Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 220-099-6 | CAS number: 2627-95-4
Endpoint summary
Administrative data
Description of key information
The key skin irritation study, conducted according to a scientifically acceptable protocol and in compliance with GLP, found the registered substance to be not irritating to the skin of rabbits (Toxikon, 2000).
There are no eye irritation studies available for the registered substance, 1,1,3,3-tetramethyl-1,3-divinylsiloxane. Therefore, the key eye irritation study was read across from the structural analogue, hexamethyldisiloxane (HMDS; CAS 107-46-0). No irritant effects were seen in rabbit eye in response to undiluted test material. The study was reliable and conducted according to a scientifically acceptable protocol but prior to GLP implementation ( Stauffer Chemical Company, 1973).
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:
- 15/02/2000 - 17/02/2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The observation time was 48 hours instead of the recommended 72.
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Food and Drug Administration regulations, 40 CFR, Part 792
- Principles of method if other than guideline:
- Current OECD TG 404 would necessitate readings up to 72 hours after the application of the test material. In the current study observations were made only up to 48 hours.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Milbrook Breeding Labs, Amherst, MA
- Age at study initiation: at least 10 weeks old
- Weight at study initiation: 2.03 - 2.1 kg
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 15
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Single application for 3 minutes, 60 minutes and 4 hours.
- Observation period:
- Observations for visible necrosis were made at 30 - 60 minutes and again at 48 hours after bandage removal.
- Number of animals:
- 3M, 3F
- Details on study design:
- TEST SITE
- Area of exposure: The trunk of the animal, three application sites.
- % coverage: Not less than 10%.
- Type of wrap if used: 'impervious bandaging'
REMOVAL OF TEST SUBSTANCE
- Washing (if done): USP Sterile water for injection.
- Time after start of exposure: After initial reading.
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3 minutes, 30-60 minutes and 48 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- 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:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- 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
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Since there was no significant irritation at three minutes and one hour, the test substance was applied for a period of 4 hours. No erythema or oedema was noted in any of the test sites for the duration of the study. No corrosive effect was noted.
- Other effects:
- No overt signs of toxicity were evident in any of the animals during the course of the study. All of the animals exhibited a gain in body weight during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not irritating in a study conducted according to current guideline and in compliance with GLP.
Reference
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:
- 1973
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: CFR 191.12 Ch Title 21
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.6-2.1 kg
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Duration of treatment / exposure:
- Single instillation, not rinsed.
- Observation period (in vivo):
- Eyes were observed at 24, 48 and 72 hours and scored for irritation.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Eye irritation was determined according to the method outlined in the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" (Total possible score 110). If at the end of 72 hours ocular damage appears to be remissable (reversible), the animal is observed for additional 4-7 days before final scoring is possible.
- Irritation parameter:
- other: Ocular irritation.
- Basis:
- other: not specified
- Time point:
- other: 24/48/72h
- Score:
- 0
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 5
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other:
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- 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
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual animal results were not given. According to the study report no apparent signs of eye irritation were observed.
- Irritant / corrosive response data:
- No signs of eye irritation were observed.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not irritating as determined in a reliable study conducted according to generally accepted scientific principles.
Reference
No apparent signs of eye irritation were observed. The test animals
appeared normal when necropsied 14 days after treatment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key skin irritation study found no irritant effects to the skin of rabbits (Toxikon, 2000). The study was conducted according to an appropriate guideline and in compliance with GLP. The animals were exposed to the test material for 4 hours, however observations were conducted only up until 48 hours post administration contrary to the recommended minimum of 72 hours by the current OECD Test Guideline 404. No erythema or oedema was noted in any of the test sites for the duration of the study, and no corrosive effects were present.
There are no eye irritation studies available for the registered substance, 1,1,3,3-tetramethyl-1,3-divinylsiloxane. Therefore, the key eye irritation study was read across from the structural analogue, hexamethyldisiloxane (HMDS; CAS 107-46-0). The study was reliable and conducted according to a scientifically acceptable protocol but prior to GLP implementation. No apparent signs of eye irritation were observed. The test animals appeared normal when necropsied 14 days after treatment (Stauffer Chemical Company, 1973).
Justification for classification or non-classification
Based on the available information, no classification for skin and eye irritation is required for the registered substance 1,1,3,3-tetramethyl-1,3-divinylsiloxane 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
