Dimethyl naphthalene-2,6-dicarboxylate

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Mean of 24, 48 & 72 hrs

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Mean of 24, 48 & 72 hrs

Score:

0

Max. score:

0

Results 3

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

Results 4

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	Mean^a
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	Mean^a
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		Mean^a
		A^b	B^c	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.