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EC number: 240-464-3 | CAS number: 16415-12-6
- 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 in rabbits (OECD TG 404, GLP): not irritating
Eye irritation in rabbits (OECD TG 405, GLP): 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 Apr 2002 to 12 Aug 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 1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Löhndorf/Wankendorf, Germany
- Age at study initiation: 2-2.5 months
- Weight at study initiation: 2.3-2.5 kg
- Housing: Individually in cages
- Diet: Ad libitum
- 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: 15.04.2002 To: 30.04.2002 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72h, 4 and 5 days
- Number of animals:
- Three males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of trunk
- % coverage: No data, but area was 6 cm².
- Type of wrap if used: Gauze patch held in place with non-irritating tape (semi-occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- 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: reversibility: not applicable
- Other effects:
- No systemic effects reported.
- 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), hexadecyl(trimethoxy)silane was minimally transiently irritating to the skin of one of three rabbits. There were no systemic effects reported.
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 and eschar |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
0/0/1 |
0/0/0 |
24 h |
0/0/1 |
0/0/0 |
48 h |
0/0/1 |
0/0/0 |
72 h |
0/0/1 |
0/0/0 |
4 days |
-/-/1 |
-/-/0 |
5 days |
-/-/0 |
-/-/0 |
Average 24h, 48h, 72h |
0/0/1 |
0/0/0 |
Reversibility* |
c |
n/a |
Time for reversion |
Day 5 |
- |
* 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:
- 12.04.2002 to 30.07.2002
- 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 1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology, Löhndorf, GERMANY
- Age at study initiation: 2.5-3.5 months
- Weight at study initiation: 2.4 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2002-04-15 To: 2002-05-03 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye is the control in each case
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml - Duration of treatment / exposure:
- Single administration, not irrigated. Observed up to 72 h.
- Observation period (in vivo):
- 1, 24, 48, 72 h.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: after Draize, according to OECD 405
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- 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
- Irritant / corrosive response data:
- Conjunctival redness (grade 1) at 1 h and 24 h; conjunctival chemosis (grade 1) at 1 h. No corneal or iridial effects, or any other observations. The overall irritation score (24, 48, and 72 h) was 0.3 (max. score 13).
- Other effects:
- None.
- 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 according to OECD 405 and GLP (reliability score 1), hexadecyltrimethoxysilane was not irritating to the eyes of rabbits. There were no other effects reported.
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 |
Conjunctival redness |
Conjunctival chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
1/1/1 |
1/1/1 |
24 h |
0/0/0 |
0/0/0 |
1/1/1 |
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 |
0/0/0 |
0/0/0 |
0.3/0.3/0.3 |
0/0/0 |
Maximum average score (max 13) |
0 |
0 |
0.3 |
0 |
Reversibility* |
- |
- |
c |
c |
Average time (unit) for reversion |
- |
- |
48 h |
24 h |
* 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 the key skin irritation study conducted in accordance with OECD TG 404 and GLP (LPT, 2002b), the semi-occlusive application of hexadecyl(trimethoxy)silane for 4 h caused in one of the three rabbits very slight erythema (grade 1) from 60 min up to 4 days after patch removal. The effect was fully reversible within 5 days. The mean erythema and edema scores over 24/48/72 h out of all three animals were 0.33 and 0, respectively. There were no systemic effects reported. In conclusion, the test substance is not irritating to the skin.
Eye irritation:
In the key eye irritation study conducted according to OECD TG 405 and GLP (LPT, 2002c), hexadecyl(trimethoxy)silane was not irritating to the eyes of rabbits, after instillation of 0.1 ml of the test substance into the rabbits eye. No effects on cornea and iris were observed in any animal throughout the whole study period. Redness (grade 1) was observed in all animals at 1 h and 24 h, and was fully reversible within 48 h. Chemosis (grade 1) was observed in all animals at 1 h, but was fully reversible within 24 h. The resulting mean scores over 24/48/72 h out of all three animals were 0, 0, 0.33, and 0 for cornea, iris, redness, and chemosis, respectively. There were no other effects reported.
These findings were supported by an eye irritation study conducted in rabbits according to OECD TG 405 and GLP (Asta Pharma, 1989c). No effects on cornea and iris were observed in the 3 animals throughout the whole study period. Redness (grade 2) was observed in 2/3 animals at 1 h, reversed to grade 1 in 3/3 animals after 24 h and was fully reversible within 6 days. Chemosis (grade 1/2) was observed in the animals, but was fully reversible within 6 days. The resulting mean scores over 24/48/72 h out of all three animals were 0, 0, 0.9, and 1.1 for cornea, iris, redness, and chemosis, respectively. Conjunctival discharge (grade 3) was observed in all animals 1 h after treatment, clearly decreased within 24 h (max. grade 1 in 2/3 animals), and was fully reversible within 48 h.
In conclusion, the test substance is not irritating to the eye under the applied conditions.
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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