2-butanone-O,O',O''-(phenylsilylidyne)trioxime

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-02-10 to 2000-02-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test method according to with EEC method B5, OECD guidelin 405 with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

433-360-6

EC Name:

-

Cas Number:

34036-80-1

Molecular formula:

C18H29N3O3Si

IUPAC Name:

6-{[(butan-2-ylidene)amino]oxy}-3,9-dimethyl-6-phenyl-5,7-dioxa-4,8-diaza-6-silaundeca-3,8-diene

Constituent 2

Reference substance name:

2-butanone-O,O',O''- (phenylsilylidyne)trioxime

IUPAC Name:

2-butanone-O,O',O''- (phenylsilylidyne)trioxime

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report):Phenyltris-(methylethylketoximino)silane
- Physical state: Clear liquid
- Lot no.: M-350B
- Expire time: 1 June 2000

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Initial weight: 2.1 to 3.2 kg
- Age at test initiation: At least 10 weeks of age
- Housing: Individually in metal cages with perforated floors.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS:
-Temperature: 23 to 24°C
- Humidity: <20 to 35%
- Photoperiod: 12 hours of artificial light (0600 - 1800 hours GMT) in each 24 hours period.

In-life dates: from: Feb 10, 2000; To: Feb 14, 2000.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml of the test substance placed in the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.

Duration of treatment / exposure:

Single exposure.

Observation period (in vivo):

1 hour and 1, 2 and 3 days after instillation. Additional observations were made for one animal four days after instillation.

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: According to guidelines.
CORNEAL OPACITY: Degree of density (area most dense taken for reading)
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacreous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4

IRIS:
- Normal: 0
- 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): 1
- No reaction to light, haemorrhage, gross destruction (any or all of these): 2

CONJUNCTIVAE: Redness (refers to palpebral and bulbar conjunctivae)
- Blood vessels normal: 0
- Some blood vessels definitely hyperaemic (injected): 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2
- Diffuse beefy red: 3

EDEMA: Lids and/or nictitating membranes
- No swelling: 0
- Slight swelling (includes nictitating membranes): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half-closed: 3
- Swelling with lids more than half-closed: 4

TOOL USED TO ASSESS SCORE: handheld light

OTHER OBSERVATIONS: Clinical signes: All animals were observed daily for signs of ill health or toxicity.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean 24-72h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean 24-72h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean 24-72h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean 24-72h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean 24-72h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean 24-72h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean 24-72h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean 24-72h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean 24-72h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean 24-72h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean 24-72h

Score:

0

Max. score:

2

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean 24-72h

Score:

0

Max. score:

2

Irritant / corrosive response data:

Dulling of the cornea was evident one hour after dosing only in one of the three treated animals No iridial inflammation was observed in any animal throughout the observation period. Conjunctival inflammation up to Grade 2 in intensity was evident in all three animals one hour after instillation, with the level of response decreasing over the following days before resolving in all instances between three and four days of instillation.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Oculat reactions:

Rabbit	Region of the eye		One hour	Day after installation
				1	2	3	4
100 Female	Cornea	Density	D	0	0	0	0
		Area	4	0	0	0	0
	Iris		0	0	0	0	0
	Conjunctiva	Redness	2	2	1	1	0
		Chemosis	2	0	0	0	0
95 Female	Cornea	Density	0	0	0	0	-
		Area	0	0	0	0	-
	Iris		0	0	0	0	-
	Conjunctiva	Redness	2	1	1	0	-
		Chemosis	2	0	0	0	-
96 Female	Cornea	Density	0	0	0	0	-
		Area	0	0	0	0	-
	Iris		0	0	0	0	-
	Conjunctiva	Redness	2	1	1	0	-
		Chemosis	2	0	0	0	-

D: Dulling of the cornea

-: Not applicable

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In accordance with CLP Regulation, the test substance is not classified as irritating to the eyes.

Executive summary:

An eye irritation study was performed with thest item according to EEC Method B5 and OECD Guideline 405. Three rabbits were each administered a single ocular dose of a volume of 0.1 ml of the test substance and observed for up to four days after instillation. Test item elicited dulling of the cornea (evident one hour after dosing only in one of the three treated animals), no iridial inflammation and transient conjunctival inflammation up to Grade 2 in intensity evident in all three animals one hour after instillation, with the level of response decreasing over the following days before resolving in all instances between three and four days of instillation. The mean 24 -72 hours conjunctivae redness scores were 0.7, 0.7 and 1.3 for each animal. On the basis of these results and in accordance with CLP Regulation, the substance is not classified as irritating to the eyes.