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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
1998

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

Constituent 1
Chemical structure
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

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