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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
nonapotassium 2,4,6-trihydroxy-4-methyl-3,5-dioxa-2,4,6-trisilaheptane-2,6-bis(olate) 2,6,8-trihydroxy-4,6-dimethyl-3,5,7-trioxa-2,4,6,8-tetrasilanonane-2,4,8-tris(olate) 6-hydroxy-2,4,6-trimethyl-1,3,5,2,4,6-trioxatrisilinane-2,4-bis(olate) dihydroxy(methyl)silanolate {[dihydroxy(methyl)silyl]oxy}(hydroxy)methylsilanolate
EC number: 935-877-7 | 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
Endpoint summary
Administrative data
Description of key information
Based on the available in vivo and in vitro data the following conclusion can be drawn: reaction mass of potassium methylsiliconate is not irritating to the skin but is expected to cause serious eye damage.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 14-29, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline and in compliance with GLP.
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 23 weeks old
- Weight at study initiation: >2 kg
- Housing: semi-barrier in an air-conditioned room, ABS-plastic rabbit cages, floor 4200 cm²
- Diet (e.g. ad libitum): free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): artificial light, sequence being 12 hours light, 12 hours dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A dose of 0.5 g of the test item was applied to each test site.
- Duration of treatment / exposure:
- The test item was held in contact with the skin throughout a 4-hour period.
At the end of the exposure period, the residual test item was removed with tap water. - Observation period:
- All animals were observed for 72 hours after the patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The gauze was held in place with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the residual test item was removed with tap water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- Erythema and Eschar Formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beef redness) to eschar formation preventing grading of erythema
- 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 exposure area) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals #1-3
- Time point:
- other: mean 24-72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals #1-3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritant or corrosive effects were observed on the intact skin of the three female rabbits (strain NZW) after a contact time of 4 hours.
In animal no 3 the test item showed slightly irritant (erythema grade 1) effects 48 hours after patch removal which were fully reversible within 72 hours. - Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, the single dermal application of the test item at a dose of 0.5 g showed slightly irritant but no corrosive
effects which were fully reversible within 72 hours after patch removal in one out of three animals. Neither irritant nor corrosive effects were observed in any other animal. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to GHS (Globally Harmonized Classification System), the test item has no obligatory labelling requirement for skin irritation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 13-15, 2014
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Amount / concentration applied:
- Enough test substance to cover the whole cornea was applied directly onto the cornea by removing the window-locking ring and glass window prior to treatment and moistened with physiological saline 0.9%.
- Details on study design:
- TEST GROUPS:
- 3 corneas for the test item
- 3 corneas as negative controls treated with physiological saline 0.9% NaCl
- 3 corneas as positive control treated with imidazole 20% in physiological saline 0.9% NaCl
SCORING SYSTEM (Evaluation of the BCOP Assay):
The IVIS cut-off values for identifying test substances as inducing serious eye damage (UN GHS Category 1) and test substances not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are as fllows:
- Mean score ≤ 3: no category
- Mean score >3; ≤ 55: no prediction can be made
- Mean score >55: Category 1
An identification of test substances that should be classified as irritating to eyes (UN GHS Category 2 or Category 2A) or test substances that should be classified as mildly irritating to eyes (UN GHS Category 2B) cannot be made. - Irritation parameter:
- other: bovine corneal opacity and permeability
- Time point:
- other: not applicable
- Score:
- 313.15
- Reversibility:
- other: not applicable
- Remarks on result:
- other: in-vitro test
- Irritant / corrosive response data:
- The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The test item was tested as provided by the sponsor. The following mean in vitro irritation score was calculated: 313.15.
Therefore the test item was classified into UN GHS Category 1.
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid. - Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- According to the evaluation criteria the test item is classified into UN GHS Category 1.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The substance is a multi-constituent substance containing methylsilanetriolate, dimers and trimers of methylsilanetriolate, and potassium hydroxide. The substance dissolves in contact with water resulting in an aqueous alkaline solution (pH 13-14) with corrosive properties.
Effects on eye irritation: corrosive
Justification for classification or non-classification
Based on the available data of the substance as supplied, reaction mass of potassium methylsiliconate is classified as R41 "Risk of serious damage to eyes" according to the criteria of EU Directive 67/548/EEC and "Eye Dam. Cat. 1" under Regulation 1272/2008.
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.