Reaction mass of decyl acrylate and octyl acrylate

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 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

Results 3

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

Results 4

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.