Registration Dossier
Registration Dossier
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EC number: 629-661-9 | CAS number: 83834-59-7
Eye irritation
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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- 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 substance name:
- 2-ethylhexyl 4-methoxycinnamate
- EC Number:
- 226-775-7
- EC Name:
- 2-ethylhexyl 4-methoxycinnamate
- Cas Number:
- 83834-59-7
- Molecular formula:
- C18H26O3
- IUPAC Name:
- 2-Propenoic acid, 3-(4-methoxyphenyl)-, 2-ethylhexyl ester, (2E)-
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethylhexyl 4-methoxycinnamate
- Physical state: liquid
- Analytical purity: no data
Constituent 1
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: 0.1 mL
- Concentration: 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 with water after 2 sec.; Group III: rinsed with water 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
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: overall score from all groups
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: overall score from all groups
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 1 hour
- Score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 2 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 2 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 2 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #7
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 4 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #8
- Time point:
- other: 1 hour
- Score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 4 sec.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #9
- Time point:
- other: 1 hour
- Score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: rinsed after 4 sec.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: overall score from all groups
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: Overall score from all groups
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- 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.
No effects on cornea and iris were 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:
- GHS criteria not met
- 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.
- 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.
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