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EC number: 939-623-6 | CAS number: -
- 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:
- 14 November - 14 December 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 404 with minor deviation: the temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges; individual animal weights not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol and alpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]
- Cas Number:
- 63727-39-9
- Molecular formula:
- C15H31ClO2 C18H36Cl2O3 C21H41Cl3O4
- IUPAC Name:
- reaction mass of 1-chloro-3-(dodecyloxy)propan-2-ol and alpha-dodecyl-omega-hydroxy-di[oxy[(chloromethyl)-1,2-ethanediyl]] and alpha-dodecyl-omega-hydroxy-tri[oxy[(chloromethyl)-1,2-ethanediyl]]
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Thick colorless to pale yellow liquid
- Date of receipt: 12 October 2006
- Expiration date of the lot/batch: 04 October 2007
- Storage condition of test material: Room temperature
- pH of the undiluted test item, measured (paper pH), was approximately 1.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., Roussay, France.
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.8 ± 0.3 kg
- Housing: Animals were housed individually in Pajon cages (50 cm x 57 cm x 75 cm).
- Diet: Control Reference 110 pelleted diet (SAFE, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test item - Duration of treatment / exposure:
- First animal: 3 minutes, 1 and 4 h
Second and third animal: 4 h - Observation period:
- 15 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Flank region
- Type of wrap if used: Undiluted test item was placed on a dry gauze pad, which was then applied to an area of approximately 6 cm^2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 h) and the posterior right flank (application for 4 h) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- After removal of the dressing applied for 3 minutes, any residual test item was wiped off by means of a dry cotton pad. No residual test item was observed on removal of the dressing applied for 1 or 4 h.
- Time after start of exposure: 4 h
SCORING SYSTEM: According to OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - After a 3-minute exposure (one animal), very slight or well-defined erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 5 until Day 15 (end of the observation period).
- After a 1-h exposure (one animal), very slight to moderate erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 4 until Day 15 (end of the observation period).
- After a 4-h exposure (three animals), well-defined to moderate erythema was noted in all the animals from Day 1 until Day 7 (2 animals) or Day 9 (1 animal) then very slight erythema persisted until Day 9 (1 animal) or Day 14 (2 animals). Dryness of the skin was recorded in all the animals between Day 4 and Day 15 (end of the observation period). - Other effects:
- None
Any other information on results incl. tables
The test item was first evaluated on a single animal (No. 730). The durations of exposure were 3 minutes, 1 and 4 h. Since the test item was irritant but not corrosive on this first animal, it was then applied sequentially for 4 h to two other animals (No. 750 then No. 749).
See attached Document for Tables of Results
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test item is classified as "R38: irritating to skin" according to the criteria of Annex VI to the Directive 67/548/EEC and classified "Category 2: irritant" according to CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a GLP-compliant primary dermal irritation study performed according to OECD Guideline 404, three male New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted test item under a semi-occlusive dressing. The test item was first evaluated on a single animal and the duration of exposure was 3 minutes, 1 and 4 h on the flank region. Since the test item was irritant but not corrosive on this first animal, it was then applied sequentially for 4 h to two other animals. After removal of the residual test item, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h and up to 15 days after exposure.
After a 3-minute exposure (one animal), very slight or well-defined erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 5 until Day 15 (end of the observation period). After a 1-h exposure period (one animal), very slight to moderate erythema was noted from Day 1 until Day 8. Dryness of the skin was observed from Day 4 until Day 15 (end of the observation period). After a 4-h exposure (three animals), a well-defined to moderate erythema was noted in all the animals from Day 1 until Day 7 (2 animals) or Day 9 (1 animal) then a very slight erythema persisted until Day 9 (1 animal) or Day 14 (2 animals). Dryness of the skin was recorded in all the animals between Day 4 and Day 15 (end of the observation period). Mean scores over 24, 48 and 72 h for each animal were 2.7, 2.0 and 2.0 for erythema and 0.0, 0.0 and 0.0 for edema. The test item is therefore a skin irritant on male rabbits.
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