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EC number: 220-941-2 | CAS number: 2943-75-1
- 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
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Endpoint summary
Administrative data
Description of key information
In a skin irritation study conducted according to OECD Test Guideline 404 and in compliance with GLP (ASTA Medica AG, 1992b), triethoxy(octyl)silane was irritating to the skin of rabbits. Irritation had completely reversed by day 10. There were no systemic effects.
In an eye irritation study conducted according to OECD Test Guideline 405 and in compliance with GLP (ASTA Medica AG, 1992c), triethoxy(octyl)silane was not irritating to the eyes of rabbits. There were no systemic effects.
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:
- 22.04.1992 to 15.05.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ASTA Medica AG, D-4802 Halle-Künsebeck
- Age at study initiation: Nine months
- Weight at study initiation: Males: 2.49 and 2.52 kg; Female: 2.76 kg
- Housing: Individually in stainless steel cages
- Diet: 120 g/day/animal
- Water: Ad libitum
- Acclimation period: At least one day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 42-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27.04.1992 To: 15.05.1992 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- 9/10 days after application (at 1, 24, 48 and 72 hours, then daily)
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal area between shoulder and sacrum
- % coverage: No data, but was 6.25 cm2
- Type of wrap if used: Occlusive (patch made of the following layers: cellulose gauze, cellulose fabric coated with natural rubber, synthetic film glue; a bandage was then wrapped several times around the trunk to provide complete occlusion).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: Four hours
SCORING SYSTEM: Gilman et al (1983) Relationship between the primary dermal irritation index and ocular irritation. J. Toxicol.-Cut. & Ocular Toxicol. 2, 107-117. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours
- Score:
- 5.1
- Max. score:
- 8
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Mean scores for erythema for 24, 48 and 72 hours were at least 2.3 in all animals. The mean scores for edema for 24, 48 and 72 hours were at least 2.3 in 2/3 animals.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Table 1. Severe changes were noted in the animals. Erythema occurred in all three animals. In 2/3 animals there was moderate to severe (grade 3) erythema at one hour. At this time the erythema in the third animal was well-defined (grade 2), then at 24 hours it was moderate to severe (grade 3). These findings had completely disappeared by day 10 of the observation period. In addition, skin scales, which immediately peeled off, were observed in all three animals from day 7 onwards.
A moderate oedema (grade 3) was noted in two animals after one hour of patch removal. The edema was severe in the third animal (grade 4). These findings had reversed by day 10. - Other effects:
- Systemic effects did not occur in any animals.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In an occlusive skin irritation study conducted according to OECD 404 and in compliance with GLP (reliability score 1) triethoxyoctylsilane was irritating to the skin of rabbits. Irritation had completely reversed by day 10. There were no systemic effects.
Reference
Table 1 Summary of skin irritation scores
Skin reaction | Hours/days after exposure | Animal 1 scores | Animal 2 scores | Animal 3 scores |
Erythema and eschar | 1 hr | 2 | 3 | 3 |
24 hr | 3 | 3 | 3 | |
48 hr | 3 | 2 | 2 | |
72 hr | 3 | 2 | 2 | |
4 d | 3 | 2 | 2 | |
7 d | 2 | 2 | 3 | |
9 d | 1 | 0 | 1 | |
10 d | 0 | 0 | ||
Edema | 1 hr | 3 | 3 | 4 |
24 hr | 3 | 3 | 3 | |
48 hr | 2 | 2 | 2 | |
72 hr | 2 | 2 | 1 | |
4 d | 2 | 2 | 1 | |
7 d | 1 | 2 | 2 | |
9 d | 0 | 0 | 1 | |
10 d | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 05.05.1992 to 21.05.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: white russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ASTA Medica AG, D-4802 Halle-Künsebeck
- Age at study initiation: 8-10 months
- Weight at study initiation: Males: 2.58 kg; Females: 2.39 and 2.58 kg
- Housing: Individually in stainless steel cages
- Diet: Approx. 120 g/day/animal
- Water: Ad libitum
- Acclimation period: At least one day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20.0
- Humidity (%): 50-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11.05.1992 To: 21.05.1992 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- No rinsing
- Observation period (in vivo):
- Three days (including 1, 24, 48, 72 hours)
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Cliptrix pencil light - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: The eye irritation did not meet EU classification criteria.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Table 1. There were no changes to the cornea or iris. The conjunctiva of all three animals reacted with diffuse redness (grade 2). The finding had completely disappeared 48 hours after application. Slight swelling (grade 1) occurred in all three animals only one hour after application. In addition, discharge moistened lids and hair just adjacent to lids in one animal was observed one hour after application.
- Other effects:
- There were no systemic toxic effects in any of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1) triethoxy(octyl)silane was not irritating to the eyes of rabbits. There were no systemic effects.
Reference
Table 1 Summary of irritation scores
Reaction | Day/hours after exposure | Scores for each animal | ||
Animal 1 | Animal 2 | Animal 3 | ||
Corneal opacity | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Area of cornea involved | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Iris | 1 h | 0 | 0 | 0 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Conjunctival redness | 1 h | 2 | 2 | 2 |
24 h | 1 | 1 | 1 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Conjunctival Chemosis | 1 h | 1 | 1 | 1 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | |
Discharge | 1 h | 0 | 0 | 2 |
24 h | 0 | 0 | 0 | |
48 h | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are two skin irritation studies with a reliability score of 1, both conducted in 1992. The key study was selected because it had a longer post-exposure period and demonstrated reversibility of the irritation, and therefore more closely met the current guideline. The second reliability score 1 study also showed the test substance to be irritating to the skin of rabbits, based on the presence of desquamation at the end of the observation period.
There are also two eye irritation studies with a reliability score of 1, both conducted in 1992. The key study was selected as it had a longer observation period. However, all three available studies showed that the test substance is not irritating to the eyes .
Justification for classification or non-classification
Based on the key data, triethoxy(octyl)silane is not classified for eye irritation according to Regulation (EC) No 1272/2008. Regarding skin irritation, this substance is classified as Skin Irrit. Cat. 2 with the hazard statement 'H315: Causes skin irritation'.
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