Registration Dossier
Registration Dossier
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EC number: 268-581-5 | CAS number: 68130-24-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- December 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- - Principle of test:
Draize test
- Short description of test conditions: 6 Nex Zealand white rabbits, free from ocuar defects, each received a single intraocular application of 0.1 mL of the test article in one eye. The contralateral eye, remaining untreated, served as control. the eyes of animal remained unwashed for 24 hours.
- Parameters analysed / observed: Corneal opacity, iritis and conjunctivitis recorded at 24, 48 and 72 hours after treatment, and at 4 and 7 days if irritation persisted. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
- EC Number:
- 268-581-5
- EC Name:
- Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
- Cas Number:
- 68130-24-5
- Molecular formula:
- C10-H22-O7.x-C10-H20-O2.x-C8-H16-O2.x-C5-H10-O2
- IUPAC Name:
- Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
- Test material form:
- liquid
- Details on test material:
- - Moisture content:<= 0.05 %
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: P-612J4
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- 6 New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 mL of the test article in one eye. The contralateral eye, remaining untreated, served as control.
The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iriitis and conjunctivitis were recorded 24,48 and 72 hours after treatment, and at 4 and 7 days if irritation persisted.
The test article was used as a 10% gravimetric corn oil suspension.
Test system
- Vehicle:
- other: corn oil
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% in corn oil
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 New Zealand white rabbits,
- Details on study design:
- 6 New Zealand white rabbits, free from visible ocular defects, each received a single intraocular application of 0.1 mL of the test article in one eye. The contralateral eye, remaining untreated, served as control.
The eyes of all animals remained unwashed for 24 hours. Observations of corneal opacity, iriitis and conjunctivitis were recorded 24,48 and 72 hours after treatment, and at 4 and 7 days if irritation persisted.
The test article was used as a 10% gravimetric corn oil suspension.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Draize Score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Draize Score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Conclusions:
- This test article is not an ocular irritant to rabbits under conditions of this test.
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