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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 242-560-0 | CAS number: 18765-38-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Ten days
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetrakis(2-butoxyethyl) orthosilicate
- EC Number:
- 242-560-0
- EC Name:
- Tetrakis(2-butoxyethyl) orthosilicate
- Cas Number:
- 18765-38-3
- Molecular formula:
- C24H52O8Si
- IUPAC Name:
- tetrakis(2-butoxyethyl) orthosilicate
- Details on test material:
- - Name of test material (as cited in study report): tetrakis(2-butoxyethoxy)-silan
- Substance type: Organosilane
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2-3 kg
- Housing: No data
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
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 cm3 - Duration of treatment / exposure:
- Four hours
- Observation period:
- Ten days
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: with water after four hours
SCORING SYSTEM: According to OECD 404 (Draize)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritant / corrosive response data:
- Moderate to severe erythema and oedemawere noted up to 24 hours after patch removal. After 72 hours, in addition to moderate to severe irritation, the skin was also dry and hardened, and shed after 6-8 days. At 6 days erythema and oedema were no longer recorded. By 10 days all skin reactions had reversed.
- Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In a good quality OECD 404 study, conducted to GLP, the test material was irritating (GHS Cat.2) to the skin of three male rabbits.
- Executive summary:
Three male small White Russian rabbits were exposed to test material (0.5 cm3) under semiocclusive conditions for four hours. After four hours the test substance was washed off the skin and reactions were recorded at 30 and 60 minutes, 24, 48 and 72 hours, and 6, 8 and 10 days using the scoring system of OECD 404 (Draize). All three animals had moderate to severe erythema and oedema up to 24 hours after patch removal. After 72 hours, in addition to moderate to severe irritation, the skin was also dry and hardened, and shed after 6-8 days. At 6 days erythema and oedema were no longer recorded. By 10 days, all skin reactions had reversed. Dynasil BG ( CAS 18765-38-3) was therefore considered to be irritating (GHS Cat.2) 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.
