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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

19 Nov 1986 - 07 Jan 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The animals were observed for 72 hours only.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Observation period was too short (72 h) to evaluate the reversibility of effects. No data on substance purity were given.

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

Details on test material:

- Name of test material (as cited in study report): SILANE 196 - Méthyltris (méthyléthylcétiminoxy) silane
- Substance type: Ketoxime
- Physical state: Liquid
- Storage condition of test material: Minimum of 19°C.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: No data
- Weight at study initiation: 2.5±0.2 kg
- Housing: Individual in polystyrene cages
- Diet: Rabbit complete pelleted maintenance food, ad libitum (UAR, formula 112, Epinay sur Orge, France)
- Water: Softened and filtered drinking water, ad libitum
- Acclimation period: Minimum of one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19.11.1986 To: 22.11.1986

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48, 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: No data
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: yes, if any test substance was left on the skin
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Erythema (Grade 1) in 2 of 6 animals. No further observations of erythema.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Erythema grade 1 were observed in 6/6 animals after 1 h, and were fully reversible within 48 h in 6/6 animals. No edema reactions were observed throughout the whole study period. Desquamation was still visible at 72 hours in 3 of 6 animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

A reliable study conducted broadly in accordance with OECD 404 and GLP (reliability score 2) found the test material to be non-irritating to the skin of rabbits. Mild, transient erythema was replaced by desquamation that remained in some animals the end of the short observation period (72 h). There was no oedema evident at any time point.