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EC number: 241-881-3 | CAS number: 17955-88-3
- 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:
- 16 February 2016 to 12 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because the 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:
- 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane
- EC Number:
- 241-881-3
- EC Name:
- 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane
- Cas Number:
- 17955-88-3
- Molecular formula:
- C15H38O2Si3
- IUPAC Name:
- 2,2,4,6,6-pentamethyl-4-octyl-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0008356364; no data on source
- Expiration date of the lot/batch: 04.06.2016
- Purity test date: 02.05.2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, keep away from oxidizing agents, use with adequate ventilation, avoid moisture and repeated exposure to air
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was soluble in DMSO and Acetone. A solubility test was performed to define the maximum concentration which is technically applicable to the animals. Solubility was found for the vehicle acetone at a concentration of 75 %.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For the challenge 0.15 ml of the test item was dissolved with the vehicle to give a final volume of 20 ml. The solution was prepared directly before application.
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl: HA
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Females: not applicable
- Microbiological status of animals, when known: no data
- Age at study initiation: 4 weeks old
- Weight at study initiation: 344 - 401 g
- Housing: housed in a semi barrier in an air-conditioned room
- Diet: autoclaved hay and Altromin 3122 maintenance diet for guinea pigs, rich in crude fibre, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10 x/ hour
- Photoperiod (hrs dark / hrs light): 12/ 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone
- Concentration / amount:
- 100 %
- Day(s)/duration:
- Once a week for 6 hours for 3 weeks
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Acetone
- Concentration / amount:
- 0.75 %
- Day(s)/duration:
- single 6-hour application
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary test: 5
Test group: 20
Negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: Different concentrations of the test sample diluted with the vehicle acetone were applied topically to the flanks of 5 animals for 6 hours using occlusive dressing to determine the concentrations for the main study. The first animal was treated with 100% (undiluted), 75%, 1.5% and 0.75% of the test item in acetone; the second animal was treated with 50% and 25%; the third animal was treated with 12.5% and 6.25%; the fourth animal was treated with 6.25% and 3% and the fifth animal was treated with 1.5% and 0.75%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three topical induction exposures
- Exposure period: one a week for 6 hours for 3 weeks
- Test groups: a Hill Top Chamber loaded with 0.5 ml of the test substance
- Control group: an empty Hill Top Chamber
- Site: left flank (2.5 x 2.5 cm)
- Frequency of applications: single 6-hour application, once a week for 3 weeks
- Duration: 6 hours
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: single exposure
- Day(s) of challenge: 14 days after the last induction application
- Exposure period: 6 hours
- Test groups: a Hill Top Chamber loaded with 0.5 ml of the test substance (right flank) and a Hill Top Chamber loaded with 0.5 ml of the vehicle (left flanks)
- Control group: a Hill Top Chamber loaded with 0.5 ml of the test substance (right flank) and a Hill Top Chamber loaded with 0.5 ml of the vehicle (left flanks)
- Site: right and left flanks of both test and negative control groups
- Concentrations: 0.75 %
- Evaluation (hr after challenge): at 24 and 48 hours after removing the patch the skin reactions were evaluated
- Challenge controls:
- Intraspecific control: the left flank (untreated site) of all the animals was treated with 0.5 ml of acetone
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole, 50 % in vaseline at inductions I, II and III, and 25 % in vaseline at challenge
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (25% in vaseline) was 85%, confirming the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.75 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Neither erythema nor oedema was observed in any of the animals; no signs of toxicity were recorded; all animals survived throughout the test period
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Neither erythema nor oedema was observed in any of the animals; no signs of toxicity were recorded; all animals survived throughout the test period
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Neither erythema nor oedema was observed in any of the animals; no signs of toxicity were recorded; all animals survived throughout the test period
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Neither erythema nor oedema was observed in any of the animals; no signs of toxicity were recorded; all animals survived throughout the test period
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% mercaptobenzothiazole (in vaseline) inductions I, II and III; 25% (in vaseline) challenge.
- No. with + reactions:
- 17
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The recent reliability check was performed in Novenber/December 2015; the results are expresses as percentage of animals with reactions. The number of animals in the group was not stated but has been assumed to be 20.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50% mercaptobenzothiazole (in vaseline) inductions I, II and III; 25% (in vaseline) challenge.
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The recent reliability check was performed in Novenber/December 2015; the results are expresses as percentage of animals with reactions. The number of animals in the group was not stated but has been assumed to be 20.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitisation study, conducted according to OECD TG 406 and in compliance with GLP, reports the test substance, 1, 1, 1, 3, 5, 5, 5-heptamethyl-3-octyltrisiloxane, to be not sensitising to the skin of guinea pigs.
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