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Registration Dossier
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EC number: 222-222-9 | CAS number: 3390-61-2
Endpoint summary
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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
Reference
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.
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