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EC number: 219-154-7 | CAS number: 2374-14-3
- 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
Endpoint summary
Administrative data
Description of key information
In the key skin irritation study for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the registered substance was concluded to be not irritating to rabbit skin (BSL Bioservice, 2013a).
In the key eye irritation study for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane, conducted according to OECD Test Guideline 405 and in compliance with GLP, the registered substance was concluded to be not irritating to eyes (BSL Bioservice, 2013b).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-21 to 2012-10-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: 21-22 weeks old
- Weight at study initiation: >2kg
- Housing: plastic rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: left side on the dorsal area
- Type of wrap if used: the test item was applied to a gauze patch, which was applied to the skin and held in place with non-irritating tape. The patch was fixed with semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Initial test in animal no. 1: no signs of irritation were seen immediately after the patch removal. Examination of the test site 1 hour after patch removal revealed erythema grade 1 which was fully reversible within 24 hours after the patch removal. No irritant or corrosive effects were observed on the intact skin of the two further female rabbits (strain NZW) of the main test after a contact time of 4 hours.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritant effects to rabbit skin were observed in a study conducted according to current OECD guideline and under GLP.
Reference
Under the conditions of the present study, the single dermal application of the test item F-D3 to three rabbits at a dose of 0.5 g showed irritant but no corrosive effects in animal no.1 which were fully reversible within 24 hours. Neither mortalities nor significant clinical signs of toxicity were observed.
Table: Dermal Irritation Evaluation
Animal |
Application |
Irritation (hours after patch removal) |
|||||||
1 hour |
24 hours |
48 hours |
72 hours |
||||||
T |
C |
T |
C |
T |
C |
T |
C |
||
1 |
Erythema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
T = test item; C = control; 0 – 3 = grade
Table: Individual Data
Individual Systemic and Local Findings - Animal No. 1 |
|||
Time after |
Systemic Findings |
Specific Local Findings (apart from erythema/oedema) |
Comments |
1 hour |
nsf |
nsf |
- |
24 hours |
nsf |
nsf |
- |
48 hours |
nsf |
nsf |
- |
72 hours |
nsf |
nsf |
- |
Individual Systemic and Local Findings - Animal No. 2 |
|||
Time after |
Systemic Findings |
Specific Local Findings (apart from erythema/oedema) |
Comments |
1 hour |
nsf |
nsf |
- |
24 hours |
nsf |
nsf |
- |
48 hours |
nsf |
nsf |
- |
72 hours |
nsf |
nsf |
- |
Individual Systemic and Local Findings - Animal No. 3 |
|||
Time after |
Systemic Findings |
Specific Local Findings (apart from erythema/oedema) |
Comments |
1 hour |
nsf |
nsf |
- |
24 hours |
nsf |
nsf |
- |
48 hours |
nsf |
nsf |
- |
72 hours |
nsf |
nsf |
- |
nsf = no specific findings
Table: Absolute Body Weights in kg
|
Animal No. 1 |
Animal No. 2 |
Animal No. 3 |
Start of Study |
4.4 |
4.2 |
3.1 |
End of Study |
4.4 |
4.2 |
3.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-10-29 to 2012-11-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: ca. 14 weeks old
- Weight at study initiation: >2kg
- Housing: plastic rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
The test item was gently warmed in a water bath at 32 °C for liquid application. - Duration of treatment / exposure:
- single instillation,
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The treated eye was not rinsed 24 hours after the application.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- After the application into the eyes of three female NZW rabbits the test item produced slightly irritant but no corrosive effects.
Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.
Conjunctival redness and discharge were observed in all animals. - Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritant effects to rabbit eyes were observed in a study conducted according to current OECD guideline and under GLP.
Reference
Table: Eye Irritation Scores – Animal No. 1
Animal No. 1 |
Single Data |
|||||
|
Time Post-Application |
Average Score |
||||
1 hour |
24 hours |
48 hours |
72 hours |
|||
T/C |
T/C |
T/C |
T/C |
|||
Conjunctival Redness |
1/0 |
1/0 |
1/0 |
0/0 |
0.67 |
|
Conjunctival Chemosis |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
T =test item, C = control
Table: Eye Irritation Scores – Animal No. 2
Animal No. 2 |
Single Data |
|||||
|
Time Post-Application |
Average Score |
||||
1 hour |
24 hours |
48 hours |
72 hours |
|||
T/C |
T/C |
T/C |
T/C |
|||
Conjunctival Redness |
1/0 |
1/0 |
1/0 |
0/0 |
0.67 |
|
Conjunctival Chemosis |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
T =test item, C = control
Table: Eye Irritation Scores – Animal No. 3
Animal No. 3 |
Single Data |
|||||
|
Time Post-Application |
Average Score (24, 48 and 72 hours) |
||||
1 hour |
24 hours |
48 hours |
72 hours |
|||
T/C |
T/C |
T/C |
T/C |
|||
Conjunctival Redness |
1/0 |
1/0 |
1/0 |
0/0 |
0.67 |
|
Conjunctival Chemosis |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Iris |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
|
Cornea |
0/0 |
0/0 |
0/0 |
0/0 |
0 |
T =test item, C = control
Table: Clinical Signs of Toxicity
Animal No. 1 |
Time after |
Systemic Findings |
Local Findings |
1 hour |
nsf |
discharge grade 1 |
|
24 hours |
nsf |
nsf |
|
48 hours |
nsf |
nsf |
|
72 hours |
nsf |
nsf |
|
Animal No. 2 |
Time after |
Systemic Findings |
Local Findings |
1 hour |
nsf |
discharge grade 2 |
|
24 hours |
nsf |
discharge grade 1 |
|
48 hours |
nsf |
nsf |
|
72 hours |
nsf |
nsf |
|
Animal No. 3 |
Time after |
Systemic Findings |
Local Findings |
1 hour |
nsf |
discharge grade 2 |
|
24 hours |
nsf |
nsf |
|
48 hours |
nsf |
nsf |
|
72 hours |
nsf |
nsf |
nsf: no specific findings
Table: Absolute Body Weights in kg
|
Animal No. 1 |
Animal No. 2 |
Animal No. 3 |
Start of Study |
3.1 |
3.1 |
3.0 |
End of Study |
3.2 |
3.2 |
3.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the key skin irritation study for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane, conducted according to OECD Test Guideline 404 and in compliance with GLP, the registered substance was concluded to be not irritating to rabbit skin (BSL Bioservice, 2013a). Following a 4-hour semioccluded application of 0.5 ml of the undiluted test material onto the skin of 3 rabbits, mild irritant effects were present in one animal, which were fully reversible within 24 hours. Neither mortalities nor significant clinical signs of toxicity were observed.
In the key eye irritation study
for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane,
conducted according to OECD Test Guideline 405 and in compliance with
GLP, the registered substance was concluded to be not irritating to eyes
(BSL Bioservice, 2013b). Following a single ocular instillation of 0.1
ml of the undiluted test material into the eyes of 3 rabbits, no ocular
symptoms were noted.
Justification for classification or non-classification
Based on the available information, no classification for skin or eye irritation is required for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane according to Regulation (EC) No 1272/2008.
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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