Isodecyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

OSHA Toxicity Screening Test. Limited documentation of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OSHA Toxicity Screening Test

Principles of method if other than guideline:

Draize

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isodecyl methacrylate

EC Number:

249-978-2

EC Name:

Isodecyl methacrylate

Cas Number:

29964-84-9

Molecular formula:

C14H26O2

IUPAC Name:

2-methylnonyl 2-methylprop-2-enoate

Details on test material:

2-Propenoic acid, 2-methyl-, isodecyl ester purity not specified, but commercial grade assumed.

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

72 hours, unrinsed

Observation period (in vivo):

7 days after treatment

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48, 72 hr

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: not rinsed

Results 2

Irritation parameter:

other: index of primary eye irritation

Basis:

mean

Time point:

other: 24, 48, 72 hr

Score:

0

Max. score:

13

Reversibility:

fully reversible

Remarks on result:

other: re-evaluated according to OECD405

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 9

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 10

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 12

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 13

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 14

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 18

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 20

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 21

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 22

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 23

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 24

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 25

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 26

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

Index of primary eye irritation: 0.0 of 13 (re-evaluated according to OECD 405)

An initial irritation of the conjunctiva within the first hour

(irritation score 2.3) disappeared entirely within the first 24 h; non-irritating

Classification of eye irritation studies according OECD-GHS-criteria

Substance: Isodecyl methacrylate                                                    CAS: 29964 -84 -9

Date/Expert: 06 -12 -12 / Mls

Animal No.	Corneal opacity/Hornhauttrübung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1, 2	0 0	0 0	0 0	0 0	0 0	-
3, 4	0 0	0 0	0 0	0 0	0 0	-
5, 6	0 0	0 0	0 0	0 0	0 0	-
							none
Animal No.	Iritis/Regenbogenhautentzündung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1, 2	0  0	0  0	0 0	0 0	0 0	-
3, 4	0 0	0 0	0 0	0 0	0 0	-
5, 6	0 0	0 0	0 0	0 0	0 0	-
							none
Animal No.	Conjunctiva redness (erythem) /Bindehautrötung[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1, 2	0 0	0 0	0 0	0 0	0 0	-
3, 4	0 0	0 0	0 0	0 0	0 0	-
5, 6	0 0	0 0	0 0	0 0	0 0	-
							none

Animal No.	Conjunctiva chemosis /Bindehautödem[Scores]			Mean Draize score	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1, 2	0 0	0 0	0 0	0 0	0 0	-
3, 4	0 0	0 0	0 0	0 0	0 0	-
5, 6	0 0	0 0	0 0	0 0	0 0	-
							none

Classification: Hazard Category

none

Classification Criteria for serious Eye Damage/Eye

Category 1

- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal

- Mean Draize score in 2 of 3 canimals:

corneal opacity≥3

iritis≥ 1,5

Category 2

- Reversible adverse effects on cornea, iris, conjunctiva

- Mean Draize score in 2 of 3 animals:

corneal opacity >= 1

iritis >=1

redness >= 2

chemosis >= 2

Subcategory 2A

- Reversible in 21 days

Subcategory 2B

- Reversible in 7 days

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Classification: not irritating

Executive summary:

In a primary eye irritation study (OSHA Toxicity Screening Test, according to Draize) 0.1 mL undiluted Isodecyl methacrylate was was applied to 6 Albino rabbits. Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.

In this study Isodecyl methacrylate is not irritating to eyes.

EU GHS / CLP Category: none

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.