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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:
November 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented and scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
NDC was placed in the right eye of each of three rabbits at a dose of 0.1 g, with the left eye serving as an untreated control. The treated eye of each rabbit was scored for irritation at 1, 24, 48, and 72 hours following test article application. The control eye was used for comparison.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl naphthalene-2,6-dicarboxylate
EC Number:
212-661-4
EC Name:
Dimethyl naphthalene-2,6-dicarboxylate
Cas Number:
840-65-3
Molecular formula:
C14H12O4
IUPAC Name:
2,6-dimethyl naphthalene-2,6-dicarboxylate
Test material form:
solid: flakes
Details on test material:
CAS number: 840-65-3

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-4 months of age
- Weight at study initiation: approximately 2.0-3.5 kg
- Housing: Each rabbit will be housed individually in a stainless steel cage (45.5 x 41 x 61 cm) suspended over excrement pans.
- Diet (e.g. ad libitum): Approximately 150 g of Purina Lab Rabbit Chow HF #5326 will be provided daily for each rabbit.
- Water (e.g. ad libitum): Water purified by reverse osmosis will be provided ad libitum by means of an automatic watering system.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature will be regulated to avoid extreme fluctuations.
- Humidity (%): Humidity will be regulated to avoid extreme fluctuations.
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle

No additional data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
at a dose of 0.1 g
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:
SCORING SYSTEM: DRAIZE

No additional data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 & 72 hrs
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The maximum eye irritation score of 6.7/110.0 was obtained 1 hour after application of Dimethyl-2,6-Naphthalene Dicarboxylate (DM-2,6-NDC).

Any other information on results incl. tables

Cornea (Density of Opacity)

Animal Number

Sex

Scoring Interval

1 hr

24 hr

48 hr

72 hr

Meana

626

627

628

M

F

F

0

0

0

0

0

0

0

0

0

0

0

0

0.0

0.0

0.0

Iris

Animal Number

Sex

Scoring Interval

1 hr

24 hr

48 hr

72 hr

Meana

626

627

628

M

F

F

0

0

0

0

0

0

0

0

0

0

0

0

0.0

0.0

0.0

Conjunctiva

Animal Number

Sex

Scoring Interval

1 hr

24 hr

48 hr

72 hr

Meana

Ab

Bc

A

B

A

B

A

B

A

B

626

627

628

M

F

F

1

1

2

1

0

2

0

0

2

0

0

1

0

0

1

0

0

0

0

0

0

0

0

0

0.0

0.0

1.0

0.0

0.0

0.3

aExcludes the 1-hr scores, as per the EEC criteria.

bA = Erythema

cB = Chemosis

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
NDC was found to be a non-irritant to the eyes.