Octyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Read across from the 2 Ethylhexyl methacrylate category member donor substance.
REPORTING FORMAT FOR THE CATEGORY APPROACH
see attached category document
PM_Lower Alkyl (C1-C8) Methacrylates
The C1-C8 methacrylate esters are slight to mild irritants except for 2-EHMA, which is practically non to slightly irritating.
n-HMA lies between BMA and 2-EHMA of the C1-C8 methacrylate esters. i-BMA and n-BMA are slightly irritating in the rabbit eye and 2-EHMA slightly to none irritating. Thus, it can be assumed that the eye irritating property of n-OMA lies also in the range of 2-EHMA as there are no further indicators for stronger irritation. For precautionary reasons n-OMA has to be regarded as slightly irritating in a worst case approach.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substances Labeling Act Regulations, Section 191.12, Federal Register: 29, 13009 (1964)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octyl methacrylate

EC Number:

218-465-5

EC Name:

Octyl methacrylate

Cas Number:

2157-01-9

Molecular formula:

C12H22O2

IUPAC Name:

octyl 2-methylprop-2-enoate

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Not rinsed

Observation period (in vivo):

24, 48 and 72 hours post dosing

Number of animals or in vitro replicates:

6

Details on study design:

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

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: opthalmoscope and 2.0% fluoroscein sodium solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24+48+72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24+48+72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24+48+72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24+48+72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48h

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008

Conclusions:

Very sligthly irritating

Executive summary:

The ocular irritation that could be induced by 2-ETHYLHEXYL METHACRYLATEwas evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.12, published in the Federal Register (USA) -29 F.R. 13009, 1964.A single application of 0.1 mlof 2-ETHYLHEXYL METHACRYLATE in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours after the instillation. Mean values (24+48+72 h) for ocular irritation were 0.11 for chemosis, 0.33 for enanthema and 0.00 for congestion and opacity. Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as very slightly irritating when administered to the rabbit by ocular route.

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