Registration Dossier
Registration Dossier
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EC number: 275-164-1 | CAS number: 71076-48-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
- Principles of method if other than guideline:
- 0.5 mL of the test substance was applied for 4 hours to the abraded and intact skin of 6 rabbits. Reading was performed upon removal of test substance and 24 and 48 h after initial application.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Oleic acid
- EC Number:
- 204-007-1
- EC Name:
- Oleic acid
- Cas Number:
- 112-80-1
- Molecular formula:
- C18H34O2
- IUPAC Name:
- octadec-9-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Emersol 213
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino rabbit, not further specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped as well as clipped and abraded test sites
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 44 hours
Reading time points: upon removal of patches, 20 and 44 hours after patch removal (correspondingly to 24 and 48 h after initial application) - Number of animals:
- 6 animals, each with 4 test sites (1. control, intact, 2. control, abraded, 3. test material, intact, 4. test material, abraded)
- Details on study design:
- TEST SITE
- Type of wrap if used: The gauze patches (1.5 inch x 1.5 inch) were secured to the area by thin bands of adhesive tape. The entire trunks of the animals were then wrapped in clear plastic trunk bands.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): following the initial reading, all test sites were washed with appropriate solvent
- Time after start of exposure: ca. 4 hours
SCORING SYSTEM:
A: Erythema and eschar formation
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
B: Edema Formation
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (area raised approx. 1 mm): 3
Severe edema (raised more than 1 mm, and extending beyond area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals (intact sites)
- Time point:
- other: mean over 20 h and 44 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: intact site
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals (intact sites)
- Time point:
- other: mean over 20 h and 44 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: intact site
- Irritant / corrosive response data:
- After 4 hour exposure to the test substance all rabbits showed slight erythema-eschar (score 1) without a difference between intact and abraded skin. Following this initial reading, the test substance was washed up.
24 hours after initial application no erythema-eschar (score 1) were observed except at one abraded area of one of the six rabbits. The mean score after 48 hours after initial application was 0 for intact and abraded skin, respectively.
No edema were observed up to 48 hours after initial application.
Any other information on results incl. tables
Abraded skin sites were not taken into account for assessment.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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