Registration Dossier
Registration Dossier
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EC number: 217-983-9 | CAS number: 2031-67-6
- 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 (OCED TG 404): not irritating
Eye irritation (OECD TG 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:
- 16 Sep 1991 - 17 Feb 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New Zealand hybrid albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bancel, St Rambert D'Albon, FRANCE
- Age at study initiation: "adult"
- Weight at study initiation: 2.5±0.2 kg
- Housing: 1/cage; polystyrene cage with perforated flooring
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no details given
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no details given - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h. No further observation required.
- Number of animals:
- Six males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: not stated
- Type of wrap if used: 8 layer gauze pad, covered with perforated tape on crimped gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): protocol states that excess test material should be wiped away with gauze moistened with distilled water if necessary. It is not clear if this was the case.
- Time after start of exposure: 4 h
SCORING SYSTEM: according to Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- See Table 1.
- Other effects:
- None reported.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- A skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 1), found triethoxy(methyl)silane to be transiently irritating to the skin of rabbits. The report describes the material as non irritant according to EC criteria; current EC criteria would concur with this finding.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
1/0/1/1/1/1 |
0/0/0/0/0/0 |
24 h |
0/0/0/1/1/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.1 |
0 |
Reversibility* |
c |
- |
time for reversion |
48 h |
- |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- It was not compliant with GLP and lacked a detailed description of materials and methods used.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; limited details on housing, test animals and test substance identity reported
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet : Commerical diet was available ad libitum
- Water : Municipal water was available ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (neat) - Duration of treatment / exposure:
- Single exposure, without washing. Potential duration of study 14 days - appears to have been terminated at 3 days, probably because no irritation was observed by this time point.
- Observation period (in vivo):
- Examined: 1, 6, 24, 48 and 72 h.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : no washing reported
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein stain, no other details given - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Minor transient eye irritation. See table 1.
- Other effects:
- None reported.
- 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 that predates international guidelines and GLP (reliability score 2), only minor, transient eye irritation was observed following instillation of triethoxy(methyl)silane into the eyes of six rabbits. The Draize score of 0.06 (out of 13) would indicate that the test material would not be considered irritating to the eyes of rabbits.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
1/1/0/0/0/0 |
1/1/1/1/1/1 |
1/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/0/0/0/0/0 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.06 |
0 |
Reversibility*) |
n/a |
c |
c |
c |
Average time for reversion |
n/a |
24 h |
48 h |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Discharge was reported in 2/6 at the 1- and 6-h observations.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Studies were chosen as key when the available study was of relevance and sufficient quality for classification, labelling and risk assessment. Other available data are included as supporting studies.
A key skin irritation study, conducted in compliance with GLP and according to OECD TG 404, found triethoxy(methyl)silane to be a transient, mild irritant in rabbits. However, the results obtained in this study were not sufficient for classification of the registered substance as a skin irritant (Hazelton, 1992b). A limited report on skin irritation was also available, which was not conducted according to guideline or in compliance with GLP (reliability score 4) for the registered substance. The application of the undiluted test material on rabbit skin did not result in any irritation (BRRC, 1981d). The results of both experiments are in agreement with the lack of skin irritation potential of triethoxy(methyl)silane.
The key study for eye irritation which was not in compliance with GLP, but was equivalent or similar to OECD TG 405, showed that triethoxy(methyl)silane was not irritating to rabbit eyes. Only minor, transient eye irritation was observed following instillation of the test material into the eyes of six rabbits. The Draize score of 0.06 out of 13 indicates the registered substance would not be considered irritating to the eyes of rabbits ( Bushy Run Research Center, 1981).
Justification for classification or non-classification
The available data on skin and eye irritation of the registered 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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