Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 Aug 1983 - 11 Aug 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline and was conducted in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 2002

Deviations:

yes

Remarks:

No sequential testing. Use of 9 animals (3 rinsed, 6 not rinsed).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butan-2-one O,O',O''-(methylsilylidyne)trioxime

EC Number:

245-366-4

EC Name:

Butan-2-one O,O',O''-(methylsilylidyne)trioxime

Cas Number:

22984-54-9

Molecular formula:

C13H27N3O3Si

IUPAC Name:

butan-2-one O,O',O''-(methylsilanetriyl)oxime

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Methyl Oximino Silane
- Physical state: colorless, viscous liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Pine Acres Rabbitry, Brattleboro, VT, USA
- Age at study initiation: 10-12 wk
- Weight at study initiation: 2.1-2.7 kg (based on age not weight)
- Housing: single housing
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: quarantine at least 2 wk, no further data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3
- Humidity (%): 50±15
- Air changes (per hr): 12-16
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1983-08-04 To: 1983-08-11

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye is generally used as the control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: neat

Duration of treatment / exposure:

3 rabbits had the treated eye washed for 1 min after 20 secs. The remaining 6 were unwashed.

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48, 72 h and daily until day 7

Number of animals or in vitro replicates:

9 (3 washed, 6 unwashed)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the eyes of 3/9 were washed
- Time after start of exposure: 20 seconds

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.16

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Corneal opacity, circumcorneal injection of the iris, conjunctival redness, chemosis, and discharge was observed in 5 of 6 unirrigated eyes within 24 hours of treatment. All irritation associated with exposure to the test substance was reversible within 7 days. Rinsing test eyes with tap water 20 seconds following instillation appeared to be beneficial in that it prevented positive ocular irritation in 2 of the 3 additional animals. For details see table 1.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time until effects no longer evident (observations continued to day 7)

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0/0/0/0	1/0/1/0/1/1	1/1/1/0/1/1	1/2/2/1/1/2
24 h	2/2/2/0/2/2	0/1/0/0/1/1	1/1/1/0/1/1	0/1/0/0/1/1
48 h	1/1/2/0/2/1	0/0/0/0/1/1	1/1/1/0/1/1	0/0/0/0/0/0
72 h	0/0/1/0/0/0	0/0/0/0/0/0	0/0/0/0/0/1	0/0/0/0/0/0
Average 24h, 48h, 72h	1	0.3	0.6	0.16
Reversibility*	c	c	c	c
Time for reversion	Day 4	72 h	Day 4	48 h

* Reversibility: c. = completely reversible;n.c.= not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In a reliable eye irritation study, conducted in a manner similar to OECD 405 and with GLP (RL2) butan-2-one O,O',O''-(methylsilylidyne)trioxime was irritating to the eyes of rabbits based on 4/6 animals having a mean (24, 48 and 72 hour) score ≥1 for corneal effects.