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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 425-050-4 | CAS number: 10217-34-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-09-21 to 1996-03-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed under GLP and the study was conducted in general compliance with the US EPA OPP (Section 81-5) and TSCA Health Effects Test Guidelines, 40 CFR 798.4470
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guidelines for Registering Pesticides in the U.S.(Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Section 81-5)
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA Health Effects Test Guidelines, 40 CFR 798.4470
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Agricultural Chemicals Laws and Regulations Testing Guidelines for Toxicology Studies published by the Society of Agricultural Chemical Industry, under the auspices of MAFF
- GLP compliance:
- yes
Test material
- Reference substance name:
- Y-4036
- IUPAC Name:
- Y-4036
- Reference substance name:
- beta-(3,4 epoxycyclohexyl)ethyltriethoxysilane
- IUPAC Name:
- beta-(3,4 epoxycyclohexyl)ethyltriethoxysilane
- Details on test material:
- - Name of test material (as cited in study report): Y-4036
- Physical state: clear, colourless liquid
- Analytical purity: 98.3 %
- Purity test date: 1995-09-27
- Lot/batch No.: 16912-29
- Storage condition of test material: original container at room temperature, under these conditions the substance is stable for several years
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 2339 to 2705 grams
- 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 (e.g. ad libitum): Purina® Certified Rabbit Chow® #5322 ad libitum
- Water (e.g. ad libitum): municipal water ad libitum
- Acclimation period: a minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67.7 - 68.1 °F)
- Humidity (%): 35.6 - 56.1%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- none
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site - Duration of treatment / exposure:
- 4 h
- Observation period:
- Mortality: The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study
Dermal Observation: The application sites were observed for erythema, edema and other dermal findings approximately 30 - 60 minutes and 24, 48, and 72 hours after patch removal and on day 4 if irritation persisted. - Number of animals:
- 6, two males and four females
- Details on study design:
- TEST SITE
- Area of exposure: approximately 1" x 1"
- % coverage: no data
- Type of wrap if used: a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform® tape. Plastic restraint collars were applied and remained on the animals for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: at the end of 4 hours
SCORING SYSTEM:
Dermal irritation was graded in accordance with the method of Draize:
Evaluation of Dermal Reactions
Value
Erythema and Eschar Formation
0 No erythema
1 Very slight erythema (barely perceptible, edges of area not well defined)
2 Slight erythema (pale red in color and edges definable)
3 Moderate to severe erythema (definite red in color and area well defined)
4 Severe erythema (beet or crimson red) to slight eschar formation (injuries in depth)
4 Total possible erythema score
Edema Formation
0 No edema
1 Very slight edema (barely perceptible, edges of area not well defined)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
4 Total possible erythema score
8 Total possible Primary Irritation Score
Descriptive Ratings
Mean Primary Dermal Irritation Index
Range of Values Descriptive Rating
0 Nonirritating
0.1 - 2.0 Slightly Irritating
2.1 - 5.0 Moderately Irritating
5.1 - 8.0 Severely Irritating
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 72
- Score:
- 1
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- other: 96h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- female
- Time point:
- other: 72h
- Score:
- 0
- Other effects:
- One female had a body weight loss of 129 grams (5%) from day 0 to day 3. A body weight loss of this magnitude is common in animals which have been bandaged and collared for four hours, and was not attributed to test material.
There were no other remarkable body weight changes during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- Very slight erythema was observed on a single male animal at 72 hours post-dose. There was no edema or other dermal findings. The irritation was reversible and completely subsided by day 4.
The primary Irritation Index was calculated to be 0.0. The test material, Y-4036, received a descriptive rating classification of nonirritating. - Executive summary:
The primary dermal irritation potential of Y-4036 was evaluated in this study with New Zealand White rabbits.
Single 0.5 -ml doses of the test material were applied to the clipped, intact skin of six albino rabbits under semi-occlusive dressings for a four-hour exposure period. At completion of exposure, the bandages were removed and the sites washed. Application sites were evaluated in accordance with the method of Draize at approximately 30 -60 minutes and 24, 48 and 72 hours after patch removal and on day 4 if irritation persisted.
Very slight erythema was observed on a single male animal at 72 hours post-dose. There was no edema or other dermal findings. The irritation was reversible and completely subsided by day 4.
The Primary Irritation Index was calculated to be 0.0. The test material, Y-4036, received a descriptive ranting classification of nonirritanting.
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.
