2-Propenoic acid, 2-methyl-, C6-12-alkyl esters

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:

other: Comparable to guideline study. Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)

Principles of method if other than guideline:

Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decyl methacrylate

EC Number:

221-657-1

EC Name:

Decyl methacrylate

Cas Number:

3179-47-3

Molecular formula:

C14H26O2

IUPAC Name:

decyl 2-methylprop-2-enoate

Details on test material:

- Name of test material (as cited in study report): Decyl methacrylat, roh

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2,4 - 2,6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of each treated animal

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

Any other information on results incl. tables

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

An initial slight irritation of the conjunctiva within the first 8 hours

(irritation scores 0 -2) disappeared entirely within the first 24 h; non-irritating

Classification of eye irritation studies according OECD-GHS-criteria

Substance: Decyl methacrylate, roh                                                     CAS: 3179 -47 -3

Internal No.: UNTER78 -016

Date/Expert: 10 -05 -2012/RG

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: EU

Conclusions:

Classification: not irritating

Executive summary:

In a primary eye irritation study ( according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)) 0.1 mL undiluted Decyl methacrylate, roh was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits, (2.4 -2.6 kg body weight) for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.

In this study Decyl methacrylate, roh is not irritating to eyes.

OECD GHS Category: none

EU GHS Category: none