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EC number: 271-094-0 | CAS number: 68515-51-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-06-23 to 1988-06-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test substance not described in sufficient details
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters
- EC Number:
- 271-094-0
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters
- Cas Number:
- 68515-51-5
- Molecular formula:
- C20H30O4 - C28H46O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): Witamol 110
- Substance type: product
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: at room temperature in a galss srew-top bottle
- Other: none
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: 2.55 - 3.43 kg
- Housing: single in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers Limited, New Leak, Boston, Lincolnshire, U.K. (ad libitum)
- Water: mains drinking water (ad libitum)
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 18
- Humidity (%): 60 - 75
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1988-06-23 To: 1988-06-27
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye of each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml - Duration of treatment / exposure:
- single administration; unlimited exposure (not rinsed)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- 6 (4 female, 2 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.56
- Conjuntivae (Chemosis): 0.44
- Overall irritation score: 3.9/110 - Other effects:
- DESCRIPTION OF LESIONS: Iridial inflammation was confined to two treated eyes one hour after treatment. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment. The conjunctival irritation regressed and all treated eyes appeared normal 48 to 72 hours after treatment.
Any other information on results incl. tables
Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
1/0/1/0/0/0 |
2/1/2/1/2/2 |
1/1/1/1/1/1 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/2/1/2/1 |
0/1/2/0/2/1 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/1/0/1/0 |
0/0/1/0/1/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0.56 |
0.44 |
Area effected |
|
|
||
Maximum average score (including area affected, max 110) |
|
|
|
|
Reversibility*) |
- |
- |
c. |
c. |
Average time (unit) for reversion |
- |
- |
72 hours |
72 hours |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters was only slightly eye irritating.
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