Registration Dossier
Registration Dossier
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EC number: 221-906-4 | CAS number: 3277-26-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 1,1,3,3-tetramethyldisiloxane
- EC Number:
- 221-906-4
- EC Name:
- 1,1,3,3-tetramethyldisiloxane
- Cas Number:
- 3277-26-7
- Molecular formula:
- C4H14OSi2
- IUPAC Name:
- 1,1,3,3-tetramethyldisiloxane
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
- Age at study initiation: Approximately 6-6.5 months
- Weight at study initiation: 2.4-2.7 kg
- Housing: Singly in cages measuring 425 mm x 600 mm x 380 mm
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55± 15
- 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 ml
- Duration of treatment / exposure:
- Four hours
- Observation period:
- Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions.
- Number of animals:
- Three male rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
SCORING SYSTEM: According to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: All
- Score:
- 0
- 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
- Other effects:
- No other effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, concluded that the registered substance, 1,1,3,3-tetramethyldisiloxane, is not irritating to rabbit skin.
- Executive summary:
Three Himalayan rabbits were exposed for four hours to 0.5 ml Siloxan HSi2 under semi-occlusive conditions on intact skin. The reactions of the intact skin were evaluated 60 minutes and then 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions. No skin reactions or other effects were observed at any of the time points in any of the rabbits.
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