Hexadecyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

20-06-1989 - 28-06-1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study OECD 401, GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

EC Number:

288-509-6

EC Name:

2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich

Cas Number:

85736-97-6

IUPAC Name:

85736-97-6

Constituent 2

Reference substance name:

Isotridecyl methacrylate

EC Number:

304-180-4

EC Name:

Isotridecyl methacrylate

IUPAC Name:

Isotridecyl methacrylate

Test material form:

other: liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: Lippische Versuchstieranstalt Hagemann GmbH & Co. KG, Extertal, Germany
Age at study initiation: 10 w


The animals were housed individually. Conventional laboratory diet (mümmel z, ssniff / Soest) and an unrestricted supply of drinking water
were available. The temperature of the experimental animal room was 18 °C (±2 °C) and the relative humidity 40 to 50 %.
Lighting sequence: 12 hrs light, 12 hrs darkness
Condition time: 7 days

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

The eyes were not washed out following the instillation

Observation period (in vivo):

1, 24, 48 and 72 hours as well as 8 days 

Number of animals or in vitro replicates:

3

Details on study design:

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

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: ophthalmoscope and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

other: mean 24 + 48 + 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

other: mean 24 + 48 + 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

other: mean 24 + 48 + 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

other: mean 24 + 48 + 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after dosing, one animal exhibited slight conjunctival redness and slight discharge, a second animal slight discharge only.
At 24 hrs following dosing, all signs of irritation had resolved.
The remaining animal showed no signs of irritation at any time during the test.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: other: CLP, EU, GHS (Regulation (EC) No 1272/2008)

Conclusions:

In an OECD 405 eye irritation study Isotridecyl methacrylate showed no signs of irritation. Therefore the substance has not to be classified acc. CLP
criteria.

Executive summary:

In an OECD 405 guideline study, with GLP, Isotridecyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits. The lids were then gently held together for one second. The test eyes were not washed out following the instillation. The left eye remained untreated for control. The eyes were examined at 1, 24, 48 and 72 hours as well as 8 days from beginning of test. Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis, discharge). Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. One hour after dosing, one animals exhibited slight conjunctival redness and slight discharge. A second animal exhibited slight discharge one hour after dosing. At 24 hours following dosing all signs of irritation had resolved. The remaining third animal showed no signs of irritation at any time during the test. Isotridecyl methacrylate is considered as non-irritating to eyes.

The results demonstrate that Isotridecyl methacrylate (CAS 85736-97-6) is not an eye irritant.

Therefore the test substance has not to be classified - according CLP criteria.

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.