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EC number: 271-089-3 | CAS number: 68515-47-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Principles of method if other than guideline:
- A dose of 0.1 ml of test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were held together for one second prior to releasing to prevent loss of material. The contralateral eye served as the control.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich
- EC Number:
- 271-089-3
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich
- Cas Number:
- 68515-47-9
- Molecular formula:
- C34H58O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich diisotridecyl Phthalate
- Details on test material:
- Test material was suppplied as a clear liquid.
- Name of test material (as cited in study report): MRD-81-20
- Physical state: clear liquid
- Other: specific gravity 0.954
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Number - 6
- Source: Dutchland Laboratories, Inc.
- Age at study initiation: young adults
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): monitored daily
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): used as supplied - Observation period (in vivo):
- 1, 4, 24, 48 and 72 hours and 4 and 7 days after treatment.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- DETAILS
- Material was introduced into the lower conjunctival sac of the right eye of each animal.
- The upper and lower lids were held together for one second prior to releasing to prevent loss of material.
- The contralateral eye served as the control.
SCORING SYSTEM:
- Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Average 24, 48 and 72 hours
- Score:
- 0.44
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Average 24, 48 and 72 hours
- Score:
- 0.22
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Average 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: No effects noted
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Average 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: No effects noted
- Irritant / corrosive response data:
- Most animals exhibited positive scores for ocular irritation at 1 and 4 hours post exposure. All animals were free of signs of ocular irritation within 48 or 72 hours post instillation of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on observation made at 24, 48, and 72 hours post exposure, this substance is not considered an eye irritant.
- Executive summary:
In this study, rabbits were exposed to DTDP to assess eye irritation. A dose of 0.1 ml of test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were held together for one second prior to releasing to prevent loss of material. Assessment of eye irritation occurred at 1, 4, 24, 48 and 72 hours post exposure. Most animals had slight ocular irritation at 1 and 4 hours post exposure. None of the animals exhibited positive scores for ocular irritation at 24 hours, and all animals were free of signs of ocular irritation within 48 or 72 hours post instillation.
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