. Other reactions noted were light brown discolouration of the epidermis, skin reactions extending approximately 4 cm beyond the site of application. loss of skin elasticity, crust formation. moderate desquamation and reduced re growth of fur. Adverse reactions prevented the evaluation of erythema at the 7 -day observation.
Very slight to slight oedema was noted at all treated skin sites one hour after patch removal with slight oedema noted at all treated skin sites at the 24, 48 and 72-hour observations. Adverse reactions prevented evaluation of oedema at the 7-day observation.
Any other information on results incl. tables
Individual Skin Reactions
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
37 Female |
43 Male |
49 Male |
|||
ErythemalEschar Formation |
1 Hour |
2 |
2 |
2 |
(6) |
24 hours |
2 R |
2 Br |
2 R |
6 |
|
48 Hours |
2 RLe |
2 BrLe |
2 RLe |
(6) |
|
72 Hours |
2 RLe |
2 BrLe |
2 RLe |
6 |
|
7 Days |
?eCf |
?eCf |
?eCf |
(0-12) |
|
14 Days |
0 DFr |
0 CfFr |
0 DFr |
(0) |
|
Oedema Formation |
1 Hour |
1 |
2 |
2 |
(5) |
24 hours |
2 |
2 |
2 |
6 |
|
48 Hours |
2 |
2 |
2 |
(6) |
|
72 Hours |
2 |
2 |
2 |
6 |
|
7 Days |
?od |
?od |
?od |
(0-12) |
|
14 Days |
0 |
0 |
0 |
(0) |
|
Sum of 24 and 72-hour Readings (S): |
24 |
||||
Primary Irritation Index (S/6): |
24/6 = 4.0 |
||||
Classification: |
MODERATE IRRITANT |
( ) = Total values not used for calculation of primary irritation index
Br = Light brown discolouration of the epidermis
Cf= Crust formation
D = Moderate desquamation
Fr = Reduced regrowth of fur
Le = Loss of skin elasticity
R = Reaction extends beyond site of application
?e = Adverse reactions prevent evaluation of erythema
?od = Adverse reactions prevent evaluation of oedema
Interpretation of Results
Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme
The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material. The test material was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the,,, p.47:
Primary Irritation Index |
Classification of Irritancy |
0 |
Non-irritant |
> 0 to 2 |
Mild irritant |
> 2 to 5 |
Moderate irritant |
> 5 to 8 |
Severe irritant |
If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Category 2: Irritant Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 4. 0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
The irritant effects of Arctical to rabbit skin was assessed in a GLP study according to OECD Guideline No. 404. A quantity of 0.5 ml of test substance was applied to the intact skin of three rabbits. Four hours after application the corset and patches were removed from each animal. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of irritation and scored. Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions. In accordance with the classification criteria set out in CLP Regulation (EC) 1272/2008 the test material is considered to be Category 2: Irritant
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