Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-10-08 to 2002-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, according to OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-860-9
EC Name:
-
Cas Number:
474510-57-1
Molecular formula:
C21 H24 O4
IUPAC Name:
2-hydroxy-1-(4-{[4-(2-hydroxy-2-methylpropanoyl)phenyl]methyl}phenyl)-2-methylpropan-1-one
Details on test material:
- Description: Slightly yellow powder
- Purity: 94.1%
- Stability of test item: Stable under storage conditions
- Storage conditions: In the original container, at room temperature (range of 17-23 °C), protected from light. The test item is light sensitive and was handled in a dark room.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes; F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 10 weeks (male); 20 weeks (females)
- Weight at study initiation: male: 2173 g; female: 3018 g (mean)
- Housing: Individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water: Community tap water from Fullinsdorf, ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70%
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours light and 12 hours dark

IN-LIFE DATES: From: 08-Oct-2002 To: 17-Oct-2002

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g/0.1 mL

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (reading performed at 1, 24, 48 and 72 hours)
Number of animals:
3 (animals of both sexes were used)
Details on study design:
TEST SITE
- Area of exposure: 100 cm2 (10 cm x 10 cm)
- % coverage: no data
- Type of wrap if used:semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water to clean the application site
- Time after start of exposure: 4 hours

SCORING SYSTEM: the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
female
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
- Irritation:
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0).
- Corrosion:
No corrosive effects were evident on the skin.
Other effects:
- Viability/mortality/clinical signs:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Coloration:
No irreversible alterations of the treated skin were observed.
- Body weights:
The body weights of all rabbits were considered to be within the normal range of variability.

Any other information on results incl. tables

The test item is considered to be "not irritating" to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information