Registration Dossier
Registration Dossier
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EC number: 610-122-1 | CAS number: 433733-94-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5.5.2009 - 15.5.2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- [(2S,3R,5S)-3-acetoxy-5-(5-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-2-yl]methyl acetate
- EC Number:
- 610-122-1
- Cas Number:
- 433733-94-9
- Molecular formula:
- C14H18N2O7
- IUPAC Name:
- [(2S,3R,5S)-3-acetoxy-5-(5-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-2-yl]methyl acetate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan France SARL, France
- Age at study initiation: at least 7 - 10 weeks
- Weight at study initiation: at least 1525 - 1751 g
- Housing: Animals were housed individually in cages with perforated floors and shelter.
- Diet: SSNIFF K-H pelleted diet for rabbits, approximately 100 g/d
- Water: tap water, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 - 23.2
- Humidity (%): 26 - 72
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 5.5.2009
To: 8.5.2009
From: 12.5.2009
To: 15.5.2009
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: Not required, the untreated skin of each animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 g test substance moistened with 0.5 mL water - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Type of wrap if used: The test substance was applied on one flank and covered with a metalline patch and Micropore tape. The dressing was held in place with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was cleaned using tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin irritation was caused by 4 hours exposure to the test substance. There was no evidence of a corrosive effect on the skin.
- Other effects:
- No staining of the treated skin by the test substance was observed and no test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No skin irritation was caused by 4 hours exposure to LDT600 C3.
CLP: not classified
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