Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-842-7 | CAS number: 2550-02-9
- 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 (OCED TG 404): 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:
- 13.02.1992 to 24.04.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occluded dressing
- 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, Halle-Kűnsebeck, GERMANY
- Age at study initiation: 5-7 months
- Weight at study initiation: Males: 2.10, 2.27 kg; Females: 2.31 kg
- Housing: 1/ stainless steel cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22.5
- Humidity (%): 50-60
- Air changes (per hr): not given
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 1992-02-25 (stated) To: 1992-02- 11 (estimated) - 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
- Concentration: neat - Duration of treatment / exposure:
- 4 h
- Observation period:
- Observed at 1, 24, 48 and 72 h, and daily until day 14. Data are reported only for days 4, 7, 10 and 14.
- Number of animals:
- 3 (2 male, 1 female)
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- % coverage: not stated
- Type of wrap if used: 3-ply patch: cellulose gauze, artificial wool coated with natural rubber, "synthetic film glue"; wrap: "acrylastic" bandage
REMOVAL OF TEST SUBSTANCE
- Washing: washed off gently
- Time after start of exposure: 4 h
SCORING SYSTEM: as given in OECD 404. Grading according to Gilman et al. 1983. - Irritation parameter:
- erythema score
- Basis:
- other: mean out of animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: in animal #1 a brownish discolouration of the treated site was observed up to 5 days post-application
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritant / corrosive response data:
- All three animals formed skin scales 6-7 days after treatment. The scales peeled off 1-2 days afterwards. See table 1 for detail.
- Other effects:
- None. The general condition of the test animals was not affected.
- Interpretation of results:
- other: Category 2 based on CLP criteria (EU criteria according to Regulation (EC) No. 1272/2008)
- Conclusions:
- In a skin irritation study conducted largely in accordance with OECD 404 and to GLP (reliability score 1) but using an occlusive dressing, found triethoxypropylsilane to be moderately irritating to the skin of rabbits. Current EC criteria would concur with the findings of this study (as conducted), although it is possible that the use of a semi-occlusive dressing might reduce the irritation observed.
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 & eschar |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
2/2/2 |
4/3/3 |
24 h |
3/3/2 |
3/2/1 |
48 h |
3/3/2 |
2/2/1 |
72 h |
3/3/2 |
2/1/1 |
Day 4 |
3/3/2 |
2/1/1 |
Day 7 |
1/1/1 |
0/1/1 |
Day 10 |
1/0/1 |
0/0/0 |
Day 14 |
0/-/0 |
0/-/0 |
Mean 24, 48, 72 h |
3/3/2 |
2.3/1.7/1 |
Mean 1, 24, 48, 72 h; 3 animals |
2.5 |
2.08 |
Reversibility* |
c |
c |
Average time for reversion |
Day 14 |
Day 10 |
* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
PII= 4.6; graded moderately irritant (Gilman et al.1983)
erythema/eschar >=2.3 in 2 of 3 animals; category 2 irritant according to EC criteria
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:
- 28.02.1992 to 21.07.1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- animal husbandry - minor excursions from recommended relative humidity
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ASTA Medica AG, Halle-Kűnsebeck, GERMANY
- Age at study initiation: Males: 8 or 12 months; Females: 6 months
- Weight at study initiation: Males: 2.47, 2.49 kg; Females: 2.33 kg
- Housing: 1/ cage. Stainless steel cage with grating floor.
- Diet: standard diet approximately 120 g/day
- Water: drinking water ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 (briefly to 22.5)
- Humidity (%): 50-70 (briefly to 74). The Guideline recommends a maximum of 70%.
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 /12
IN-LIFE DATES: From: 10 March 1992 to 20 March 1992 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL (neat) - Duration of treatment / exposure:
- Single application without washing; study terminated for last animal after 6 days.
- Observation period (in vivo):
- 1, 24, 48, 72 hours, then daily to day 4 (2 animals) or 6 (1 animal).
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing : no washing
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: pencil light - Irritation parameter:
- cornea opacity score
- Basis:
- other: mean out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable.
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean out of animal #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- other: mean out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The test material was transiently irritant, see table 1.
Scored at 24, 48 and 72 h it was clear that 2 of 3 animals did not achieve scores that would be indicative of irritation. - Other effects:
- There were no systemic effects.
- 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 in compliance with GLP (reliability score 1), triethoxypropylsilane was transiently irritating, with a Draize score of 6 out of 110, and it was therefore concluded that the test substance is not irritating to the eyes.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae - redness |
Conjunctivae- chemosis |
Conjunctivae - discharge |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score 3 |
|
60 min |
0/0/0 |
1/0/0 |
3/1/2 |
3/1/1 |
3/3/3 |
24 h |
0/0/0 |
0/0/0 |
2/1/1 |
1/0/0 |
1/0/0 |
48 h |
0/0/0 |
0/0/0 |
2/1/1 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
1/1/0 |
0/0/0 |
0/0/0 |
Average 24 h, 48 h, 72 h |
0/0/0 |
0/0/0 |
1.7/1/0.7 |
0.3/0/0 |
0.3/0/0 |
Average score (including area affected, max 110)* |
0 |
0.4 |
5.3 |
||
Reversibility** |
n/a |
c |
c |
c |
c |
Maximum time for reversion |
n/a |
24 h |
6 days*** |
48 h |
48 h |
* Scoring ocular lesions: as given in report, based on 1, 24, 48, 72 h
** Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
*** Conjunctival redness was still evident in one animal at day 4.
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 of sufficient quality for classification, labelling and for risk assessment
The key data are the only irritation data available for this substance; both studies have been assigned a reliability score of 1. However, these results are the same as those for the structurally-related trimethoxypropylsilane (CAS: 1067-25-0), which was also irritating to the skin, but not the eyes.
In a key skin irritation study conducted largely in accordance with OECD TG 404 and in compliance with GLP (ASTA Medica, 1992b) but using an occlusive dressing, found triethoxypropylsilane to be moderately irritating to the skin of rabbits. It is possible that the use of a semi-occlusive dressing might reduce the irritation observed.
In a key eye irritation study conducted according to OECD TG 405 and in compliance with GLP (ASTA Medica, 1992c), triethoxypropylsilane was only transiently irritating, with a Draize score of 6 out of 110, and it was therefore concluded that the test substance is not irritating to the eyes.
Justification for classification or non-classification
Based on the available in vivo data, triethoxypropylsilane is not classified for eye irritation under Regulation (EC) 1272/2008/EC.
Regarding skin irritation, the registered substance is classififed as 'Skin Irritant Category 2', with the hazard statement 'H315: Causes skin irritation'.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.