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Toxicological information

Eye irritation

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Administrative data

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

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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

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

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.