Registration Dossier
Registration Dossier
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EC number: 943-540-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 May 1982 to 10 May 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to recognised test guideline.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.02 Federal Hazardous Substances Act Regulations CFR 16 P.125
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl
- EC Number:
- 943-540-0
- Molecular formula:
- Too complex
- IUPAC Name:
- Reaction Products of Diphosphorus Pentaoxide with Alcohols, C14-18 even, salted with Amines, C12-14, Tert-alkyl
- Test material form:
- not specified
- Details on test material:
- - Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Stainless steel caging with elevated wire mesh flooring
- Diet (e.g. ad libitum): wayne 15% Rabbit Ration ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 +/- 5%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 03 May 1982 To: 10 may 1982
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye served as a control for each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml into the right eye per animal - Duration of treatment / exposure:
- The test material was not washed from the eye.
- Observation period (in vivo):
- 1, 2, 3, 4, and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize scale of scoring ocular lesions
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation scores greater than zero were recorded for any tissue of any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not an irritant to the eye of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008.
- Executive summary:
Test Guidance
In a study conducted according to Section 1500.02 Federal Hazardous Substances Act Regulations CFR 16 P.125 the test chemical was placed into the right eye of each of 6 New Zealand White rabbits. The untreated eye acted as a control. The eyes were not washed after instillation. Treated eyes were examined at 1, 2, 3, 4 and 7 days after instillation.
Results
No irritation score greater than zero was recorded for any tissue of any of the six animals at any of the observation time-points.
Conclusion
The test material is not an irritant to the eye of rabbits. The test material is not classified in accordance with Regulation (EC) No. 1272/2008.
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