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EC number: 221-339-2 | CAS number: 3069-42-9
- 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:
- 28 Sep - 01 Oct 2000
- 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:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- 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 adults
- Weight at study initiation: 2750 – 2981 g
- Housing: animals were caged in individually suspended wire-mesh cages
- Diet: PMI Nutrition International, Inc. certified rabbit LabDiet 5322, approximately 150 g per day during the study
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 – 20.0
- Humidity (%): 50 - 59
- 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(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
Reading time points: 30 - 60 min, 24, 48 and 72 h - Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm² of clipped skin of the back and flanks
- Type of wrap if used: a piece of two-ply gauze patch was placed over the treatment area and secured in place with Micropore tape. The patches were overwrapped with a gauze binder and secured with Dermiform tape. Plastic restraint collars were applied to the animals to prevent ingestion of the test article and/or bandages.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with disposable paper towels moistened with deionized water.
- Time after start of exposure: 4 h
SCORING SYSTEM
- Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- 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
- 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 mortalities occurred during the study period. The test article induced very slight erythema (grade 1) on one animal 30 – 60 min post-application. There was no edema, nor were there any other dermal findings. Based on the results of the study the test item should be considered as non-irritant.
- Other effects:
- There were no remarkable body weight changes during the study period.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- Treatment of 3 New Zealand White rabbits under semi-occlusive conditions with 0.5 ml undiluted test substance induced very slight erythema (grade 1) on one animal 30 – 60 min post-application but being fully reversible within 24 h. There was no edema, nor were there any other dermal findings. Based on the results of the study the test item should be considered as non-irritant.
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:
- 17 Nov - 24 Nov 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- No data for analytical purity is reported.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, Germany
- Age at study initiation: 6 months
- Weight at study initiation: 2400 – 2700 g
- Housing: animals were caged individually in stainless-steel cages
- Diet: maintenance diet for rabbits (ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 45 - 60
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral 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):
- 7 days
Reading time points: 1, 24, 48 and 72 h and daily up to 7 days - Number of animals or in vitro replicates:
- 2 males and 1 female
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Cliptrix fluorescent marker - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- One hour post exposure, effects on conjunctivae redness (grade 3, 3/3 animals) were observed. Mean values over 24, 48 and 72 h for conjunctivae redness were 1.33, 1.67 and 1, respectively. Any effects observed were fully reversed at the end of the observation period.
- 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 performed according to OECD 405 the substance was found to be not irritating to eyes. Treatment of 3 White Russian rabbits with 0.1 ml test substance resulted in no effects on cornea and iris in any animal at any time point. No chemosis was observed in any animal. One hour post exposure, effects on conjunctivae redness (grade 3, 3/3 animals) were observed. Mean values over 24, 48 and 72 h for conjunctivae redness were 1.33, 1.67 and 1, respectively. Any effects observed were fully reversed at the end of the observation period. Based on the results of the study the test item is considered as non-irritant.
Reference
Table 1: Summary of eye irritation parameters
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
3 |
0 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
|
48 |
2 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
1.33 |
0 |
0 |
0 |
|
2
|
1 |
3 |
0 |
0 |
0 |
24 |
2 |
0 |
0 |
0 |
|
48 |
2 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1.67 |
0 |
0 |
0 |
|
3
|
1 |
3 |
0 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1 |
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
Two skin irritation studies with Trimethoxyoctadecylsilane (CAS 3069-42-9) are available.
In a key skin irritation study performed according to OECD 404 and in compliance with GLP one female and two male 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 (WIL, 2001). Skin reactions were graded according to the Draize Scoring system 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 induced very slight erythema (grade 1) in 1/3 animals 30 – 60 min post-application, which was fully reversible within 24 h. There was no edema, nor were there any other dermal findings.
In a supporting skin irritation study performed according to OECD 404 and in compliance with GLP three female White Russian rabbits were exposed to 0.5 ml of the neat test material for 4 hours applied onto the shaved skin via occlusive dressing (Asta-Werke, 1986). Skin reactions were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. No mortalities occurred and no remarkable body weight changes were observed during the study period. Neither erythema nor edema formation were observed during the study period.
Based on the above study results the test item should be considered as not-irritating to the skin.
Eye irritation/corrosion
An eye irritation study performed according to OECD 405 and in compliance with GLP with Trimethoxyoctadecylsilane (CAS 3069-42-9) is available (Asta-Werke, 1986c). For the assessment of the eye irritation properties 0.1 ml of the test substance was instilled in the eye of one female and two male White Russian rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours and daily up to 7 days post-application. One hour post exposure, effects on conjunctivae redness (grade 3, 3/3 animals) were observed. Mean values over 24, 48 and 72 h for conjunctivae redness were 1.33, 1.67 and 1, respectively. Any effects observed had fully reversed at the end of the observation period. Neither iridial irritation nor corneal opacity and chemosis were observed in any animal during the course of the study. No remarkable body weight changes were noted during the study period. Based on the result of the study the test substance is considered not to be irritating to eyes.
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) No 1272/2008, and are therefore conclusive but not sufficient for classification.
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