Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
april 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test was not conducted according to an OECD Test Guideline. Acceptable data.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
according to ref.: J.H. Kay et col., J.Soc.Cos.Chem. 13/281, 1962
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Ethylhexyl 4-methoxycinnamate
- Physical state: liquid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Group I - 168 hours (not rinsed)
Group II - 2 seconds (rinsed)
Group III - 4 seconds (rinsed)
Observation period (in vivo):
168 hours (at 1, 24, 48, 72, 96 and 168 hours)
Number of animals or in vitro replicates:
Group I - 3
Group II - 3
Group III - 3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group I: not rinsed; Group II: rinsed after 2 sec.; Group III: rinsed after 4 sec.
- Time after start of exposure: 2 sec. and 4 sec.

SCORING SYSTEM: according to ref.: J.H. Kay et col., J.Soc.Cos.Chem. 13/281, 1962

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
3.3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: overall score from all groups
Irritant / corrosive response data:
A slight irritation of the conjunctivae was observed during the few hours after application of pure 2-Ethylhexyl 4-methoxycinnamate. This irritation is manifested by the presence of some more capillaries injected into the eye treated than on the eye not treated. No effect could be detected 24 hours after application of the test substance. No effect of rinsing was observed.

Any other information on results incl. tables

ObservationTime

Animal nr.

Group I

Conjunctivae

Group II

Conjunctivae

Group III

Conjunctivae

Results

1 hour

1

A2

A1

A2

3.3

1 hour

2

A1

A2

A1

 

1 hour

3

A2

A2

A2

 

24 hours

1

 

 

 

0

24 hours

2

 

 

 

24 hours

3

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No effects on eye irritation could be detected 24 hours after application of 2-Ethylhexyl 4-methoxycinnamate. Based on these results, 2-Ethylhexyl 4-methoxycinnamate does not need to be classified as irritating according to the criteria outlined in regulation 1272/2008/EC and 67/548/EEC.
Executive summary:

2-Ethylhexyl 4-methoxycinnamate had been injected into the left eye of 3 albino rabbits without rinsing, the left eye of another 3 albino rabbits were rinsed after 2 and 4 seconds, resp. Cornea, iris, and conjunctivae were examined. A slight irritation of the conjunctivae was observed during the few hours after application of pure 2-Ethylhexyl 4-methoxycinnamate. This irritation is manifested by the presence of some more capillaries injected into the eye treated than on the eye not treated. No effect, however small, could be detected 24 hours after application of the test substance. Based on these results, 2-Ethylhexyl 4-methoxycinnamate does not need to be classified as irritating according to the criteria outlined in regulation 1272/2008/EC and 67/548/EEC.