Registration Dossier
Registration Dossier
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EC number: 701-374-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- EC Number:
- 701-374-4
- Cas Number:
- 25550-98-5
- Molecular formula:
- C26H47O3P
- IUPAC Name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- Reference substance name:
- Phenyldiisodecyl Phosphite
- IUPAC Name:
- Phenyldiisodecyl Phosphite
- Details on test material:
- - Name of test material (as cited in study report): Phenyldiisodecyl Phosphite
- Substance type:
- Physical state: Liquid
- Lot/batch No.: PDDP-002-03240A, Borg-Warner
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- Six healthy young adult albino rabbits were used in this study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eyes of each rabbit not treated with test materials
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Seven days total exposure
- Observation period (in vivo):
- Treated eyes (right eyes) examined at 1, 2, 3, 5 and 7 days following the instillation of the test materials
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not removed
- Time after start of exposure: N/A
SCORING SYSTEM: Draize Scale of Scoring Ocular Lesions
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 day
- Score:
- 3.3
- Max. score:
- 6
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 2 day
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 day
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 5 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 day
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Based on the data, the subject material is not a primary occular irritant within the definition of the Act-Reference: Section 1500:42 (b)(1)(2) and requires no cautionary labeling with respect to that section.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The subject material is not a primary occular irritant within the definition of the Act-Reference: Section 1500.42(b)(1)(2).
- Executive summary:
0.1mL of phenyldiisodecyl phosphite were instilled into the right eyes of six healthy young adult albino rabbits, while the left eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1, 2, 3, 5 and 7 days following the instillation of the material and evaluated in accordance with the Draize Scale of Scoring Ocular Lessions. The average ocular irritation score was 3.3, 2.3, 0.7, 0.0, and 0.0 after 1, 2, 3, 5 and 7 days, respectively. Based on these results, the subject material is not considered a primary occular irritant within the definition fo the Act-Reference: Section 1500.42(b)(1)(2).
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