Registration Dossier
Registration Dossier
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EC number: 419-600-2 | CAS number: 99199-90-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (+/-)-[(R*,R*)and(R*,S*)]-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran
- EC Number:
- 419-600-2
- EC Name:
- (+/-)-[(R*,R*)and(R*,S*)]-6-fluoro-3,4-dihydro-2-oxiranyl-2H-1-benzopyran
- Cas Number:
- 99199-90-3
- Molecular formula:
- C11H11FO2
- IUPAC Name:
- (2R)-6-fluoro-2-[(2R)-oxiran-2-yl]-3,4-dihydro-2H-1-benzopyran; (2R)-6-fluoro-2-[(2S)-oxiran-2-yl]-3,4-dihydro-2H-1-benzopyran; (2S)-6-fluoro-2-[(2R)-oxiran-2-yl]-3,4-dihydro-2H-1-benzopyran; (2S)-6-fluoro-2-[(2S)-oxiran-2-yl]-3,4-dihydro-2H-1-benzopyran
- Details on test material:
- - Name of test material (as cited in study report): NEB654 COND
- Physical state: colourless liquid
- Lot/batch No.: A13 04 A0022
- Expiration date of the lot/batch: December 2013
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- 3 female albino New Zealand rabbits
weight 2.16 - 3.04 kg
11 weekd old
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Dose of 0.5 ml
- Duration of treatment / exposure:
- 4 hrs
- Number of animals:
- 3
- Details on study design:
- The untreated opposite flank of the animal was served as the control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 1.667
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 and 14
- Remarks on result:
- other: slight to well defined
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: days 3 and 7
- Remarks on result:
- other: slight edema
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hrs
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hrs
- Score:
- 1.667
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0.667
- Max. score:
- 1
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained enable to conclude that the test item must be classified "irritating to skin, according Dir. 67/548, 2001/59 and 99/45.
In accordance with the Reg. no. 1272/2008/EC the test item must not be classified.
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