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EC number: 212-661-4 | CAS number: 840-65-3
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:
- 1 991
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
- 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
Constituent 1
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.
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