Registration Dossier
Registration Dossier
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EC number: 701-459-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non-GLP, occlusive coverage, no washing after 24 h exposure
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- Before OECD Guideline 404 was established in 1982, skin irritation was tested according to the acknowledged Draize test method.
An amount of 0.5 mL of test material was applied to a skin area of 2.5 x 2.5 cm under occlusive conditions for 24 hours. The application site was either intact or scarified. The application site on the intact skin was located dorsally whereas scarified skin was located on the left side. Skin findings were assessed after 24 hours, 48 hours, 72 hours and after 8 days. The assessment of the findings was based on the Federal Reg. 38, No. 187, Para. 1500.41, page 27029 (1973). - GLP compliance:
- no
Test material
- Reference substance name:
- Antimony nickel titanium rutile
- EC Number:
- 701-459-6
- Cas Number:
- 8007-18-9
- Molecular formula:
- Ni(x/3)Sb(2x/3)Ti(1-x)O2 0,1≤x≤0,3
- IUPAC Name:
- Antimony nickel titanium rutile
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 2.50 kg
- Diet: Sniff
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- Concentration: 50 %
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 8 d
- Number of animals:
- 6 (4 male, 2 female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 * 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 4
- Remarks on result:
- not determinable
- Remarks:
- evaluation of erythema after 24 h not possible due to treatment related staining.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Intact skin: Evaluation of erythema after 24 h not possible due to treatment related staining. No oedema or erythrema noted during the entire evaluation period.
Abraded skin: Evaluation of erythema after 24 h not possible due to treatment related staining. After 72 h questionable to slight erythema in 3/5 animals (1 animal evaluation impossible due to substance-related staining); scaling in 4 animals after 8 d. Edema: no effects
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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