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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
GLP-compliant study, available as unpublished report, minor restrictions in design in comparison to modern guidelines, but adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize, J.H., Woodard, G., and Calvery, H.O., 1944
Principles of method if other than guideline:
Differs from current testing guidelines by using a 24-hr contact period rather than a 4-hr contact period, use of both intact and abraded skin, and PII calculated using 24- and 72-hr observations instead of 24-, 48- and 72-hr time points.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
BUTASAN, off-white powder
Purity: 99.9 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: 1sf: (NZW), Isaac’s Farm, Litchfield, Illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.91—3.20 kilograms
- Housing: One per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: animals were quarantined for at least five days.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved; then 2 out of 4 test sites abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ± .004 grams
Duration of treatment / exposure:
24 hours
Observation period:
Observations for skin irritation was made after 1 hour, 24 hours and 72 hours after removal of the wrappings.
Number of animals:
3 males and 3 females per dose
Details on study design:
TEST SITE
- Area of exposure: one inch square
- Type of wrap if used: an occlusive wrap of latex rubber secured by bandaging and elastic tape.

REMOVAL OF TEST SUBSTANCE
- The occlusive wrap and gauze patches were removed after approximately 24 hours, and the excess material was wiped from the treated sites of
the animals.

SCORING SYSTEM:
Dermal irritation was scored by the method of Draize (1944), and results were recorded on the first and third days after topical application.
The Primary Irritation Index was calculated by averaging the mean scores at 24 and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24,72 hours
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 72h
Remarks on result:
other: overall score for both intact and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hr
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
other: abraded skin

Applicant's summary and conclusion