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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 231-701-1 | CAS number: 7691-02-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.04.2007 to 08.10.2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No test substance purity details.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine
- EC Number:
- 231-701-1
- EC Name:
- N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine
- Cas Number:
- 7691-02-3
- Molecular formula:
- C8H19NSi2
- IUPAC Name:
- bis(ethenyldimethylsilyl)amine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: At least 10 weeks old
- Weight at study initiation: 2.07-2.19 kg
- Housing: Suspended stainless steel
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 5
- Humidity (%): 30-70
- Air changes (per hr): Minimum 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 04.10.2007 To: 08.10.20007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- Four hours
- Observation period:
- 72 hours (at 1, 24, 48 an 72 hours)
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: Trunk
- % coverage: Not less than 10%
- Type of wrap if used: Covered with a gauze patch, which was held in place with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residual test substance was removed by washing with sterile water.
- Time after start of exposure: Four hours
SCORING SYSTEM: Equivalent to Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak 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:
- 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:
- 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:
- 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 #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- At the 1-hour time interval two animals had Grade 1 erythema. In one of these animals the Grade 1 erythema continued to 48 hours but was completely resolved by 72 hours. In the other the erythema had resolved by 24 hours. There were no signs of irritation in the third animal.
- Other effects:
- There were no overt signs of toxicity, and all animals gained weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the skin irritation study conducted according to OECD Test guideline 404 and in compliance with GLP, N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine was concluded to be not irritating to the skin of rabbits.
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.
