Isopropyl myristate

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 with acceptable restrictions, Basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

limited documentation

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl myristate

EC Number:

203-751-4

EC Name:

Isopropyl myristate

Cas Number:

110-27-0

Molecular formula:

C17H34O2

IUPAC Name:

isopropyl myristate

Details on test material:

- Name of test material (as cited in study report): isopropyl myristate

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: 1800-2400 g

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye untreated

Amount / concentration applied:

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

Duration of treatment / exposure:

single instillation without washout

Observation period (in vivo):

24h, 48h, 72h, 4 days and 7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE: No

SCORING SYSTEM: according to Draize scale for scoring ocular lesions

TOOL USED TO ASSESS SCORE: hand-held lenses

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: average 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

other: no effects in any animal

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: average 24, 48 and 72h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Remarks on result:

other: no effects in any animal

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: average 24, 48 and 72h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: average 24, 48 and 72h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: average 24, 48 and 72h

Score:

0

Max. score:

3

Reversibility:

other: no effects

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: average 24, 48 and 72h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Any other information on results incl. tables

Individual Scores:

Animal Number	Hours after Application
	24				48				72
	A	B	C	D	A	B	C	D	A	B	C	D
1	0	0	1	0	0	0	0	0	0	0	0	0
2	0	0	1	0	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0	0	0	0	0

A = Cornea Score

B = Iris Score

C = Conjunctiva Score

D = Chemosis Score

After instillation of the test substance into rabbit eyes there was slight conjunctival irritation observed, that was reversible after 48h.

According to DSD and CLP the test substance has not to be classified.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

A primary eye irritation study was conducted equivalent to EU Method B.5 with 3 New Zealand White rabbits. One eye of the rabbits was exposed to 0.1 mL test substance for 24 h and subsequently scored for reactions.

The readings revealed no indications for a eye irritating potential of isopropyl myristate.