Registration Dossier
Registration Dossier
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EC number: 240-212-2 | CAS number: 16068-37-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
- EC Number:
- 240-212-2
- EC Name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
- Cas Number:
- 16068-37-4
- Molecular formula:
- C14H34O6Si2
- IUPAC Name:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology KG, Löhndorf D-24601/Post Wankendorf, GERMANY
- Age at study initiation: 4 months
- Weight at study initiation: 1.9-2.1 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 55 +/-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 2002-04-24 (estimated) To: 2002-04-28 (stated)
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: 0.5 ml
- Concentration: neat - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm2
- % coverage: not stated
- Type of wrap if used: gauze patch held under semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not necessary
SCORING SYSTEM: according to OECD 404: scored for erythema and eschar (max 4) and oedema (max 4), at 1, 24, 48 and 72 h following exposure.
Results and discussion
In vivo
Resultsopen allclose all
- 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:
- No irritant response was reported at any of the observation times of 1, 24, 48 and 72 h.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 h |
0/0/0 |
0/0/0 |
24 h |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
Reversibility* |
n/a |
n/a |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane has been tested for acute skin irritation in a semi-occlusive study conducted according to OECD TG 404 and in compliance with GLP. No irritant response was reported at any of the observation times of 1, 24, 48 and 72 h. It is concluded that the test substance is not irritating to the skin.
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