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EC number: 299-135-8 | CAS number: 93857-00-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Pretest: 05.08.1996 to 08.08.1996. Main test: 07.10.1996 to 06.11.1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Trimethoxypropylsilane
- EC Number:
- 213-926-7
- EC Name:
- Trimethoxypropylsilane
- Cas Number:
- 1067-25-0
- IUPAC Name:
- trimethoxy(propyl)silane
- Details on test material:
- - Name of test material (as cited in study report): DYNASYLAN PTMO
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: at least one year
- Storage condition of test material: inert atmosphere
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, GERMANY
- Age at study initiation: young adults
- Weight at study initiation: <500 g
- Housing: Makrolon Type IV, max 5/cage
- Diet : Ad libitum
- Water : Ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 : 12
IN-LIFE DATES: Pretest: 05.08.1996 to 08.08.1996. Main test: 07.10.1996 to 06.11.1996
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction applications: neat
Challenge: 25%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction applications: neat
Challenge: 25%
- No. of animals per dose:
- 20 (test group); 10 (control)
- Details on study design:
- RANGE FINDING TESTS: conducted with groups of 3 animals.
Applications (6h occluded contact) of 5, 25, 50 and 100% TS with examination at 24 and 48 h following patch removal. 100% was identified as a suitable induction concentration (causing mild irritation), while 25% was identified as the lowest non-irritant challenge concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 dermal occlusive
- Exposure period: 6h
- Test groups: 20
- Control group: 10
- Frequency of applications: application on days 0, 7, 14
- Concentrations: TS neat or vehicle (corn oil) applied to the test and control groups, respectively (0.3 cc applied to a 2x2 cm patch)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: day 28
- Exposure period: 6h
- Test groups: 20
- Control group: 10
- Site: flank
- Concentrations: 25% TS in corn oil and neat corn oil applied to both the test and control groups.
- Evaluation (hr after challenge): 24 and 48 h following patch removal
- Challenge controls:
- 25% TS in corn oil and neat corn oil applied to both the test and control groups.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazol
Study design: in vivo (LLNA)
- Statistics:
- Not required.
Results and discussion
- Positive control results:
- Response rate of 30% (3/10 animals) indicates that the standard allergen is a sensitizer in the guinea pig under the conditions of this study. (See table 1.)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% TS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% TS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
GROUP |
MATERIAL |
INTERVAL (AFTER 6h CHALLENGE) |
SKIN REACTIONS (NUMBER OF ANIMALS) |
NUMBER OF ANIMALS |
SENSITIZATION INCIDENCE INDEX** |
Test |
TS (25%) |
24h |
0 |
20 |
0/20=0% |
48h |
0 |
20 |
|||
Vehicle |
24h |
0 |
20 |
0/20=0% |
|
48h |
0 |
20 |
|||
Positive control (2-mercaptobenzothiazol) |
50% MCBT in vehicle |
24h |
3 |
10 |
3/10=30%* |
48h |
0 |
10 |
|||
Vehicle (Vaseline) |
24h |
0 |
5 |
0/5=0% |
|
48h |
0 |
5 |
|||
Negative (vehicle) control |
TS (25%) |
24h |
0 |
10 |
n/a |
48h |
0 |
10 |
|||
Vehicle |
24h |
0 |
10 |
n/a |
|
48h |
0 |
10 |
* The response of 30% in the positive controls confirms that the standard allergen tested is sensitizing in guinea pig under the conditions of this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea pig skin sensitisation study (Buehler test), conducted according to OECD 406 and to GLP (reliability score 1) trimethoxypropylsilane was not a skin sensitiser.
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