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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

02 Aug - 05 Aug 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 hour occlusive exposure

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 oximono silane
- Substance type: Alkoxysilane
- Physical state: colorless, viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pine Acres Rabbitry, W. Brattleboro, VT
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: single housing
- Diet: Charles River Rabbit Formula, Lot W1 3151; Agway Rabbit Prolab Formula, Lot W1 3189
- Water: tap water, ad libitum
- Acclimation period: at least 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 50±15
- Air changes (per hr): 12-16
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: control patches (+ve and -ve) are included on each animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points: 1, 24, 48 h (after completion of exposure)

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch sealed with plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing: excess test substance was wiped
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 1, 24, 48 h, after completion of exposure

Score:

0.5

Max. score:

8

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test substance caused erythema (Grade 1) to 4 of 6 animals 1 h after removal of the patch. Erythema resolved at 3 sites by 24 h and at the remaining site by 48 h. Edema (Grade 1) was observed at the 4 sites displaying erythema at 1 h after patch removal. The edema had resolved at all 4 sites by 24 h. The Primary Dermal Irritation Index (mean of 1, 24, 48 h, following removal of the patch) was 0.5. The PDII for the negative control (untreated patch) was 0.0, and for the positive control (1% sodium lauryl sulphate) was 6.1.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

CLP Implementation.

Conclusions:

A well reported, well conducted but non-standard study, with GLP, identified slight, transient effects to rabbit skin from 24-h occluded contact with the test material. The effects were fully reversible within 48 h, thus the test substance is considered not to be irritant to the skin.

Executive summary:

A skin irritation study was conducted with a method equivalent to OECD 404 according to GLP standards. Six New Zealand white rabbits were exposed to 0.5 mL test substance (undiluted) for 24 hours under a occlusive coverage. The observation period was 72 hours and reading time points at 1, 24 and 48 hours after completion of exposure. Positive and negative control patches were included on each animal. The reactions were scored according to Draize system. The test substance caused erythema (Grade 1) to 4 of 6 animals 1 h after removal of the patch. Erythema resolved at 3 sites by 24 h and at the remaining site by 48 h. Edema (Grade 1) was observed at the 4 sites displaying erythema at 1 h after patch removal. The edema had resolved at all 4 sites by 24 h. The Primary Dermal Irritation Index (mean of 1, 24, 48 h, following removal of the patch) was 0.5. The PDII for the negative control (untreated patch) was 0.0, and for the positive control (1% sodium lauryl sulphate) was 6.1. The substance was concluded to be non-irritating to the skin.