Registration Dossier

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:
2007

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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: an accredited supplier, but otherwise not stated
- 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: 7 March 2007 To: 14 March 2007

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, and 7 days 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:
erythema score
Basis:
other: total for 3 animals
Time point:
other: 24 hours
Score:
5
Max. score:
12
Irritation parameter:
erythema score
Basis:
other: total for 3 animals
Time point:
other: 72 hours
Score:
3
Max. score:
12
Remarks on result:
other: one animal showed loss of skin elasticity, one showed loss of skin elasticity and flexibility
Irritation parameter:
erythema score
Basis:
other: total for 3 animals
Time point:
other: 7 days
Score:
0
Max. score:
12
Remarks on result:
other: one animal showed slight desquamation
Irritation parameter:
edema score
Basis:
other: total for 3 animals
Time point:
other: 24 hours
Score:
3
Max. score:
12
Irritation parameter:
edema score
Basis:
other: total for 3 animals
Time point:
other: 72 hours
Score:
1
Max. score:
12
Irritation parameter:
edema score
Basis:
other: total for 3 animals
Time point:
other: 7 days
Score:
0
Max. score:
12
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: slightly irritant

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.