Reaction mass of dodecyl methacrylate and tridecyl methacrylate

Skin irritation / corrosion

Administrative data

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Principles of method if other than guideline:

According to Draize J H (1959). Appraisal of the safety of chemicals in foods, drugs and cosmetics. Association of Food and Drug Officials of the US, 49.

A single four-hour application was made to the left flank and a total of three four-hour applications, on consecutive days, was made to the right flank.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tridecyl methacrylate

EC Number:

219-671-8

EC Name:

Tridecyl methacrylate

Cas Number:

2495-25-2

Molecular formula:

C17H32O2

IUPAC Name:

tridecyl methacrylate

Constituent 2

Reference substance name:

Dodecyl methacrylate

EC Number:

205-570-6

EC Name:

Dodecyl methacrylate

Cas Number:

142-90-5

Molecular formula:

C16H30O2

IUPAC Name:

dodecyl methacrylate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2404-2879 g

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

3 d

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: shorn dorso-lumbar region, 2.5 cm²
single applications (left flank)
repeated applications (right flank): The repeated-application sites were assessed approximately 30-60 minutes after the removal of the dressings following each application and 1, 2, 3, 7, 9 and 14 days after removal of the dressings following the final application.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): On removal of the dressings, the skins were cleansed with clean warm water.

OBSERVATION TIME POINTS
30-60 min, 1, 2, 3 days

SCORING SYSTEM:
- Method of calculation: Draize scale (Draize 1959),

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: #2-6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

animal: #1-6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Single Application: Very slight or moderate to severe erythema was observed in five rabbits 30-60 minutes after decontamination. Very slight erythema was observed in one rabbit one day after decontamination. All
signs of erythema had disappeared two days after decontamination. Very slight or slight oedema was observed in four rabbits 30-60 minutes after decontamination. All signs of oedema had disappeared one day after
decontamination.

Repeated Applications: Repeated (x3) four-hour applications of the undiluted test sample to rabbit skin caused moderate to severe erythema in all six rabbits during the application phase and one, two and three days after decontamination of the final application. All signs of erythema had disappeared seven days after decontamination of the final application. Slight to severe oedema was observed in all six rabbits during the application phase and one day after decontamination of the final application. Slight to severe oedema was observed in four rabbits two days after decontamination of the final application; one rabbit had thickening obscuring any oedema. Moderate or severe oedema was still observed in three rabbits three days after decontamination of the final application.
All signs of oedema had disappeared seven days after decontamination of the final application.
Additional signs of irritation were desquamation, thickening and hardening.

Other effects:

One animal was killed during the study but its illness was not thought to be compound-related.

Any other information on results incl. tables

Single exposure

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	3/1/0/1/1/1	1/0/0/2/1/2
24 h	1//00/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0.3/0/0/0/0/0	0/0/0/0/0/0
Reversibility	Completely reversible within 48 h	Not applicable

 

Repeated exposures (3)

Animal number	Erythema			Edema
	Number of applications			Number of applications
	1	1	2	1	2	3
1	2	2	4	0	1	2
2	1	1	2	0	0	2
3	0	1	3	0	1	3
4	2	2	4	2	4	4
5	1	2	4	1	1	4
6	1	3	4	2	2	4

 

Animal number	Erythema						Edema
	Days after final application						Days after final application
	1	2	3	7	9	14	1	2	3	7	9	14
1	4	4	2	-	-	-	2	2	0	-	-	-
2	3	2	2	0	0	0	2	2	0	0	0	0
3	2	2	3	0	0	0	3	3	3	0	0	0
4	4	4	4	0	0	0	4	4	4	0	0	0
5	4	4	2	0	0	0	2	0	0	0	0	0
6	4	4	3	0	0	0	4	?	3	0	0	0

- animal killed, therefore, no observation made

? thickening obscuring possible oedema

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Reaction mass of dodecyl methacrylate and tridecyl methacrylate was not irritating to skin in this study.

Executive summary:

In a primary dermal irritation study 6 female young adult New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted Reaction mass of dodecyl methacrylate and tridecyl methacrylate for 4 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize.

Very slight or moderate to severe erythema was observed in five rabbits 30-60 minutes after decontamination. Very slight erythema was observed in one rabbit one day after decontamination. All signs of erythema had disappeared two days after decontamination. Very slight or slight oedema was observed in four rabbits 30-60 minutes after decontamination. All signs of oedema had disappeared one day after decontamination.

Additionally, the substance was applied in three repeated 4 hours exposures. Repeated (x3) four-hour applications of the undiluted test sample to rabbit skin caused moderate to severe erythema in all six rabbits during the application phase and one, two and three days after decontamination of the final application. All signs of erythema had disappeared seven days after decontamination of the final application. Slight to severe oedema was observed in all six rabbits during the application phase and one day after decontamination of the final application. Slight to severe oedema was observed in four rabbits two days after decontamination of the final application; one rabbit had thickening obscuring any oedema. Moderate or severe oedema was still observed in three rabbits three days after decontamination of the final application. All signs of oedema had disappeared seven days after decontamination of the final application. Additional signs of irritation were desquamation, thickening and hardening.

Reaction mass of dodecyl methacrylate and tridecyl methacrylate is not classified as skin irritant based on the results of this study according to the GHS criteria.

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