Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-491-7 | CAS number: 141-62-8
- 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:
- 23 January 2009 to 3 March 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Decamethyltetrasiloxane
- EC Number:
- 205-491-7
- EC Name:
- Decamethyltetrasiloxane
- Cas Number:
- 141-62-8
- Molecular formula:
- C10H30O3Si4
- IUPAC Name:
- 2,2,4,4,6,6,8,8-octamethyl-3,5,7-trioxa-2,4,6,8-tetrasilanonane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data available
- Age at study initiation: approximately 4 months
- Weight at study initiation: 2660 to 2789 g
- Housing: individually
- Diet (e.g. ad libitum): standard diet, provided as recommended by animal vendor
- Water (e.g. ad libitum): purified municipal water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 to 20.6
- Humidity (%): 51 to 62
- Air changes (per hr): 13.1
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23 January 2009 To: 30 January 2009
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- Pilot study: 3 min, 1 hour, 4 hours (1 animal, three sites)
Confirmatory study: 4 hours (2 animals, 1 site/animal) - Observation period:
- Pilot study: for 3-minute and 1-hour treatments, observation at 0 hours after patch removal; for 4-hour treatment, observations at 60 ± 5 min, 24 ± 2 hours, 48 ± 2 hours and 72 ± 2 hours after patch removal
Confirmatory study: for 4-hour treatment, observations at 60 ± 5 min, 24 ± 2 hours, 48 ± 2 hours and 72 ± 2 hours after patch removal - Number of animals:
- 1 male (pilot study)
2 males (confirmatory study) - Details on study design:
- TEST SITE
- Area of exposure: no data available
- % coverage: no data available
- Type of wrap if used: coverlet wrapped by a layer of gauze bandage followed by a layer of elastic wrap (Elastoplast (R)). Animals were fitted with Elizabethan collars for at least 24 hours to prevent removal of bandaging.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance removed following exposure period with water-moistened gauze, and dry gauze
- Time after start of exposure: presumably 3 mins, 1 hour or 4 hours
SCORING SYSTEM: EEC Primary Irritation Index (PII); EPA Primary Irritation Index (PII)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- EEC
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- EEC
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: overall
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of dermal irritation (erythema or oedema) were seen at any observation time point in any animal.
- Other effects:
- No dermal lesions or additional dermal findings were noted during the experimental phase. No remarkable changes in body weight were observed (mean body weight change of 30.7 with standard deviation 7.77). No animals died during the course of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP study performed according to OECD Test Guideline 404, decamethyltetrasiloxane (L4) was non-irritating to the skin of three rabbits when applied undiluted semi-occluded for 4 hours.
- Executive summary:
In an acute dermal irritation/corrosion study carried out to GLP and according to OECD Test Guideline 404, rabbits were exposed dermally to decamethyltetrasiloxane (L4).
In a pilot study, 0.5 ml of the undiluted test substance was applied under occlusion to the shaved, intact skin of one male rabbit for three minutes or one hour. The test site was scored immediately after patch removal. The confirmatory study involved the treatment of the same animal, and two additional males, with the undiluted test substance under occlusion for four hours. Animals were observed at approximately 1, 24, 48 and 72 hours after patch removal.
No signs of dermal irritation or any other toxic effect were seen over the course of the study.
Under these experimental conditions, undiluted decamethyltetrasiloxane (L4) was non-irritating to the skin of rabbits when applied for up to four hours.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.