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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 15-26, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

According to OECD Guideline 404, with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 0-97633 Sulzfeld.
- Weight at study initiation: 1.8 – 2.1 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: 5 days (animal nº 1) and 12 days (animals nº 2 and 3)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19.2 ºC (continuous control and recording).
- Humidity (%): average of 50.1 ºC (continuous control and recording).
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: The surrounding of the administration area served as the untreated control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the test substance
- Concentration (if solution): the test substance was used undiluted.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours after patch removal.

Number of animals:

3 female rabbits.

Details on study design:

TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: a semi-occlusive dressing
- Area of exposure: Median on the dorsal thoracal region.
- % coverage: 2.5 cm x 2.5 cm.
- Type of wrap if used: Samples were spread on cellulose patches and were held in place by fixing them marginally with non irritating tapes. The application sites were covered semiocclusively by a dressing. Access by the animals to the application sites was prevented by a plastic collar.

SCORING SYSTEM: According to guideline 404 (table: Grading of Skin Reactions)

Erythema / Eschar formation
0 No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) or eschar formation (injuries in depth).

Oedema formation
0 No oedema.
1 Very slight oedema (barely perceptible).
2 Slight oedema (edges of area well defined by definite raising).
3 Moderate oedema (raised approximately 1 mm).
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

All areas to be treated with the test substance and alt control areas were normal before the application 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 application sites:

Time after the end of the exposure	Erythema / Eschar animal Nos.			Oedema animal Nos.
	1	2	3	1	2	3
1 h	0	0	0	0	0	0
24 h	0	0	0	0	0	0
48 h	0	0	0	0	0	0
72 h	0	0	0	0	0	0
mean (24-72 h)	0.0	0.0	0.0	0.0	0.0	0.0

Scores of the application sites of animal No. 11 after exposure for 3 min, 1 h and 4 h:

Time after the end of the exposure	Erythema / Eschar Exposure Time			Oedema Exposure Time
	3 min	1 h	4 h	3 min	1 h	4 h
0 min	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 dermal irritation/corrosion study in New Zealand White rabbits treated with a single administration of test article Wasox-MMAC2 (0.5 mL) did not show any sign of erythema/eschar or oedema during the test period and has to be considered "non irritant" for the skin.

Executive summary:

The Acute Dermal Irritation/Corrosion assay for the test substance Wasox-MMAC2 was performed in New Zealand White rabbits. 0.5 mL of the test material was applied to a site of 2.5cm x 2.5cm, of intact skin of 3 rabbits and covered by semi-occlusive dressing. The administration of the test substance was performed in a sequential manner. The first animal was exposed to the test substance stepwise at three sites of the skin: site 1 for three minutes, site 2 for 1 hour and site 3 for 4 hours. As no serious reactions were noted in the first animal, the remaining two animals were exposed to the test substance one week later for 4 hours. The treated areas of the animals were examined for erythema/eschar and oedema as well as other local skin alterations approximately at 1, 24, 48, and 72 hours after patch removal. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

The surrounding of the administration area, i.e. the untreated skin, served as a negative control. The treated areas of the animals did not show any sign of erythema/eschar and oedema during the test period and has to be considered "non irritant" for the skin.