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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-09-05 to 1989-09-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-iodo-2-propynyl butylcarbamate
EC Number:
259-627-5
EC Name:
3-iodo-2-propynyl butylcarbamate
Cas Number:
55406-53-6
Molecular formula:
C8H12INO2
IUPAC Name:
3-iodoprop-2-yn-1-yl butylcarbamate
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: P-8907-4914-P100

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark under ambient conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited
- Age at study initiation: young adult
- Housing: individually in aluminium cages with grid floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 d

ENVIRONMENTAL CONDITIONS
- Temperature: mean 18 °C
- Humidity: mean 65 %
- Photoperiod: 12 h (07:00 - 19:00) light; 12 h dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g moistened with water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 males, 3 females
Details on study design:
TEST SITE
- Area of exposure: dorsal area of trunk
- coverage: 2.5 cm x 2.5 cm gauze patch
- Type of wrap if used: micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing: skin was wiped with damp tissues
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Skin reactions were assessed 1, 24, 48 and 72 h after patch removal

SCORING SYSTEM:
According to EPA recommended scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: no further observations performed after 72 h post exposure
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight - moderate erythema (score 1 and 2) and slight oedema (score 1) were noted in 2 of the 6 rabbits 24 h after patch removal with slight erythema persisting in one rabbit until the 72 h assessment. Latter showed a decreasing trend in erythrema score.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following a 4 h semi-occlusive exposure to the test item it is concluded that this material is not considered to be irritant to rabbit skin.
Executive summary:

The primary skin irritation potential of the test material was investigated in New Zealand White rabbits.

Following a 4 h semi-occlusive exposure of the test item slight-moderate erythema and slight oedema were noted in 2 rabbits 24 h after patch removal, with slight erythema persisting in one rabbit until the 72 h assessment. Latter showed a decreasing trend in erythrema score. It remains unclear if longer observation period could have revealed full reversibilty.