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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:
weight of evidence
Study period:
February - March 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FIFRA and TSCA guidelines
Deviations:
no
Principles of method if other than guideline:
This study was conducted to evaluate the dermal irritation produced by test item in rabbits when administered for a 4-hour interval under a semi-occlusive covering and when administered for a 24-hour interval under an occlusive covering.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
reaction mass of decyl acrylate and octyl acrylate
EC Number:
911-295-9
Molecular formula:
C11H20O2 and C13H24O2
IUPAC Name:
reaction mass of decyl acrylate and octyl acrylate
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: hazleton-Dutchland, Inc. Denver, Pennsylvania
- Age at study initiation: yound adult
- Weight at study initiation: no data
- Housing: individually in suspeded and stainless steel
- Diet (e.g. ad libitum): Lab rabbit chow HB, ad libitum
- Water (e.g. ad libitum): automatic watering system, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-70 °F
- Humidity (%): 30-70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
other: semi-occlusive (4hr) or occlusive (24h)
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml of test material per site
Duration of treatment / exposure:
4 or 24 hours
Observation period:
14 days
Number of animals:
same 6 animals for 4h and 24hr exposure.
Details on study design:
The test material was applied to four sites of each animal. Two sites (one intact, one abraded) were semi-occluded for 4 hours and two sites (one intact, one abraded) were occluded for 24 hours.
Clipping: On the day before dosing the hair of each rabbit was closely clipped from the dorsal area of the trunk with an alectric clipper, so as to expose at least 10% of the body surface area.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.56
Max. score:
4
Reversibility:
fully reversible within: 14d
Remarks on result:
other: 4h exposure / intact skin: Individual scores: 1-1.67-1-2-1.67-2
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 4h exposure / intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 14d
Remarks on result:
other: 24h exposure / intact skin: Individual scores: 1.33-2-1.67-1.67-1.67-1.67
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 14d
Remarks on result:
other: 24h exposure / intact skin: Individual scores: 1-0-0.67-0.33-0-0.33
Irritant / corrosive response data:
Test substance produced generally mild, reversible dermal irritation. Slight erythema without edema was seen at both intacty and abraded sites exposed for 4 hours under a semi-occlusive covering. Slight erythema with or without edema was seen at both intact or abraded sites exposed for 24 hours under an occlusive covering. The primary irritation index for the 24-hour exposures was 2.2.
all animals were free of significant irritation within 3 to 14 days, at the 4- hours exposure sites. Except for very sight erythema seen at a few sites, all animals were free of significant irritation within 7 to 14 days, at the 24-hours exposure sites.

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
The test item produced mild and reversible dermal irritation after 4 hours of exposure on intact skin.
Executive summary:

This study was conducted to evaluate the dermal irritation produced by test item in rabbits when administered for a 4-hour interval under a semi-occlusive covering and when administered for a 24-hour interval under an occlusive covering.

The test item produced mild and reversible dermal irritation after 4 hours of exposure on intact skin.

Slight erythema without edema was seen at both intacty and abraded sites exposed for 4 hours under a semi-occlusive covering. Slight erythema with or without edema was seen at both intact or abraded sites exposed for 24 hours under an occlusive covering. The primary irritation index for the 24-hour exposures was 2.2. All animals were free of significant irritation within 3 to 14 days, at the 4- hours exposure sites. Except for very sight erythema seen at a few sites, all animals were free of significant irritation within 7 to 14 days, at the 24-hours exposure sites.

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