Registration Dossier
Registration Dossier
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EC number: 930-890-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Non-GLP study primary dermal irritation study in rabbits, limited information on test material, test system and study design.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Primary dermal irritation study in rabbits, limited information on test material, test system and study design.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (2R)-6-fluoro-2-(oxiran-2-yl)chromane
- EC Number:
- 930-890-4
- Cas Number:
- 1219915-04-4
- Molecular formula:
- C11H11FO2
- IUPAC Name:
- (2R)-6-fluoro-2-(oxiran-2-yl)chromane
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-42398681-AAA (T001589)
- Physical state: liquid
- Appearence: light brown
Constituent 1
- Specific details on test material used for the study:
- no data
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 3 New Zealand White rabbits, no further data on test animals available
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): no data - Duration of treatment / exposure:
- no data
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM:
- Scoring of erythema and eschar formation: no erythema = 0; very slight erythema (barely perceptible) = 1; well-defined erythema = 2; moderate to severe erythema = 3; severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4
- Scoring of edema formation: no edema = 0; very slight edema (edges of area well defined by definite raising) = 1; moderate edema (raise approximately 1 millimeter) = 3; severe edema (raised more than 1 millimeter and extending beyond the area of exposure) = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- T1589 produced no dermal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- For the evaluation of the primary irritation index scores of all rabbits were totaled at 24 h and 72 h giving an index of 0.00 (no dermal irritation).
From these data it is concluded that T001589, when given to New Zealand White rabbits at a single dose of 0.5 ml by dermal application produced no dermal irritation. Based on CLP regulation, the test item is not considered to be classified as skin irritant.
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