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Registration Dossier
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EC number: 205-016-3 | CAS number: 131-17-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Date of Study Report: August 9, 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Deviations:
- yes
- Remarks:
- : The test procedure was modified as follows: In Group I, Six rabbits; eyes unwashed following the instillation of the test material. In Group II, Three rabbits; eyes washed 4 seconds following instillation of the test material.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Washout after 4s, no information on a preliminary in vitro study
- GLP compliance:
- no
Test material
- Reference substance name:
- Diallyl phthalate
- EC Number:
- 205-016-3
- EC Name:
- Diallyl phthalate
- Cas Number:
- 131-17-9
- Molecular formula:
- C14H14O4
- IUPAC Name:
- 1,2-bis(prop-2-en-1-yl) benzene-1,2-dicarboxylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Diallyl Phthalate
- Other:
- Identified as No. C8013-3
- Specific gravity: 1.117-1.123 at 20°C/20°C
- Solubility in methanol: 1 cm³ in 5 cm³, clear-only slightly turbid
- Acidity as acetic acid, % by weight: 0.1 max
- Moisture(Karl Fischer): 0.1 max
- Color APHA Pt-Co: 90 max
- Odor: mild
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml or 0.1g - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- All eyes were observed and ocular reaction recorded at 24, 48, and 72 hours after instillation of the test material. They were observed again after 7 days.
- Number of animals or in vitro replicates:
- Group I: 6 rabbits with eyes unwashed following the instillation of the test material
Group II: 3 rabbits with eyes washed for 4 seconds following instillation of the tests material - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent .
- Time after start of exposure: after the 24-hour reading.
SCORING SYSTEM:
TOOL USED TO ASSESS SCORE: Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritant / corrosive response data:
- Group I : Conjunctival effects were observed in four animals. These effects cleared during the 72-hour observation period.
Group II : Conjonctival effects were observed in all three animals. These effects cleared during the 48-hour observation period.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Conclusions:
- On the basis of the data presented herein the following is concluded for the test material, FMC Corporation; D.A.P. (1 Qt. Net Wt.); C-8013-3:
Group I and II: It is a mild transient irritant to the rabbit eye when not followed by or followed by a washout 4 -seconds after instillation of the test material.
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