Registration Dossier
Registration Dossier
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EC number: 695-076-0 | CAS number: 1334513-02-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2012-26 October 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Propan-2-yl N-[(S)-(pentafluorophenoxy)(phenoxy)-phosphoryl]-L-alanine
- EC Number:
- 695-076-0
- Cas Number:
- 1334513-02-8
- Molecular formula:
- C18H17F5NO5P
- IUPAC Name:
- Propan-2-yl N-[(S)-(pentafluorophenoxy)(phenoxy)-phosphoryl]-L-alanine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item
- Name of test material (as cited in study report): GS-606962
- Substance type: organic
- Physical state: white powder
- Lot/batch No.: PSI-172(2)-1-1-12001
- Date received: 09 July 2012
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours after patch removal.
- Number of animals:
- three animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: immediately following patch removal
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour following patch removal
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours following patch removal
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours following patch removal
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours following patch removal
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: immediately following patch removal
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour following patch removal
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hour following patch removal
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours following patch removal
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours following patch removal
- Score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: immediately following patch removal
- Score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1 hour following patch removal
- Score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hour following patch removal
- Score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 48 hours following patch removal
- Score:
- 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hours following patch removal
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:
- OECD Guidelines for the Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 24 April 2002)
- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008
Results.
A single 4 -hour, semi-occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation.
Conclusion.
The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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