Registration Dossier
Registration Dossier
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EC number: 483-270-6 | CAS number: 54068-28-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- july to august 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Groupe Interministeriel Des Produits Chimiques, Paris, France
Test material
- Reference substance name:
- -
- EC Number:
- 483-270-6
- EC Name:
- -
- Cas Number:
- 54068-28-9
- Molecular formula:
- Hill formula: C26H48O4Sn CAS formula: C26H48O4Sn
- IUPAC Name:
- (3Z)-4-{[dioctyl({[(2Z)-4-oxopent-2-en-2-yl]oxy})stannyl]oxy}pent-3-en-2-one
- Details on test material:
- VP07-560
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- weight: 2.41 - 3.00 kg
temperature: 19 - 24°C
relative humidity: 43 -66 %
lighting time: 12 hours daily
rate of air exchange: at least ten changes per hour
Test system
- Type of coverage:
- other: patch, secured with surgical adhesive tape
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all
- Time point:
- other: 1 hour
- Score:
- > 0 - < 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: between D2 and D4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- > 0 - < 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: between D1 and D3
- Other effects:
- On the cutaneous structure. a slight dryness was noted on the treated area, from D3 in three animals. The skin recovered a normal
aspect between D8 and D10.
Any other information on results incl. tables
see study report
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU, OECD GHS
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item
TIB KAT 223, according to the scales of interpretation retained:
- is irritant to skin (PSi = 2.3) according to the classification established in the Journal Officiel de la
République Française dated February 21st, 1982,
- and, must not be classified, according to the criteria for classification, packaging and labelling of
dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59
and 99/45. No symbol and risk phrases are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not
be classified in category 2 “Irritant”. No signal word and hazard statement are required. - Executive summary:
see study report
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