Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
according to Guideline

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0,5 ml
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 h and 7 days after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 cm x 10 cm
- % coverage:
- Type of wrap if used: gauze patch


REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure:


SCORING SYSTEM: according to numerical scoring system listed in 2004/73/EC, April 29,2004

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h/48h/72h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h, 48h, 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
all animals
Time point:
other: 24h, 48h, 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h, 48h, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24h, 48h, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item caused a slight red staining of the treated skin. The staining of the skin doesnt affected`the reading of the scores as the skin was flushed with warm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time. No clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance not subject of classification and labelling