Registration Dossier
Registration Dossier
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EC number: 217-496-1 | CAS number: 1873-88-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 107-51-7
- Reference substance name:
- Octamethyltrisiloxane
- EC Number:
- 203-497-4
- EC Name:
- Octamethyltrisiloxane
- Cas Number:
- 107-51-7
- Molecular formula:
- C8H24O2Si3
- IUPAC Name:
- octamethyltrisiloxane
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages with an automatic cleaning system equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet: Provimi Kliba 3410 rabbit maintenance diet, ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: Yes, but unspecified for how long.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 72 hours.
- Number of animals:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure:dorsal
- Type of wrap if used: The area onto which the test article was applied was covered with a patch of surgical gauze, which was covered with semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to EEC Commission Directive 92/69/EEC, July 31, 1992
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:
- 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:
- No signs of irritation were observed. No corrosive effects were noted on the treated skin of any animal at any measuring interval.
- Other effects:
- The test article did not cause staining of the treated skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not irritating in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.
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