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EC number: 213-926-7 | CAS number: 1067-25-0
- 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
Buehler test according to OECD 406: not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Pretest: 05 - 08 Aug 1996. Main test: 07 Oct - 06 Nov 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- 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, that was performed prior to the adoption of OECD 429.
- 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: Ssniff G 4-diet for Guinea Pigs, ad libitum
- Water: drinking 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
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 100%
- Day(s)/duration:
- 3 single treatments (6 h exposure), Days 0, 7 and 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25%
- Day(s)/duration:
- single treatment (6 h exposure), Day 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pre-test: 6
Main test: 20 (test group); 10 (control) - Details on study design:
- RANGE FINDING TESTS:
Applications (6 h 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: 6 h
- Test groups: neat test substance (0.3 mL applied to a 2x2 cm patch)
- Control group: verhicle corn oil (0.3 mL applied to a 2x2 cm patch)
- Site: left flank
- Frequency of applications: application on Days 0, 7, 14
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: Day 28
- Exposure period: 6 h
- Test groups: test substance in corn oil and corn oil only
- Control group: test substance in corn oil and corn oil only
- Site: posterior right flank (test substance) and anteriour right flank (vehicle)
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 h following patch removal - Challenge controls:
- The control group is actually a control.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazol (MCBT)
- 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.)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% test item
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% MCBT
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In a guinea pig skin sensitisation study (Buehler test), conducted according to OECD 406 and to GLP (reliability score 1) trimethoxy(propyl)silane was not a skin sensitiser.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the available key study (Hüls AG, 1997) the test item trimethoxy(propyl)silane (CAS 1067-25-0) was tested for skin sensitising properties according to OECD 406 (Buehler test) and in compliance with GLP. Corn oil was used as the vehicle / negative control. The test species was the Dunkin-Hartley Guinea pig (20 and 10 animals in the test and control groups, respectively). During the induction phase the test item was applied at 100% for 6 h on Days 0, 7 and 14. During the challenge phase (Day 28), the test item was applied at 25% in corn oil for 6 h. Evaluation of the dermal responses were made at 24 and 48 h following patch removal. The sensitisation rate after application of the test item was 0%. The positive control substance 2-mercaptobenzothiazol showed the expected sensitization response demonstrating the test system functioned correctly. Under the test conditions described, the test item showed no sensitising effects.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on sensitisation 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.
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.
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