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Toxicological information

Eye irritation

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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

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

Resultsopen allclose all
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
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
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
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.

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