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EC number: 203-288-8 | CAS number: 105-34-0
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: Scientifically acceptable data based on a GLP guideline study, reported as secondary quotation in an acknowledged review on eye irritation data published by the ECETOC.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- The ECETOC has published a series of rabbit eye irritation data referring to 132 chemicals and 149 in vivo eye irritation studies. Particular attention was given to purity data of the chemicals, and all studies considered were OECD guideline studies conducted under GLP conditions.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl cyanoacetate
- EC Number:
- 203-288-8
- EC Name:
- Methyl cyanoacetate
- Cas Number:
- 105-34-0
- Molecular formula:
- C4H5NO2
- IUPAC Name:
- methyl 2-cyanoacetate
- Details on test material:
- - Name of test material (as cited in study report): Methyl cyanoacetate
- Physical state: liquid
- Analytical purity: 99 %
- Supplier: Sigma Aldrich, Product No.: 10,842-1
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- - Amount(s) applied: 0.1 mL
- Concentration: 100 % - Duration of treatment / exposure:
- it was not specified whether the eye was rinsed or not after treatment.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- READING TIME POINTS
- after 1 hour, 1, 2, 3, 7 and 14 days
SCORING SYSTEM
- According to Draize et al. (J Pharmacol Exp Ther 82: 377-390, 1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: no corneal opacity was seen at time point 1 hour.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: at none of the reading time points corneal opacity was seen.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: corneal opacity graded 1 was only seen at day 1.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: no effects in the iris were seen at time point 1 hour.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: no effects in the iris were seen at time point 1 hour.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: no effects in the iris were seen at time point 1 hour.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Conjunctival redness graded 2 was seen at time point 1 hour.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: conjunctival redness graded 2 was reported at time point 1 hour and also at day 7.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: conjunctival redness graded 2 was reported at time point 1 hour.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: chemosis graded 2 was seen at time point 1 hour.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: chemosis graded 2 was seen at time point 1 hour.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48, 72 hrs
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: chemosis graded 2 was seen at time point 1 hour.
- Irritant / corrosive response data:
- Signs of irritation were seen in all 3 tested animals and almost were reversible within 7 days following treatment. Whereas corneal opacity and iritis did not exceed a mean scoring value of 1, respectively, conjunctival redness reached a mean score of 3 for each animal, regarding the relevant reading time points of 24, 48 and 72 h. The mean scores for chemosis were 2.67, 2.33 and 1.33, for each animal respectively. Thus, according to current evaluation criteria, methyl cyanoacetate is irritating to the eye of rabbit.
- Other effects:
- Discharge graded 1 was reported for all 3 animals at 24, 48 and 72 h. In 2 cases, discharge already was seen at time point 1 hour, and was graded 1 and 2, respectively. The finding was fully reversible in all animals at day 7.
Any other information on results incl. tables
Table 1: Eye irritation scores:
Observation time |
Rabbit no. |
||||||||||||
1 |
2 |
3 |
|||||||||||
cornea |
iris |
conjunctiva |
chemosis |
cornea |
iris |
conjunctiva |
chemosis |
cornea |
iris |
conjunctiva |
chemosis |
||
1h |
0 |
0 |
2 |
2 |
0 |
0 |
2 |
2 |
0 |
0 |
2 |
2 |
|
24 h |
1 |
1 |
3 |
3 |
0 |
1 |
3 |
2 |
1 |
1 |
3 |
2 |
|
48 h |
1 |
1 |
3 |
3 |
0 |
1 |
3 |
3 |
0 |
1 |
3 |
1 |
|
72 h |
1 |
1 |
3 |
2 |
0 |
1 |
3 |
2 |
0 |
1 |
3 |
1 |
|
7 d |
0 |
0 |
2 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
|
14 d |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean value 24 + 48 + 72 h |
1.00 |
1.00 |
3.00 |
2.67 |
0.00 |
1.00 |
3.00 |
2.33 |
0.33 |
1.00 |
3.00 |
1.33 |
|
Mean value 24 + 48 + 72 h all animals |
0.44 |
1.00 |
3.00 |
2.11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
lowest value for 2 of 3 animals |
0.33 |
1.00 |
3.00 |
2.33 |
|
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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