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EC number: 217-370-6 | CAS number: 1825-62-3
- 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
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:
- 07 - 17 May 2002
- 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 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 4.5 and 5.5 months
- Weight at study initiation: 2.1-2.3 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. During exposure the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 June 2002 To: 22 Aug 2002 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 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 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: Test site covered with a gauze patch, which was held in contact to the skin by means of a semi-occlusive dressing (non-irritating tape).
REMOVAL OF TEST SUBSTANCE
No residual test substance was removed.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- 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
- Irritant / corrosive response data:
- Erythema grade 1 (3/3 animals) were observed 60 min and 24 h after patch removal. Erythema reactions were fully reversible within 48 h. No oedema reactions were observed in any animal. No other findings 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 with ethoxy(trimethyl)silane (according to OECD 404, GLP compliant) the substance was found to be not irritating. Treatment of 3 male Himalayan rabbits under semi-occlusive conditions with 0.5 mL undiluted test substance only provoked slight erythema reactions being fully reversible within 48 h. Mean erythema and oedema scores over 24, 48, and 72 h were 0.33 and 0, respectively.
Reference
Table 1: Individual results of the skin irritation test.
Rabbit No. |
1 |
2 |
3 |
|||
Observation time |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
1 |
0 |
1 |
0 |
1 |
0 |
24 h |
1 |
0 |
1 |
0 |
1 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
0.33 |
0 |
0.33 |
0 |
0.33 |
0 |
24 + 48 + 72 h |
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:
- 07 - 19 May 2002
- 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 Feb 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT, Laboratory of Pharmacology and Toxicology KG, Loehndorf, Germany
- Age at study initiation: approximately 11 months
- Weight at study initiation: 2.3-2.6 kg
- Fasting period before study: no
- Housing: Single housing before and after the exposure period. For 8 h following the test substance application the animals were kept singly in restrainers, which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine.
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55± 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without rinsing
- Observation period (in vivo):
- 72 h
Reading time points: 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
The test substance was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, and 72 hours after the administration. 24 h after administration the eyes were treated additionally with fluorescein and examined. - Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean of 3 animals
- 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:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- 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
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- 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. After 1 h redness (grade 1) was observed in all 3/3 animals and was fully reversible within 48 h. After 1 h chemosis grade 1 (1/3) and grade 2 (2/3) was observed and was fully reversible within 48 h. No other findings were reported.
- Other effects:
- No systemic intolerance reactions 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 with ethoxy(trimethyl)silane (according to OECD 405, GLP compliant) the substance was found to be not irritating. Treatment of 3 male Himalayan rabbits with 0.1 mL undiluted test substance only provoked slight redness and chemosis being fully reversible within 48 h. No effects on iris and cornea were observed. Mean conjunctivae and chemosis scores over 24, 48, and 72 h were 0, 0.33, 0.33 and 0, 0.33, 0.33, respectively, for the individual animals.
Reference
Table 1: Individual results of the eye irritation study in rabbits.
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
1 |
1 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0 |
0 |
0 |
0 |
|
2
|
1 |
1 |
2 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
0.33 |
0 |
0 |
|
3
|
1 |
1 |
2 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
0.33 |
0 |
0 |
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
A skin irritation test is available with ethoxy(trimethyl)silane (CAS 1825-62-3), which was performed in Himalayan rabbits according to OECD 404 and in compliance with GLP (LPT, 2002). Neat test substance (0.5 mL) was applied to a 6 cm² application site (shaved) for 4 h under semi-occlusive conditions. No residual test substance was removed. Sixty minutes and 24, 48, 72 h after patch removal the application site was examined. Erythema (grade 1) was observed in all 3 animals at 60 min and 24 h after patch removal, but was fully reversible within 48 h. No oedema reactions or other findings were reported. Erythema and oedema mean values over 24, 48, and 72 h were 0.33 and 0, respectively. In conclusion, ethoxy(trimethyl)silane was not irritating to the skin under the conditions of the test.
Eye
An eye irritation test is available with ethoxy(trimethyl)silane (CAS 1825-62-3), which was performed in Himalayan rabbits according to OECD 405 and in compliance with GLP (LPT, 2002). Neat test substance (0.1 mL) was instilled into the eye of 3 male animals. The test substance was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The eyes were examined ophthalmoscopically with a slit lamp prior to the administration of the test material and 1, 24, 48, and 72 hours after the administration of the test material. 24 h after administration the eyes were treated additionally with fluorescein and examined. No rinsing was performed. No effects on cornea and iris were observed in any animal at any reading time point. After 1 h redness (grade 1) was observed in all 3/3 animals and was fully reversible within 48 h. After 1 h chemosis grade 1 (1/3) and grade 2 (2/3) was observed and was fully reversible within 48 h. No other findings were reported. The mean values over 24, 48, and 72 h for redness and chemosis were 0, 0.33, and 0.33, each for animal 1, 2, and 3, respectively. In conclusion, ethoxy(trimethyl)silane was not irritating to the eye under the conditions of the test.
Justification for classification or non-classification
The available data on skin and eye irritation/corrosion of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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