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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
Reversibility:
fully reversible within:
Remarks:
24 hours
Remarks on result:
other:
Remarks:
Grade 1 erythema was noted at the 60 minute observation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
24 hours
Remarks on result:
other:
Remarks:
Grade 1 erythema was noted at the 60 minute observation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
24 hours
Remarks on result:
other:
Remarks:
Grade 1 erythema was noted at the 60 minute observation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
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 skin irritation/corrosion study 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 system 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 was fully reversible within 24 hours. No oedema was noted in any of the rabbits. The test material was reported to be not irritating to rabbit skin.