Reaction mass of dodecyl acrylate and tridecyl acrylate

Endpoint summary

Description of key information

No irritation study is available on the registered substance (reaction mass of C12 -C13 acrylate). However the data are available on an analogue substance (reaction mass of C12 -C14 acrylate).

Indeed, Laurylacrylate (C12 -C14 acrylate) is slightly irritating to the skin or but not irritating to the eyes in rabbit's studies.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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:

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL of the undiluted test material

Duration of treatment / exposure:

24 hour(s)

Observation period:

Readings were performed after 24 and 72 hours. If, at the second reading, distinct irritation was observed a third reading was performed after seven days. After the final reading all rabbits were killed and, in the case of eschar formation, the scab was removed to examine the nature of the underlying tissue damage.

Number of animals:

12 (6 animals were treated on intact skin)

Details on study design:

TEST PROCEDURE Primary irritation to the skin was measured by a patch-test technique on the abraded and intact skin of albino rabbits. Twelve healthy adult New Zealand White albino rabbits were used for the test substance. Pretreatment: 24 hours prior to applying the material, the hair was removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.
Application procedure: The test substance was brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. Abrasions: The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluation of skin reactions: Skin reactions were evaluated by the method of Draize (1944).Draize (1944). J. Pharmacol. 82: 377-390 Calculation of Primary Irritation Index: A Primary Irritation Index was calculated as follows: all erythema and edema scores obtained after 24 and 72 hours (48 scores) are added together and divided by 24. The Primary Irritation Index was descriptively expressed according to the following classification: 0.0 - 0.5 non-irritant 0.6 - 3.0 slight irritant 3.1 - 5.0 moderate irritant 5.1 - 8.0 severe irritant

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24, 72 h

Score:

2.4

Max. score:

8

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 27 h

Score:

1.42

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 h

Score:

0.6

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 72 h

Score:

1.59

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: abraded skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 h

Score:

1.07

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: abraded skin

Irritant / corrosive response data:

After 24 hours, intact skin : very slight or well-defined thema and very slight edema .
After 24 hours, abraded skin: very slight or well-defined erythema, slight ischemia and slight edema.
After 72 hours, intact skin: very slight or well-defined erythema, slight scaliness and very slight edema.
After 72 hours, abraded skin: very slight erythema, slight scaliness and very slight edema.
On the abraded skin the test compound caused edema to a slightly higher degree than on the intact skin .
As to the other dermal effects observed there were no differences between reactions of the intact skin and those of the abraded skin .

Generally, the following dermal effects were observed:
After 24 hours, intact skin: very slight or well-defined erythema and  very slight edema.
After 72 hours, intact skin: very slight or well-defined erythema, slight  scaliness and very slight edema.
On the abraded skin the test compound caused edema to a slightly higher  degree than on the intact skin.
As to the other dermal effects observed, there were no differences  between reactions of the intact skin and those of the  abraded skin.

Individual and average skin irritation scores:

	Intact skin					Abraded skin
No. Animal	24 h		72 h		No. animal	24 h		72 h
	A	B	A	B		A	B	A	B
1	2	1	1	0		2	2	1	1
2	2	1	1	0		4	2	1	0
3	1	0	1	0		2	2	1	0
4	1	1	1	0		2	2	1	1
5	2	1	2	1		2	2	1	0
6	2	1	1	1		1	1	1	0
average	1.7	0.8	1.2	0.3		2.1	1.8	1.0	0.3
Sum	2.5		1.5			4.0		1.3

A: erythema
B: edema


Mean values over 24 and 72 hours (intact skin):

No. Rabbit	Erythema	Edema
1	1.5	0.5
2	1.5	0.5
3	1.0	0.0
4	1.0	0.5
5	2.0	1.0
6	1.5	1.0
average	1.42	0.6

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Based on the available data, the test item is considered to be slightly irritating in rabbit after 4 hours of exposure (on intact skin).

Executive summary:

Primary irritation to the skin was measured by a patch-test technique on the abraded and intact skin of albino rabbits. Twelve healthy adult New Zealand White albino rabbits were used for the test substance. 24 hours prior to applying the material, the hair was removed from the backs of the animals with an electric clipper in such a way as to avoid  abrasions. The test substance was brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. Skin reactions were evaluated by the method of Draize (1944). All erythema and edema scores obtained after 24 and 72 hours (48 scores) were determined.

Mean values over 24 and 72 hours (intact skin) were 1.5 -1.5 -1.0 -1.0 -2.0 -1.5 for erythema score, and 0.5 -0.5 -0.0 -0.5 -1.0 -1.0 for oedema score. Based on the available data, the test item is considered to be slightly irritating in rabbit after 4 hours of exposure (on intact skin).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Method: Draize Test

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

Amount applied: 0.1 mL

Duration of treatment / exposure:

168 hour(s)

Number of animals or in vitro replicates:

6

Details on study design:

Comment: not rinsed

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

No eye irritation was observed in this study 24 hours after exposure

The test compound caused slight lesions of the conjunctivae in all  rabbits. After 24 hours these lesions had subsided completely.

Individual eye irritation scores:
---------------------------------
 
rabbit         cornea          iris             conjunctivae                     Total score
          opacity   area                 redness  chemosis  discharge     
-------------------------------------------------------------------------- -----------------
                                       after 1 hour
  1          0       0           0          1         0         0                    2
  2          0       0           0          1         1         0                    4
  3          0       0           0          1         0         0                    2
  4          0       0           0          1         0         0                    2
  5          0       0           0          1         0         0                    2
  6          0       0           0          1         0         0                    2

                                        after 24 hours
  1          0       0           0          0         0         0                    0
  2          0       0           0          0         0         0                    0
  3          0       0           0          0         0         0                    0
  4          0       0           0          0         0         0                    0
  5          0       0           0          0         0         0                    0
  6          0       0           0          0         0         0                    0

After 48, 72 hours and 7 days all scores were recorded as 0.
-------------------------------------------------------------------------- ------------------

Mean values over 24, 48, and 72 hours for the single animals for cornea,  iris and conjunctivae were without exception zero.  
Thus, the eye irritation score was calculated to be zero.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the available data, the test item is not considered to be eye irritating in rabbits.

Executive summary:

In this in vivo eye irritation study, six healthy adult New Zealand White albino rabbits were used for the test substance. The eyes of the animals were examined before testing and only those animals without observable eye defects are used. 0.1 mL of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid were then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.The other eye remaining untreated, served as a control. The eyes were not washed following instillation.The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material. Eye reactions were evaluated by the method published by Draize and Kelley (1952). After 48, 72 hours and 7 days all scores were recorded as 0. No eye irritation was observed in the study.

Based on the results, the test substance is considered to be not irritating to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

One in vivo study is available on the Laurylacrylate C12C14. The study was performed on rabbit and showed a mild and reversible skin irritation.

Primary irritation to the skin was measured by a patch-test technique on the abraded and intact skin of albino rabbits. Twelve healthy adult New Zealand White albino rabbits were used for the test substance. 24 hours prior to applying the material, the hair was removed from the backs of the animals with an electric clipper in such a way as to avoid  abrasions. The test substance was brought on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. Skin reactions were evaluated by the method of Draize (1944). All erythema and edema scores obtained after 24 and 72 hours (48 scores) were determined.

Mean values over 24 and 72 hours (intact skin) were 1.5 -1.5 -1.0 -1.0 -2.0 -1.5 for erythema score, and 0.5 -0.5 -0.0 -0.5 -1.0 -1.0 for oedema score. Based on the available data, the test item is considered to be slightly irritating in rabbit after 4 hours of exposure (on intact skin).

Eye irritation

One in vivo study is available on the Laurylacrylate C12C14. In this in vivo eye irritation study, six healthy adult New Zealand White albino rabbits were used for the test substance. The eyes of the animals were examined before testing and only those animals without observable eye defects are used. 0.1 mL of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit; the upper and lower eye lid were then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material.The other eye remaining untreated, served as a control. The eyes were not washed following instillation.The eyes were examined at one hour, 24, 48, 72 hours and 7 days after instillation of the test material. Eye reactions were evaluated by the method published by Draize and Kelley (1952). After 48, 72 hours and 7 days all scores were recorded as 0. No eye irritation was observed in the study.

Based on the results, the test substance is considered to be not irritating to the eyes.

Respiratory tract irritation

No specific study is available to evaluate the respiratory tract irritation.

However, an acute study by inhalation is available on laurylacrylate C12C14, and no irritation of the respiratory tract was observed after an exposure of 8hr at the saturated concentration (0.69 mg/l).

Justification for classification or non-classification

Based on the available data, no classification for irritation is required for the reaction mass of C12 -C13 acrylate according to the Regulation EC n°1272/2008.