A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 10-21, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

According to OECD Guideline 405, with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime

EC Number:

458-680-3

EC Name:

A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime

Cas Number:

797751-44-1

Molecular formula:

not applicable, multiconstituent substance

IUPAC Name:

3-ethenyl-3-methoxy-6-methyl-2,4-dioxa-5-aza-3-silahept-5-ene; 5-ethenyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene; 5-ethenyl-5-methoxy-2,8-dimethyl-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 2.2 – 2.3 kg
- Housing: Individual caging in metal wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days (animal nº 51) and 14 days (animal nº 52 and nº 53)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19.0 ºC
- Humidity (%): average of 51.7%
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL of test substance

Duration of treatment / exposure:

72 hours (the treated eyes were not washed)

Observation period (in vivo):

1, 24, 48 and 72 hours after the administration of the test substance

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: eye irritations were scored according to guideline 405

CORNEA
Opacity : degree of density (area most dense is taken for reading).
0 No ulceration or opacity.
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre),
details of iris clearly visible.
2 Easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.

IRIS
0 Normal.
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia
or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together).

CONJUNCTIVAE

Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye).
0 Blood vessels normal.
1 Some blood vessels definitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.

Chemosis: lids and/or nictating membranes.
0 No swelling.
1 Any swelling above normal (includes nictating membranes).
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed

TOOL USED TO ASSESS SCORE: animals were examined using and otoscope lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

Opacity(degree of density)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: mean scores of animals 51, 52, and 53

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: mean scores of animals 51, 52, and 53

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: 51

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: mean

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: 52

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: mean

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: 53

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: mean

Results 6

Irritation parameter:

chemosis score

Remarks:

lids and/or nictating membranes

Basis:

animal: 51

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

chemosis score

Remarks:

lids and/or nictating membranes

Basis:

animal: 52

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

chemosis score

Remarks:

lids and/or nictating membranes

Basis:

animal: 53

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: mean

Irritant / corrosive response data:

Reversibility of any observed effect: all changes observed were fully reversible within 3 days
After the instillation of the test substance the following findings were made:
- Corneae and irises were not affected.
- Conjunctivae, redness (a score 1) was noted in all animals from 24 h after application (p.a.) onwards until a maximum of 48 h p.a.
- Conjunctivae, chemosis (a score 1) was observed in 2/3 animals only 1 h (p.a.). A scored of 3, later on decreasing to 1, was noted in 1/3 animals from 1h p.a. onwards until 48 h p.a.

Other effects:

Ocular discharge was noted in 2/3 animals from 1h onwards until a maximum of 24 h after test substance application.

Any other information on results incl. tables

Scores of the test eyes:

   Examination of corneae, irises and conjunctivae. Individual data and means.*
               

							Conjunctivae
Time after instillation (p.a.)	Corneae animal No.			Irises animal No.			Redness animal No.			Chemosis animal No.
	51	52	53	51	52	53	51	52	53	51	52	53
1 h	0	0	0	0	0	0	0	0^2)	0^3)	1	1	3
24 h	0	0	0	0	0	0	1	1	1^2)	0	0	2
48 h	0	0	0	0	0	0	0	0	1	0	0	1
72 h	0	0	0	0	0	0	0	0	0	0	0	0
mean (24-72 h)	0.0	0.0	0.0	0.0	0.0	0.0	0.3	0.3	0.7	0.0	0.0	1.0

²⁾ Discharge with moistening of the lids and hairs just adjacent to the lids.

³⁾ Discharge with moistening of the lids and considerable area around the eye.

*Dermal alterations were scored according to OECD guideline nº 405.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified as eye irritant (CLP Regulation EC no. 1272/2008)

Conclusions:

No ocular lesions were observed at 72 hours.

Executive summary:

The Acute Eye Irritation/Corrosion study for the test substance was performed in New Zealand White rabbits. 0.1 mL of the test material was administrated per animal into the conjunctival sacs of the right eyes. The eyes were held closed for about one second to prevent loss of the test substance. The left eyes remained untreated and served as a control. The administration of the test substance was performed in a sequential manner. The first animal was exposed to the test substance, as no evidence for serious damage to the eye of the animal was found during the initial 72 h observation period, the test substance was administrated to the others two animals. Both whole eyes of the animals were examined (especially the corneae, the irises and the conjunctivae) within 24 h before the instillation and approximately 1, 24, 48, and 72 hours after test substance administration. Eye irritations were scored according to OECD guideline nº 405.

No ocular lesions were observed at 72 hours.