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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-03-02 to 1999-03-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method according to EEC method B4, OECD guideline 404 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:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

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
- Analytical purity: >92%
- Lot.: M-350B
- Expiry: 12 February 2000

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, England.
- Age at study initiation: at least 14 weeks of age
- Weight at study initiation: 2.9 to 3.4 kg
- Housing: Individually in stainless steel cages with perforated floors.
- Diet: ad libitum
- Water: ad libitum
-Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS:
-Temperature: 19 to 20°C
- Humidity: 35 to 48%
- Photoperiod: 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

Examination of the treated skin was made on Day 1, 2, 3 and 4. Additional observations were made for two animals on Days 5 through 10.

Number of animals:

3

Details on study design:

TEST SITE
-Area of exposure: 25 mm x 25 mm of dorso-lumbar region
-Type of wrap if used: gauze pad under "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE:
- Washing (if done): Yes, washed with warm water (36ºC) and blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM: According to guidelines
ERYTHEMA AND ESCHAR FORMATION
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading: 4

OEDEMA FORMATION
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (edges raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean 24-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: Mean 24-72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: Mean 24-72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Mean 24-72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Mean 24-72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Mean 24-72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight to well-defined dermal initation (erythema with oedema up to Grade 2) was seen in two animals following removal of the dressings and over the following days, resolving completely by Day 10. In addition, desquamation of the stratum corneum (characterised by dryness and sloughmg) was observed in one of these rabbits. No dermal initation was observed in the remaining rabbit throughout the study.

Any other information on results incl. tables

Dermal reactions:

Rabbit	E= Erythema O= Oedema	Day										Mean 24-72h
		1*	2	3	4	5	6	7	8	9	10
1933 Male	E	1	1	1	1	2	2	1	1	1	0	1.0
	O	1	1	0	0	0	0	0	0	0	0	0.3
	Other	-	-	A	a	a	a	a	a	a	-	-
1934 Male	E	1	2	2	2	2	2	1	1	1	0	2.0
	O	1	2	2	0	0	0	0	0	0	0	1.3
	Other	-	-	A	a	a	a, b	a, b	a, b	a, b	b	-
1935 Male	E	0	0	0	0	-	-	-	-	-	-	0.0
	O	0	0	0	0	-	-	-	-	-	-	0.0
	Other	-	-	-	-	-	-	-	-	-	-	-

*: Approximately 30 minutes after removal of the dressing

a: Patchy response

b: Desquamation of the stratum comeurn (characterised by dryness and sloughing)

-: Not applicable

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to CLP Regulation, the test item is not classified as irritating to the skin.

Executive summary:

A skin irritation study was performed with test item in accordance with EEC Method B4 and OECD Guideline 404. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance (as received) for four hours under semi-occlusive conditions and observed for up to ten days. Slight to well-defined dermal initation (erythema with oedema up to Grade 2) was seen in two animals following removal of the dressings and over the following days, resolving completely by Day 10. The mean 24 -72 hours erythema scores were 1.0, 2.0 and 0.0 and the mean 24 -72 oedmea scores 0.3, 1.3 and 0.0 for each animal respectively. In addition, desquamation of the stratum corneum (characterised by dryness and sloughmg) was observed in one of these rabbits. No dermal initation was observed in the remaining rabbit throughout the study. According to CLP Regulation, the test item is not classified as irritating to the skin.