Trisilicon tetranitride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 January 2005 - 4 February 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliance study performed in accordance with international guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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:

Trisilicon tetranitride

EC Number:

234-796-8

EC Name:

Trisilicon tetranitride

Cas Number:

12033-89-5

Molecular formula:

N4Si3

IUPAC Name:

1Si-hexacyclo[3.1.1.0¹,⁴.0²,⁵.0³,⁶.0³,⁷]trisilazane

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Silicon nitride Si3N4
- Analytical purity: >97%
- Lot/batch No.: 2607/04-FS
- Stability under test conditions: In closed container: at least 1 year
- Storage condition of test material: Dry

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.9-2.6 kg
- Housing: Individual caging in metal wire cages, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height. Optimal hygienic conditions.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libiutum
- Acclimation period: 5 days (animal No.61 and 12 days (animals Nos. 62 and 63)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average 19.1 (continuous control and recording)
- Humidity (%): Average 50.7
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 0.5 g of the test substance (the weighed amounts were 503, 500 and 501 mg) and each moistened with 1.0 mL deionised water

Duration of treatment / exposure:

First animal - 3 minutes, 60 minutes, and 4 hours (three treatment sites)
Second and third animals - 4 hours

Number of animals:

3 females (Nos. 61-63)

Details on study design:

TEST SITE
- Area of exposure: Dorsal areas
- Type of wrap if used: gauze patches in size of about 2.5 cmx 2.5 cm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: 63

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: No reversibility could be noted due to no adverse effects.

Results 2

Irritation parameter:

erythema score

Basis:

animal: 63

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: No reversibility could be noted due to no adverse effects.

Results 3

Irritation parameter:

edema score

Basis:

animal: 62

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: No reversibility could be noted due to no adverse effects.

Results 4

Irritation parameter:

erythema score

Basis:

animal: 62

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: No reversibility could be noted due to no adverse effects.

Results 5

Irritation parameter:

erythema score

Basis:

animal: 61

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: No reversibility could be noted due to no adverse effects.

Results 6

Irritation parameter:

edema score

Basis:

animal: 61

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: No reversibility could be noted due to no adverse effects.

Any other information on results incl. tables

The following mean scores were calculated for each animal from thr examinations 24h, 48h and 72h p.a

	Mean scores for Animal No.
	61	62	63
Erythema / Eschar	0.0	0.0	0.0
Oedema	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

From the examinations 24 h, 48 hand 72 h p.a. the Erythema / Eschar and Oedema mean scores calculated for each animal were 0.0.
According to Commission Directive 2001/59/EC "SILICON NITRIDE Si3N4" does not require classification for skin irritation.