Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 17-20, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study has been performed according to OECD guideline and according to GLP principles.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
It should be noted that the study was terminated after 72 hours, since no skin irritation was observed. However, light blue coloration was noted in one animal at study termination. Reversibility of coloration was not established at 72 hours, and the study should not have been terminated.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: dark blue powder
- Stability under test conditions: expected to be stable

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): 19-22
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: mineral oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (0.63 g of the test mixture)
- Concentration (if solution): 80% w/w


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (1 male and 2 female)
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 mineral oil 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:
0.1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Incidence of irritation: erythema: 1/3 after 1h, 0/3 after 24, 48h and 72h; edema: 0/3 after 1, 24, 48 and 72h
Mean severity of irritation: 0.3 after 1h, 0.0 after 24, 48 and 72h.
Other effects:
Although light blue staining was evident at all dose sites during the study, the affected animal was free from dermal irritation within 24 hours.

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.