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Diss Factsheets

Administrative data

Description of key information

In the key skin irritation study, conducted according to OECD TG 404, and in compliance with GLP, the test substance, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, was reported to be not irritating to rabbit skin (LPT, 2002).

In the key eye irritation study, conducted according to OECD TG 405, and in compliance with GLP, the test substance, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, was reported to be not irritating to rabbit eyes (LPT, 2002).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system 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

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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-10 to 2002-06-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology, Germany
- Age at study initiation: 4 months
- Weight at study initiation: 1.9-2.4 kg
- Housing: individually in a cage
- Diet: standard diet for rabbits, ad libitum
- Water: drnking water, ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 55 % +/- 5 %
- Photoperiod (hrs dark / hrs light): 12/ 12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye was used as a control group
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Not specified. The test material was applied into the conjunctival sac of the right eye of each animal, the lids were held together for about 1 second. The left eye served as a control. No washing was done.
Observation period (in vivo):
at 1, 24, 48 and 72 hours post-treatment
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: Following application into the conjunctival sac, the lids were held together for 1 second.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp was used prior to administration. 24 hours after administration the eyes were treated with fluorescein and examined.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis 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:
The cornea, iris, conjunctivae were not affected by the instillation of the test substance.
Other effects:
No signs of toxicity were noted during the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
In the eye irritation study, conducted according to OECD TG 405, in compliance with GLP, the test material, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, was reported to be not irritating to the eye of rabbits.
Executive summary:

1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was tested in a valid eye irritation study conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Following single instillation of 0.1 mL of undiluted test material into the conjunctival sac of the right eye of 3 rabbits, no irritation was observed into the test eye of any of the animals. The cornea, iris and conjunctivae were not affected by the test material.

1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was reported to be not irritating under the conditions of the study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key skin irritation study, conducted according to OECD TG 404, and in compliance with GLP, the test substance, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, was reported to be not irritating to rabbit skin (LPT, 2002).

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.

In the key eye irritation study, conducted according to OECD TG 405, and in compliance with GLP, the test substance, 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, was reported to be not irritating to rabbit eyes (LPT, 2002).

Following single instillation of 0.1 mL of undiluted test material into the conjunctival sac of the right eye of 3 rabbits, no irritation was observed into the test eye of any of the animals. The cornea, iris and conjunctivae were not affected by the test material.

1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane was reported to be not irritating under the conditions of the study.


Justification for classification or non-classification

Based on the available data for 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, no classification for skin and eye irritation is required according to Regulation (EC) No. 1272/2008.