Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

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

Test material

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet, ad libitum
- Water (e.g. ad libitum): mains tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 28 May 2008 To: 31 May 2008

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
observations made 1, 24, 48 and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 0.5 ml applied under 2.5cm x 2.5cm cotton gauze patch
- Type of wrap if used: cotton gauze, surgical tape, elasticated corset


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton woll soaked in distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: eryhtema/eshar - 0-4, oedema - 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
67549 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
67549 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
67547 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
67548 male
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
67547 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
67548 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of mild irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
The test substance had no effect upon oedema score at any time point. At the 24 and 48 hour evaluations, one rabbit showed erythema (score 1). All findings were resolved at the 72 hour observation time. All treated skin appeared normal at the 72 hour observation period.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Not classified for skin irritation according to EU DSD/DPD or CLP criteria.