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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:
Dec 18, 1201 to Jan 10, 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study according to OECD protocol, no deviations. - Test substance identified only by brand name and lot number , composition not specified in report, but confirmed by study owner to be an approximately 50/50 mixture of 2,4,6,8,10-pentamethylcyclopentasiloxane (CAS 6166-86-5) and 2,4,6,8-tetramethylcyclotetrasiloxane (CAS 2370-99-0)

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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- three young adult rabbits, 2 females, one male, at least 12 weeks old
- weight 2531-2749 at study initiation
- identification by eartag & cage card
- housed in individual suspended cages
- inspection upon aarival; acclimatisation for at least 7 days, observed twice dayly
- Diet: Certified Rabbit LabDiet(r) 5322 ~a50 gr/animal/day. Tap water at lib. Food and water regularly analysed
- controlled temperature (69-71 degr. F), humidity (50-64%) light (12/12) and ventilation (10-15 changes / days)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml /eye
Duration of treatment / exposure:
undefined. eyes were not washed at 1 hr post-treatment or later.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
OBSERVATIONS
- twice daily for mortality
- body weights at beginning and end of study.
Ocular Observations:
before dosing and at 1, 24, 48 and 72 hrs, both eyes were observed by means of an ophthalmoscope for ocular abnormalities Pre-dosing and at 72 hrs observation included use of sodium fluoerescein for detection of corneal defects. Scoring according to Draize. Only animals without any ocular abnormalities were used in the study

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
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
not fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
minimal redness of the coniunctivae in all animals at 4,24 and 48 hrs after instillation, completely reversible at 72 hrs
minimal chemosis at 4 hrs after instillation, completely reversible within 24 hrs
Other effects:
No other effects were observed at any timepoint . No weight loss, no mortality

Any other information on results incl. tables

Individual scores and mean scores over 24,48 an d 72 hrs:



1 hr

24 hr

48 hr

72 hr

Mean score 24,48,72 hrs

Animal nr 34586, M

Cornea opacity

0

0

0

0

0

Cornea area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

redness

1

1

1

0

0,7

Conjunctivae

chemosis

1

0

0

0

0

Conjunctivae

discharge

0

0

0

0

0

Animal nr. 34595, F

Cornea opacity

0

0

0

0

0

Cornea area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

redness

1

1

1

0

0,7

Conjunctivae

chemosis

1

0

0

0

0

Conjunctivae

discharge

0

0

0

0

0

Animal nr. 34594, F

Cornea opacity

0

0

0

0

0

Cornea area

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

redness

1

1

1

0

0,7

Conjunctivae

chemosis

1

0

0

0

0

Conjunctivae

discharge

0

0

0

0

0

Individual body weights:

Animal nr

Sex

At initation

At 72 hrs

34586

male

2744

2834

34596

Female

2531

2720

34594

Female

2684

2695

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The mixture of structurally analogous substances 2,4,6,8,10-pentamethylcyclopentasiloxane (CAS 6166-86-5) and 2,4,6,8-tetramethylcyclotetrasiloxane (CAS 2370-99-0) produced minimal conjunctival redness at 4, 24 and 48 hrs and minimal chemosis at 4 hrs, all fully reversible. Based on structural analogy, the conclusion applies directly to the registered substance as well as indirectly by read-across from the analogue which is also present in the mixture. Based on the criteria in the CPL Regulation, the substance need not be classified as an eye irritant
Executive summary:

The mixture of structurally analogous substances 2,4,6,8,10-pentamethylcyclopentasiloxane (CAS 6166-86-5) and 2,4,6,8-tetramethylcyclotetrasiloxane (CAS 2370-99-0) was tested in an in vivo eye irritation test according to OECD 405 under GLP. The mixture produced minimal conjunctival redness at 4, 24 and 48 hrs and minimal chemosis at 4 hrs, all fully reversible. The conclusion applies directly to the registered substance as well as indirectly by read-across from the structural analogue which is also present in the mixture. Based on the criteria in the CPL Regulation, the substance need not be classified as an eye irritant