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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 September to 05 September 1986.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Ethyl 2-methylpentanoate
Cas Number:
39255-32-8
IUPAC Name:
Ethyl 2-methylpentanoate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Manzanate, DL 4979/F4-24.
- Physical state: clear, colourless, slightly viscous liquid
- Other:
- A sample of the test material was received from the sponsor on August 14, 1986.

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand White albino rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: obtained from ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: body weight range 2500-3500 g
- Housing: The animals were identified by earmarking, and housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front.
- Diet (e.g. ad libitum): A standard laboratory rabbit diet was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): at least 40% (relative humidity)
- Air changes (per hr): ventilation c. 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Experimental design:
- Both eyes of each rabbit provisionally selected were examined within 24 hours before testing. Three animals without observable eye effects were used.
- One tenth of a millilitre of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit. After administration the upper and lower eye lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The eyes were not washed out following administration and the animals were released immediately.
- Ocular reactions were judged using the scoring scale which is given in an appendix at the end of this report (see page 10 of attached report).
- Eye effects were examined after one hour, 24, 48 and 72 hours, or until the eye effects had cleared completely.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 4020
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: 4022
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: 4023
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 4020
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 4022
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 4023
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 4020
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal: 4022
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal: 4023
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 4020
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 4022
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 4023
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

- After one hour and after 24 hours, the eye effects observed in all (three) rabbits consisted of slight redness and slight swelling of the conjunctivae.

- After 48 hours, all eye effect had cleared completely.

Table 1. Individual Scores Awarded to the Ocular Lesions Elicited by Manzanate

Rabbit number

Cornea opacity

Iris

Conjunctivae

Redness

Chemosis

 

 

 

After one hour

4020

0

0

1

1

4022

0

0

1

1

4023

0

0

1

1

 

 

 

After 24 hours

4020

0

0

1

1

4022

0

0

1

1

4023

0

0

1

1

 

 

 

After 48 hours

4020

0

0

0

0

4022

0

0

0

0

4023

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the results obtained it is concluded that, according to the EEC-standards (as published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1984), the undiluted test substance Manzanate is not irritating or corrosive to eyes.
Executive summary:

1. A sample of Manzanate was examined undiluted for acute eye irritating/corrosive properties in an experiment with three albino rabbits.

2. The test substance caused slight eye effects in all (three) rabbits. After 48 hours, all eye effects had cleared completely.

3. On the basis of the results obtained it was concluded that, according to the EEC-standards, the undiluted test substance Manzanate is not irritating or corrosive to eyes.

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