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EC number: 201-081-7 | CAS number: 78-08-0
- 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), rabbit: not irritating
Eye irritation (OECD 405), rabbit: 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:
- 12 May 1998 to 23 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA
- Age at study initiation: "young adult"
- Weight at study initiation: 3.09-4.31 kg
- Housing: 1 per suspended wire mesh cage
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-19.5
- Humidity (%): 39.8-61.5
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 1998-05-12 To: 1998-05-23 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: neat (100%) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 11 days
Reading time points: 30-60 min, and 24, 48 and 72 h following removal of patch. - Number of animals:
- 6 (3/sex)
- Details on study design:
- TEST SITE
- Area of exposure: backs and flanks
- Type of wrap if used: semi-occlusive: 2-ply gauze patch, overwrapped with gauze binder, secured with dermiform tape
REMOVAL OF TEST SUBSTANCE
- Washing: wiped with moist paper towel
- Time after start of exposure: 4h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: desquamation observed up to Day 11
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- All rabbits had very slight to slight erythema. Very slight edema was noted on 5/6 rabbits. Desquamation was observed in two rabbits. There were no other dermal findings. All dermal findings were reversible and completely subsided by day 11 or earlier.
- Other effects:
- No deaths occurred during the study period and no 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 conducted in accordance with OECD 404 and GLP (reliability score 1), triethoxy(vinyl)silane was concluded to be slightly irritating to the skin of rabbits. The test material would not be described as irritating if current EU criteria were applied.
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 |
2/1/1/1/1/2 |
1/1/1/0/1/1/ |
24 h |
2/1/2/1/1/1 |
1/0/1/0/0/0 |
48 h |
1/1/1/0/1/1 |
0/0/0/0/0/0 |
72 h |
1/0/1/0/1d*/1 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0.9 |
0.1 |
Reversibility: completely reversible |
erythema by day 9; desquamation by day 11 |
edema by 48 h |
* desquamation
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:
- 18 May 1998 to 25 May 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Other guidelines also mentioned.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products Inc., Denver, PA, USA
- Age at study initiation: young adults - not further specfied
- Weight at study initiation: 3.0-3.2 g (males); 3.7-4.8 g (females)
- Housing: individual suspended mesh-bottomed cages
- Diet: standard diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-19.4
- Humidity (%): 39.8-64.3
- Photoperiod: 12 h/12 h
IN-LIFE DATES: 18.05.1998 to 25.05.1998 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: n/a - neat - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 1, 24, 48 and 72 h after application - Number of animals or in vitro replicates:
- 2 males, 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: unwashed
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-held pen light at all time points; use of sodium fluorescein at 72 h. - 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:
- 0.1
- 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:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Minor (grade 1) conjunctival effects in 6/6 at 1 h, in 2/6 at 24 h and in 1/6 at 48 h, but no corneal or iridial effects were noted (see table 1). The maximum average score (MAS), for all time points 1-72 h, was given as 4 (at 1 h) (see also table 1).
- Other effects:
- There were no deaths observed during the study. One animal lost 6% of its body weight during the test. Slight losses were considered in the report to be common among this weight range and strain.
- 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 conducted in accordance with OECD 405 and to GLP (reliability score 1) triethoxy(vinyl)silane was not 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 |
|||
Opacity - Max. score 4 (a) |
Area - Max. score 4 (b) |
Max. - score 2 (c) |
Redness - Max score 3 (d) |
Chemosis - Max. score 4 (e) |
Discharge -Max. score 3 (f) |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/1/1/1/1 |
1/1/1/1/1/1 |
0/0/0/0/0/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/1/1/0/0 |
0/0/1/0/0/0 |
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 |
0/0/1/0/0/0 |
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 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0 |
0.1 |
0.1 |
0 |
Maximum total scores** for each time point (max 110), described in the report as maximum average score (MAS) |
MAS: 4 (I h); 1 (24 hr); 0.3 (48 h); 0 (72 h) [in each case the score is the average for 6 animals] |
|||||
Reversibility*** |
n/a |
n/a |
n/a |
c |
c |
n/a |
Time for reversion (h) |
- |
- |
- |
48 |
72 |
- |
*Each entry shows values for each of the 6 animals
**Maximum total score (average of 6 animals in each case) = [axbx5] + [cx5] + [(d+e+f)x2] =110
***Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a skin irritation study conducted in accordance with OECD 404 and GLP (WIL Research Labs Inc., 1998c), the test substance was concluded to be slightly irritating to the skin of rabbits. However, the observed irritation did not meet the criteria for classification under Regulation (EC) No. 1272/2008. 3 rabbits per sex were treated with 0.5 ml of the neat test substance for 4 h. The mean scores (over 24, 48, and 72 h) were 0.9 for erythema and 0.1 for oedema reactions. Desquamation was observed in 1/6 animals after 72 h and was fully reversible within 11 days. Erythema and oedema reactions were fully reversible within 9 days and 48 h, respectively.
Eye irritaion
In an eye irritation study conducted in accordance with OECD 405 and GLP (WIL Research Labs Inc., 1998d), the test substance was not irritating to the eyes of rabbits. 2 male and 4 female rabbits were treated with 0.1 ml of the neat test substance and were observed up to 72 h. No washing was performed after treatment with the test substance. Minor (grade 1) conjunctival effects were observed in 6/6 animals at 1 h, in 2/6 animals at 24 h and in 1/6 animals at 48 h, but no corneal or iridial effects were observed. The mean score over 24, 48, and 72 h was 0.1 for conjunctivae and was fully reversible within 48 h. Chemosis mean score was 0.1 with a maximum grade of 1 and was fully reversible within 72 h.
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) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
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