Registration Dossier
Registration Dossier
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EC number: 215-174-5 | CAS number: 1309-60-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- September-December 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-documented and corresponded to the requirements of the recommended Annex V Test Guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Lead monoxide
- EC Number:
- 215-267-0
- EC Name:
- Lead monoxide
- Cas Number:
- 1317-36-8
- Molecular formula:
- OPb
- IUPAC Name:
- Plumbanone
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left side of the back served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 0.5 g
- Observation period:
- 1, 24, 48, and 72 hours after exposure.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Clipped skin on the right side of the back of rabbit
- % coverage:
- Type of wrap if used: Gauze patch
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Grading of skin as stipulated by OECD 404
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours after the end of the 4 hour exposure
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- There were no skin irritating findings with the exception of very slight signs of erythema observed 1 hour after patch removal in all three animals.
The mean grades at 24, 48, and 72 hours after the end of exposure were "0" in each animal. - Other effects:
- No general toxic effects were seen
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD 404
- Conclusions:
- The test article was classsified on the basis of the mean values of skin reactions 24, 48 and 72 hours after the end of the 4-hour exposure accordingto the EEC Directive 2001/59/EEC of 6 August 2001. the test article "LITHARGE lead oxide" is classified as "non-irritant."
- Executive summary:
The following results were obtained:
-No signs of erythema and oedema were observed
-No general toxic effects were seen
-The mean grades at 24, 48, and 72 hours after the end of exposure were "0" in each animal.
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