Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD principles of GLP, Annex 2, C (8) 30
Qualifier:
according to
Guideline:
other: U.S Environmental Protection Agency's Good Laboratory Practice Standards, 40 CFR 160
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

In vitro test system

Justification for test system used:
Historically, the New Zealand White albino rabbit has been the animal of choice for evaluating the effect of chemicals on the skin

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
SOURCE ANIMAL
- Sex: Male
- Weight at study initiation: 2010 - 2620g
- Housing: Individually in screen-bottom cages in temperature- and humidity-controlled quarters
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

REMOVAL OF TEST MATERIAL AND CONTROLS
- Observable damage in the tissue due to washing: Material was removed from the test site as throughly as possible without irritating the skin
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST ANIMALS
- Weight at study initiation: 2010 - 2620g
- Housing: Individually in screen-bottom cages in temperature- and humidity-controlled quarters
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 69 -78 °F
- Humidity (%): 61 - 74 %RH

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 4 hours
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material, ADK STAB L-63P, produced no irritation when applied to the skin of six albino rabbits under 4-hour semiccluded conditions.