Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 24-27, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed in accordance with OECD guideline 404 (1992) and meets the requirements of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CORSAIR CLEAR 12 resin
- Physical state: waxy, white solid
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ, USA
- Age at study initiation: young adult
- Housing: singly housed
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with water
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100
- Type of wrap if used: 4-ply gauze pad wrapped with Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped with ethanol and water and a clean towel
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
average erythema + average edema
Time point:
other: 1, 24, 48 and 72 hours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Incidence of irritation: erythema: 2/3 after 24h, 1/3 after 48h, 0/3 after 72h; edema: 1/3 after 24h, 0/3 after 48 and 72h
Mean severity of irritation: 1.0 after 24h, 0.3 after 48h, 0.0 after 72h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the classification system (Draize scoring system) used, the test substance is classified as non-irritating to the skin.