Reaction mass of dodecyl methacrylate and tridecyl methacrylate

Eye irritation

Administrative data

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:

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:

Draize eye test

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2311-2720 g

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

eyes were not rinsed

Observation period (in vivo):

4 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scale; a modified form of the system described by Kay and Calandra (1962) was used to interpret and classify the numerical scores

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1-3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1-3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1-3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #2, 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	0/0/0	0/0/0	1/1/1	1/0/0
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	0/0/0	0/0/0	0.33/0.33/0.33	0.33/0/0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Reaction mass of dodecyl methacrylate and tridecyl methacrylate is not irritating to the eyes in this study.

Executive summary:

In a primary eye irritation study 0.1 mL of Reaction mass of dodecyl methacrylate and tridecyl methacrylate was instilled into the conjunctival sac of the left eye of 3 female young adult New Zealand White rabbits. The eyes were not rinsed afterwards. The animals then were observed for 3 days.  Irritation was scored by the method of Draize.

Instillation into the rabbit eye caused no initial pain (class 0 on a 0-5 scale). Conjunctival effects were observed in all three rabbits and consisted of slight redness, slight chemosis and moderate or severe discharge. There were no corneal or iridial effects. All signs of irritation had disappeared two days after instillation.

As a result of these effects, Reaction mass of dodecyl methacrylate and tridecyl methacrylate is not classified as eye irritant.

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