Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h p.a.
Score:
0
Max. score:
0
Irritation parameter:
other: Oedema
Basis:
mean
Time point:
other: 24, 48 and 72 h p.a.
Score:
0
Max. score:
0

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:
Migrated information 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.