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EC number: 457-690-5 | CAS number: 23432-65-7
- 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
Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating
Respiratory irritation: no data available
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:
- 03 - 25 Nov 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 3200 - 3400 g
- Fasting period before study: no
- Housing: housed in ABS-plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free, ad libitum
- Water: tap water, ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 24, 48 and 72 h - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze patch held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: residual test item was washed up with cottonseed oil
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- 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
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reactions were observed in any animal at any time point.
- Other effects:
- No signs of systemic toxicity nor effects on body weight were observed.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In a skin irritation study according to OECD 404 (GLP compliant) the substance was found to be not irritating to skin. Treatment of 3 female New Zealand White rabbits under semi-occlusive conditions with 0.5 mL undiluted test substance induced no skin reactions in any animal at any time point. Furthermore no signs of systemic toxicity nor effects on body weight were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Nov - 02 Dec 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: 3800 - 4300 g
- Fasting period before study: no
- Housing: housed in ABS-plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free, ad libitum
- Water: tap water, ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume with unit): 0.1 mL - Duration of treatment / exposure:
- single instillation without washing
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM:
Draize scoring system
TOOL USED TO ASSESS SCORE: at the end of the observation period the eyes were examined with the aid of fluorescein solution - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- No effects on cornea and iris were observed in any animal at any time point. Slight redness (grade 2) and chemosis (grade 1-2) was observed 1 h after instillation of the test substance. Redness and chemosis were fully reversible within 6 days and 24/48 h, respectively. Slight discharge (grade 1-2) was observed in all 3 animals 1 h after instillation only.
- Other effects:
- No signs of systemic toxicity or effects on body weight gain were observed.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- In an eye irritation study according to OECD 405 (GLP compliant) the substance was found to be not irritating to eyes. Treatment of 3 female New Zealand White rabbits with 0.1 mL undiluted test substance resulted in no effects on cornea and iris in any animal at any time point. Slight conjunctival redness (grade1-2) and chemosis (grade 1-2) were observed, but were fully reversible within 6 days at the latest. Furthermore no signs of systemic toxicity nor effects on body weight were observed.
Reference
Table 1: Individual scores from eye irritation study in rabbits.
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
2 |
1 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
1.0 |
0 |
0 |
0 |
|
2
|
1 |
2 |
2 |
0 |
0 |
24 |
2 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
96 |
1 |
0 |
0 |
0 |
|
120 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
1.33 |
0.33 |
0 |
0 |
|
3
|
1 |
2 |
1 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
96 |
1 |
0 |
0 |
0 |
|
120 |
1 |
0 |
0 |
0 |
|
144 |
0 |
0 |
0 |
0 |
|
average (over 24, 48, 72 h) |
1.33 |
0 |
0 |
0 |
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
A key skin irritation study with methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) is available and was performed according to OECD TG 404 and in compliance with GLP (BSL, 2003). In the study three female New Zealand White rabbits were exposed to 0.5 mL of the neat test material for 4 hours applied onto the clipped skin via semi-occlusive dressing. Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. No mortalities occurred and no remarkable body weight changes were observed during the study period. The test article did not induce any skin reactions in any animal during the study period. Furthermore no signs of systemic toxicity were observed. Based on the results of the study the test item should be considered as non-irritating.
Eye irritation
A key eye irritation
study performed according to OECD TG 405 and in compliance with GLP with
methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) is
available (BSL, 2003). For the assessment of the eye irritation
properties 0.1 mL of the test substance was instilled in the eye of
three female New Zealand White rabbits. The eyes were examined and the
changes were graded according to the Draize scoring system 1, 24, 48 and
72 hours and up to 6 days post-application. No effects on cornea and
iris were observed in any animal at any time point. Slight redness
(grade 2) and chemosis (grade 1-2) were observed in all animals 1 h
after instillation of the test substance. Mean values of redness and
chemosis of each animal between 24, 48 and 72 hours post-application
were 1.0, 1.33, 1.33 and 0, 0.33, 0, respectively. Redness and chemosis
were fully reversible within the observation period. No remarkable body
weight changes and no signs of
systemic toxicitywere noted
during the study period. Based on the study results and according to EU
classification criteria, the test substance is considered to be
non-irritating.
Justification for classification or non-classification
The available data on skin and eye irritation of Methyl-N-{[dimethoxy(methyl)silyl]methyl}carbamate (CAS 23432-65-7) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.
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