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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-10 to 2002-06-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmachology and Toxicology KG, Germany
- Age at study initiation: approximately 4 months
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: kept singly in cages
- Diet: standard diet for rabbits, ssniff K-H, ad libitum
- Water: drinking water, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 55 % +/- 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:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
at 60 minutes, 24, 48 and 72 hours post-application, then every day for 14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: the area was approximately 6 cm2
- Type of wrap if used: the substance was applied to the exposure area, covered with a gauze patch and held in contact with the skin by means of semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring systhem

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:
A very slight/barely perceptible erythema was observed at 60 minutes after patch removal in all the animals. No oedema was observed in any of the test animals.
Other effects:
No other effects were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study, conducted according to OECD TG 404 and under GLP, the test material, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane , was reported to be not irritating to rabbit skin.
Executive summary:

1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was tested in a reliable study for skin irritation/corrosion. The study was conducted according to OECD TG 404, and in compliance with GLP.

0.5 mL of 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was applied undiluted onto the skin of 3 rabbits and kept in contact with the skin for 4 hours under semi-occlusive dressing. The exposure area was evaluated for skin irritation/corrosion according to Draize scoring systhem at 60 minutes, 24, 48 and 72 hours after removal of the patch.

Very slight erythema was observed at 60 minutes post-treatment in all the test animals, but fully reversible within 24 hours. No oedema was noted in any of the rabbits. The test material, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, was reported to be not irritating to rabbit skin.