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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
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occluded dressing
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triethoxypropylsilane
- EC Number:
- 219-842-7
- EC Name:
- Triethoxypropylsilane
- Cas Number:
- 2550-02-9
- Molecular formula:
- C9H22O3Si
- IUPAC Name:
- triethoxy(propyl)silane
Constituent 1
Test animals
- 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)
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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