A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)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:

results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

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'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

EC Number:

460-110-3

EC Name:

A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime

Cas Number:

797751-43-0

Molecular formula:

not applicable, multiconstituent substance

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Wasox-MMAC2
- Physical state: Clear liquid.
- Lot/batch No.: 1000024854.
- Expiration date of the lot/batch: December 2005.
- Storage condition of test material: Storage under a nitrogen atmosphere at ambient temperature
- Other: Handling precautions: Exothermic reaction with water or humidity from the air.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Weight at study initiation: 2.0 – 2.6 kg
- Housing: Individual caging in metal wire cages, 79 cm x 59 cm bottom area, 38 cm height.
- Diet (e.g. ad libitum): ad libitum (Altromin 2123)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 7 days (animal nº 41) and 14 days (animal nº 42 and nº 43)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19.0 ºC (continuous control and recording).
- Humidity (%): average of 51.7% (continuous control and recording).
- 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:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of test substance
- Concentration (if solution): undiluted.

Duration of treatment / exposure:

72 hours

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:
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: otoscope lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

The untreated eyes (control eyes) were normal at each observation time.
The eyes, treated with the test substance (test eyes) were normal before the instillation and at each observation time.

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Scores of the test eyes:

							Conjunctivae
Time after instillation (p.a.)	Corneae animal No.			Irises animal No.			Redness animal No.			Chemosis animal No.
	41	42	43	41	42	43	41	42	43	41	42	43
1 h	0	0	0	0	0	0	0	0	0	0	0	0
24 h	0	0	0	0	0	0	0	0	0	0	0	0
48 h	0	0	0	0	0	0	0	0	0	0	0	0
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	0.0	0.0	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The acute eye irritation study in New Zealand White rabbits treated with a single administration of test article Wasox-MMAC2 (0.1 mL) has to be considered "non irritant" for the eye since no ocular lesions (cornea, irises, redness and chemosis) were observed during the 72 hours of exposure.

Executive summary:

The Acute Eye Irritation/Corrosion study for the test substance Wasox-MMAC2 was performed according to OECD Guideline 405 in New Zealand White rabbits. Firstly the test substance was administered to one animal. As there was no corrosive or severe irritant effect observed during the initial 72 h, the test substance was administered to two additional animals one week later. 0.1 mL of test item was instilled into the conjunctival sac of right eye of each of 3 rabbits (the left eyes remained untreated and served as a control). 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. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No ocular lesions (cornea, irises, redness and chemosis) were observed during the 72 hours of exposure. The substance has to be considered "non irritant" for the eye.