Registration Dossier
Registration Dossier
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EC number: 469-070-1 | CAS number: 17861-60-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 469-070-1
- EC Name:
- -
- Cas Number:
- 17861-60-8
- Molecular formula:
- C9H26O2Si3
- IUPAC Name:
- 4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane
- Test material form:
- liquid
- Details on test material:
- Other name: Baysilone TP 3886
Constituent 1
- Specific details on test material used for the study:
- Density: 828 g/L at 20°C
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test animals:
Age on arrival: 9 weeks
Acclimatisation: 5 days
Bodyweight at start of study: 1.709-2.007 kg
Housing: individually housed in stainless steel cages
Diet: standard laboratory diet ad libitum
Water: tap water ad libitum
Environmental conditions:
Temperature: 20 +/-3°C
Humidity: 30-70%
Ventilation: 10 air changes per hour
Lighting: 12 hours light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL test material was distributed on a gauze patch measuring 2.5 x 2.5 cm and fixed to the clipped flank of the animal.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Skin reactions were evaluated one hour after treatment then at 24, 48 and 72 hours after treatment
- Number of animals:
- 3 males
- Details on study design:
- The patch loaded with the test material was fixed to the application site by means of semi occlusive adhesive tape.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
Skin irritation scores
Animal no. |
Time after removal of test material (hours) |
|||
1 |
24 |
48 |
72 |
|
A-B |
||||
8 (#1) |
0-0 |
0-0 |
0-0 |
0-0 |
10 (#2) |
0-0 |
0-0 |
0-0 |
0-0 |
12 (#3) |
0-0 |
0-0 |
0-0 |
0-0 |
A = erythema (including ischemia, haemorrhages and incrustation)
B = oedema
Mean values for erythema and oedema for each rabbit scored 24, 48 and 72 h after treatment was zero.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results obtained it is concluded that heptamethylethyltrisiloxane is non-irritating to skin under conditions of this study therefore no classification is required
- Executive summary:
The primary skin irritation potential of heptamethylethyltrisiloxane was evaluated in three male New Zealand White rabbits. A dose of 0.5 mL of the test substance was placed on a gauze patch and applied to clipped intact dorsal skin of each rabbit for 4 hours. Skin reactions of erythema and oedema were scored 1, 24, 48 and 72 hours after removal of the patches. Skin irritation reactions were not observed in any animals during the observation period after the removal of patch.
Based on these results, heptamethylethyltrisiloxane is considered to be a non-irritant.
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