Registration Dossier
Registration Dossier
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EC number: 629-664-5 | CAS number: 79710-86-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-10-28 until 1997-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- oxolane-3-carbaldehyde
- EC Number:
- 629-664-5
- Cas Number:
- 79710-86-4
- Molecular formula:
- C5 H8 O2
- IUPAC Name:
- oxolane-3-carbaldehyde
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Hra:(NZW)SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc. (Denver, PA)
- Age at study initiation: young adult (at least three month old')
- Weight at study initiation: at least 200 g grams at the start of the study
- Housing: singly, in suspended, stainless-steel mesh cages. Cages and racks were washed once a week.
- Diet: Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum
- Water: municipal drinking water, regularly assayed
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18-21°C
- Humidity: 53-54 %
- Photoperiod: 12 hours of artificial light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: test item as such (no vehicle) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx 6 cm2
- Type of wrap if used: fiber pad and an occlusive wrap
REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with running water
SCORING SYSTEM: OECD Draize - as described in OECD Guideline 405 (Annex V., Test B.4) (Grading of Skin Reaction)
- Body weights were measured on the day of initiation of the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 -48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 -48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 -48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 -48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 -48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No irritant response noted
Any other information on results incl. tables
Exposition: |
4 h |
|||
Animal |
Reading |
Erythema |
Edema |
|
1 |
1 h |
0 |
0 |
|
2 |
1 h |
0 |
0 |
|
3 |
1 h |
0 |
0 |
|
1 |
24 h |
0 |
0 |
|
2 |
24 h |
0 |
0 |
|
3 |
24 h |
0 |
0 |
|
1 |
48 h |
0 |
0 |
|
2 |
48 h |
0 |
0 |
|
3 |
48 h |
0 |
0 |
|
1 |
72 h |
0 |
0 |
|
2 |
72 h |
0 |
0 |
|
3 |
72 h |
0 |
0 |
|
mean |
24 - 72 h |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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