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EC number: 425-050-4 | CAS number: 10217-34-2
- 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:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate test method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 425-050-4
- EC Name:
- -
- Cas Number:
- 10217-34-2
- Molecular formula:
- C14H28O4Si
- IUPAC Name:
- triethoxy(2-{7-oxabicyclo[4.1.0]heptan-3-yl}ethyl)silane
- Details on test material:
- Test article ID (as cited in the study): Y-11870 is beta-(3,4-epoxycyclohexyl)ethyltriethoxysilane
Molecular formula: C13H26O4Si
Molecular weight: 274,43
Physical state: Clear, colorless liquid
Analytical purity: 92.7%
Lot/batch no: 113191
Source: CKWitco Corporation, Organosilicones Group, 3500 South State Route 2, Friendly, WV 26146
Test article receipt: 2000-06-19 (expiration date was not provided)
Stability under test conditions: Stable
Storage condition of test material: At room temperature; once opened, the test article was blanketed under nitrogen prior to being resealed
Certificate of analysis: see appendix IV (FTIR, GC/MS)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: young adult
- Weight at study initiation: 292 to 335 grams (males) and 290 to 332 grams (females)
- Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc. in accordance with standard operating procedures
- Diet: PMI Nutrition International, Inc Certified Guinea Pig LabDiet 5026 (analysis of feed was performed and provided by manufactureer)
- Water: municipal water were provided ad libitum (water was analyzed in accordance with standard operating procedures).
- Acclimation period: The animals used on the main study were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.
ENVIRONMENTAL CONDITIONS
- Temperature: 68 to 74 °F
- Humidity (%): 30 to 62 %
- Photoperiod (12 hrs dark / 12 hrs light):
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 2.5%, 5%, 10%, 25%, 50%, 100% (primary irritation)
100% (induction)
100% (challenge)
50% (challenge; positive control)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 2.5%, 5%, 10%, 25%, 50%, 100% (primary irritation)
100% (induction)
100% (challenge)
50% (challenge; positive control)
- No. of animals per dose:
- test group: 10/sex
positive control: 5/sex
naive control: 5/sex - Details on study design:
- Range finding test:
2.5, 5%, 10%, 25%, 50%, 100% (vehicle ethanol), 4/concentration
RANGE FINDING TESTS:
2.5, 5, 10, 25, 50, 100% (vehicle ethanol), 4/concentration
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 10 males, 10 females
- Control group: 5 males, 5 females (positive control); 5 males, 5 females (naive control)
- Frequency of applications: 7 days between application
- Concentrations: Test group 100% test substance; naive control untreated; positive control 100% hexylcinnamaldehyde HCH
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: challenge exposure 14 days following last induction
- Exposure period: 6 h
- Test groups: as above
- Control group: as above
- Concentrations: Test group 100% test substance; naive group 100% test substance; positive control 50% HCA in acetone
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- control group: 5/sex
- Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamaldehyde (HCA)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- moderate to slight dermal reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: moderate to slight dermal reaction.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- slight dermal reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: slight dermal reaction.
Any other information on results incl. tables
Dermal Scores* | |||||||||
Group | Material | Interval | 0 | +/- | 1 | 2 | 3 | Sensitization Incidence Index | Severity Index |
test | 100% TS | 24 hours | 0/20 | 8/20 | 11/20 | 1/20 | 0/20 | 70% | 0.9 |
48 hours | 0/20 | 6/20 | 14/20 | 0/20 | 0/20 | 0.9 | |||
naive control | TS | 24 hours | 1/10 | 9/10 | 0/10 | 0/10 | 0/10 | not applicable | 0.5 |
48 hours | 4/10 | 6/10 | 0/10 | 0/10 | 0/10 | 0.3 | |||
positive control | HCA | 24 hours | 0/10 | 0/10 | 8/10 | 2/10 | 0/10 | 100% | 1.2 |
48 hours | 0/10 | 0/10 | 9/10 | 1/10 | 0/10 | 1.1 |
*Skin reactions were graded:
0 no reaction
+/- slightly patchy erythema (equates to a score of 0.5)
1 slight confluent or moderately patch erythema
2 moderate erythema
3 severe erythema with or without edema
** Sensitization incidence index is the number of animals having post-challenge sensitization responses at either 24 or 48 hours divided by the number of animals in the group.
*** Severity Index: The Severity Index is the sum of the post-challenge test grades divided by the total number of animals tested (rounded to the nearest tenth). This index was calculated for each group separately at 24 and 48 hours. Grades of +/- were equal to 0.5 for calculation purposes.
There were no clinical findings noted during the study. There were no remarkable body weight changes observed during the study.
For the native control group, the test article produced nine very slight dermal reactions at the 24 hour observation and six very slight dermal reactions at the 48 hour observation. Reactions for the positive control group guinea pigs after challenge dosing included two moderate and eight slight dermal reactions at 24 hours post exposure. By 48 hours, dermal irritation included one moderate and nine slight reactions.
The test article produced one moderate (grade 2), 11 slight (grade 1) and eight very slight (grade +/-) dermal reactions for the test group guinea pigs at the 24 hours observation. At the 48 hour observation, 14 slight and six very slight dermal reactions were noted.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guinea pig sensitization test (Buehler method; non-adjuvant) reported that a 100% concentration of the test substance induced a sensitization response (in 70%) when challenged with a 100 % solution. Appropriate naive and positive complicance control were included.
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