Registration Dossier
Registration Dossier
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EC number: 276-957-5 | CAS number: 72869-86-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-06-15 - 1984-06-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliance and according to OECD405
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate
- EC Number:
- 276-957-5
- EC Name:
- 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate
- Cas Number:
- 72869-86-4
- Molecular formula:
- C23H38N2O8
- IUPAC Name:
- 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate
- Details on test material:
- - Name of test material (as cited in study report): Diurethane dimethacrylate
- Physical state: high viscous
- Analytical purity: 100%
- Lot/batch No.: 16/84/399/52a
- Expiration date of the lot/batch: 08/1984
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and were used as the reference control.
- Amount / concentration applied:
- 0.1 ml per animal
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 males,
1 female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #2
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #3
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #2
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #3
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #2
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 13
- Irritation parameter:
- other: cumulative score
- Basis:
- animal #3
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 13
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The tested item PC-Cure P-1001 is not irritating to the eyes.
- Executive summary:
Under the conditions of this experiment, Diurethane Dimethacrylate was found to cause a primary irritation score of 0 when applied to the rabbit eye mucosa. In the area of application no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. No corrosion was obderved at each of the measuring intervals.
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