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EC number: 203-492-7 | CAS number: 107-46-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994/05/12 - 1996/04/11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: modified methods of CTFA Safety Testing Guidelines, published by the Cosmetic, Toiletry and Fragrancy Association on September 27, 1985, and Preclinical Safety Evaluation of Materials used in Medical Devices HIMA Report 85-1.
- Deviations:
- yes
- Remarks:
- The water contained Trihalomethane (162 μg/l) that was above the EPA recommended level of 100 μg/l.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexamethyldisiloxane
- EC Number:
- 203-492-7
- EC Name:
- Hexamethyldisiloxane
- Cas Number:
- 107-46-0
- Molecular formula:
- C6H18OSi2
- IUPAC Name:
- trimethyl[(trimethylsilyl)oxy]silane
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not stated
- Age at study initiation: ca. 3 months
- Weight at study initiation: 2.31-2.59 kg
- Housing: individual housing, in conventional design stainless steel cages
- Diet: Purina 5325 Certified High Fiber Rabbit Chow, ad libitum
- Water: ad libitum
- Acclimation period: 7 day quarantine
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70
- Humidity (%): 40-60
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- other: occluded, semi-occluded or open
- Preparation of test site:
- other: intact and abraded
- 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:
- 10 applications over 14 days
- Observation period:
- 14 days
- Number of animals:
- 3/group
- Details on study design:
- TEST SITE
- Area of exposure: the back
- Type of wrap if used: For occlusive application; a cotton gauze patch covered with a piece of SARAN plastic wrap, held in place by a cotton cloth bandage taped to their hair for 24 hours. Semi-occlusive wrap; a cotton gauze patch, held in place by a cotton cloth bandage taped to the hair for 24 hours. For unocculuded applicaiton, no wrap was used.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
SCORING SYSTEM: The skin responses were cored on a 0-4 scale, 0 representing no reaction and 4 representing a severe reaction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Occluded application
- Basis:
- other: Repeated application
- Time point:
- other: Repeated 14 day exposure
- Max. score:
- 2
- Remarks on result:
- other: Very slight to well defined erythema. See Table 1 for complete mean values.
- 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:
- Occlusive group: very slight to well defined erythema and moist exfoliation was observed in all animals in this group by the fourth day of testing and continued throughout the study (abraded sites were healed by the fourth test day). A difference between intact and abraded sites showed a persistence of exfoliation at the abraded sites (exfoliation was present days 4 through 6 at intact sites and days 4 through 10 at abraded sites).
Semi-occlusive group: no test material - related irritation was observed in these animals during the study (abraded sites were healed by the fourth test day). No differences were observed between the intact and abraded sites.
Unoccluded group: No irritation was observed in animals during the course of the study (abraded sites were healed by the fourth day). No differences were seen between the intact and abraded sites. - Other effects:
- There were no apparent test material-related effects on clinical signs, food consumption or body weight gains. The occluded wrapped animals gained less weight than the other groups. This equivocal result was possibly due to the occlusive wrappings.
Any other information on results incl. tables
Table 1: Mean Skin irritation scores at various intervals (30 minutes scoring)
Method |
Skin Response
|
Score after application number* |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
||
Occlusive |
ErythemaMax. score: 4 |
0/0 |
0/0 |
0/0 |
2/2 |
2/2 |
1.3/1.3 |
0/1 |
0.7/1.7 |
1/1.7 |
0/1 |
|
Edema Max. score: 4 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Semi-occlusive |
ErythemaMax. score: 4 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
Edema Max. score: 2 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Unoccluded |
ErythemaMax. score: 4 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
Edema Max. score: 2 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
*intact/abraded
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a test that was conducted in accordance with a suitable test guideline and in compliance with GLP, L2 did not meet the criteria for classification as a skin irritant in the EU. The study involved repeated applications over 14 days and as such exceeds the requirements of the OECD 404 skin irritation study.
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