Reaction mass of decyl acrylate and octyl acrylate

Endpoint summary

Description of key information

A lot of old studies are available on the reaction mass of octyl and decyl acrylate to evaluate the irritating potential to skin and eyes.

Based on the weight of evidence, the registered substance is considered to be slightly irritating to skin and eyes, without CLP classification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

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

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

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.

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.

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.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

August - September 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: summit view farms, hazleton, 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

Type of coverage:

other: semi-occlusive (4hr) or occlusive (24h)

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

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 (3 males and 3 females) 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.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.88

Max. score:

4

Reversibility:

fully reversible within: 10d

Remarks on result:

other: 4h exposure / intact skin: Individual scores: 2-2-2-2-2-1.33

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:

2.33

Max. score:

4

Reversibility:

not fully reversible within: 14d

Remarks on result:

other: 24h exposure / intact skin: Individual scores: 4-2-2-2-2-2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.16

Max. score:

4

Reversibility:

fully reversible within: 14d

Remarks on result:

other: 24h exposure / intact skin: Individual scores: 1.67-0.67-1.33-1.33-1.33-0.67

Irritant / corrosive response data:

Irritation was generally mild and reversible at the sites exposed for 4 hours under a semi-occlusive covering and mild and reversible at most sites exposed for 24 hours under an occlusive covering.
Irritation seen at the 4- hour sites was very slight (barely perceptible) or slight erythema with little or no edema which subsided within 7 to 14 days.
At the 24-hour sites, one animal exhibited superficial necrosis (intact site only) and five exhibited only slight erythema with edema which subsided with 7 to 14 days. The primary irritation index for the 24-hour exposure is 3.1.

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 adiministered 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.

Mild and reversible at most sites exposed for 24 hours under an occlusive covering. Irritation seen at the 4- hour sites was very slight (barely perceptible) or slight erythema with little or no edema which subsided within 7 to 14 days. At the 24-hour sites, one animal exhibited superficial necrosis (intact site only) and five exhibited only slight erythema with edema which subsided with 7 to 14 days.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

October 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

This study was conducted to evaluate the dermal irritation produced by test item in rabbits.

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Observation period:

72 hours after exposure

Number of animals:

6 (3 males 3 females)

Details on study design:

exposure on the right front

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

2.6

Max. score:

4

Remarks on result:

other: individual score: 4-2-2-3-2-2

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

1.33

Max. score:

4

Remarks on result:

other: individual score: 2-1-2-1-1-1

Irritant / corrosive response data:

Test substance produced moderate dermal irritation. All animals exhibited mild to moderate or severe erythema (one animal exhibited superfical necrosis) with edema.

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

August / September 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

To evaluate the eye irritation potential for the test substance, the right eyes of 4 animals were exposed to the test item for 24 hours. Left eye served as control. The eye's animals were examinated 24 hours and 7 days after exposure, and the score of irritation were calculated.

GLP compliance:

not specified

Species:

rabbit

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

no data

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

at 24 hours and day 7 after exposure.

Number of animals or in vitro replicates:

4

Details on study design:

Right eyes of animals were exposed to the test item. Left eye served as control.
Score of each effect were noted, eyes are not rinsed.

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

4 rabbits

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: individual scores: 1-1-1-1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

4 rabbits

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: individual scores:1-1-1-1

Irritation parameter:

iris score

Basis:

mean

Remarks:

4 rabbits

Time point:

24 h

Score:

0

Max. score:

2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

4 rabbits

Time point:

24 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

All four animals exhibited slight conjunctival irritation, four exhibited iridial changes and two exhibited slight corneal changes at 14 hours. Except for slight discharge noted in one animal, all animals were free of ocular abnormalities by Day 7.

Interpretation of results:

GHS criteria not met

Conclusions:

Test substance produced a mild reversible ocular irritation.

Executive summary:

To evaluate the eye irritatiion potential fo the test substance, the right eyes of 4 animals were exposed to the test item for 24 hours. Left eye served as control. The eye's animals were examinated 24 hours and 7 days after exposure, and the score of irritation were calculated. Slight effects were observed on the conjunctivae (redness and chemosis). These effects were reversible within 7 days. However no effect was observed on iritis and cornea. Based on the results, the test substance produced a mild reversible ocular irritation.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

October 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

To evaluate the eye irritation potential for the test substance, the right eyes of 4 animals were exposed to the test item for 24 hours. Left eye served as control. The eye's animals were examinated 24 hours and 7 days after exposure, and the score of irritation were calculated.

GLP compliance:

not specified

Species:

rabbit

Vehicle:

unchanged (no vehicle)

Observation period (in vivo):

at 24 hours and day 7

Number of animals or in vitro replicates:

4 rabbits (2 males 2 females)

Details on study design:

the right eye were exposed and not rinsed

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24 h

Score:

0.5

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: individual score: 1-0-1-0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

3

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Test item was essentially non-irritating to the eye. The only ocular irritation seen was slight conjunctival rednee in two of the four animals at 24 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on these results, the test item was essentially non-irritating to the eye.

Executive summary:

To evaluate the eye irritation potential fo the test substance, the right eyes of 4 animals were exposed to the test item for 24 hours. Left eye served as control. The eye's animals were examinated 24 hours and 7 days after exposure, and the score of irritation were calculated. Slight effects were observed on the conjunctivae (redness). These effects were reversible within 7 days. However no effect was observed on iritis and cornea. Based on the results, the test substance produced a mild reversible ocular irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Three in vivo studies are available on the reaction mass of octyl and decyl acrylate. All the studies were performed on rabbit and showed a mild and reversible skin irritation. So based on the weight of evidence, the reaction mass of octyl and decyl acrylate is considered to be slightly irritating on skin.

Eye irritation

Two in vivo studies are available on the reaction mass of octyl and decyl acrylate.

In the first study, the right eyes of 4 animals were exposed to the test item for 24 hours. Left eye served as control. The eye's animals were examinated 24 hours and 7 days after exposure, and the score of irritation were calculated. Slight effects were observed on the conjunctivae (redness and chemosis). These effects were reversible within 7 days. However no effect was observed on iritis and cornea.

Based on the results, the test substance produced a mild reversible ocular irritation.

In the second assay, the right eyes of 4 animals were exposed to the test item for 24 hours. Left eye served as control. The eye's animals were examinated 24 hours and 7 days after exposure, and the score of irritation were calculated. Slight effects were observed on the conjunctivae (redness). These effects were reversible within 7 days. However no effect was observed on iritis and cornea. Based on the results, the test substance produced a mild reversible ocular irritation.

So based on the weight of evidence, the reaction mass of octyl and decyl acrylate is not considered to be a very slightly eye irritating.

Justification for classification or non-classification

Based on the available data, no classification for skin/eye irritation is required according to the Regulation EC no.1272/2008.