Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute 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: Ferenc Sandor breeder , Kartal, Hungary
- Age at study initiation: adult albino rabbits
- Weight at study initiation: 3147-3283 g
at study termination: 3230-3288 g
- Housing: individually in metal cages.
- Diet (e.g. ad libitum): ad libitum, UNIPLUS standard diet (AGRIBRANDS EUROPE)
- Water (e.g. ad libitum): ad libitum, potable water from automatic self-service water system
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item, in pure state, in a single dose

VEHICLE
No vehicle was applied
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: appr. 6 cm2
- Type of wrap if used: sterile gauze patch fixed with adhesive hypoallergenic plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with body temperature water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs
Irritation parameter:
edema score
Basis:
mean
Remarks:
for each animal
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no signs
Irritant / corrosive response data:
No primary irritation symtoms, like erythema and edema, or other signs occured during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU