Registration Dossier
Registration Dossier
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EC number: 608-748-5 | CAS number: 324763-46-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.11.2003 - 21.11.2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one
- EC Number:
- 608-748-5
- Cas Number:
- 324763-46-4
- Molecular formula:
- C25 H39 N3 O5
- IUPAC Name:
- (3S,5S)-5-[(1S,3S)-1-azido-3-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-4-methylpentyl]-3-(propan-2-yl)oxolan-2-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeding farm Bio Test, Konárovice
- Weight at study initiation: 3150 - 3300 g
- Housing: Animals were housed individually in cages without bedding.
- Diet: pelleted standard diet TM-MAK1 for rabbits and guinea pigs (Bergman, Kocanda Mill), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 17.11.2003
To: 21.11.2003
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Not required, the untreated sites of each animal served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, moistened with 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 applied test substance was covered by a gauze patch, foil and cellulose cotton and held in place with non-irritant tape (Spofaplast).
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No irritative effect on skin was observed in any animal during the observation period.
Any other information on results incl. tables
In the course of study no other signs of toxicity of the test substance were observed in test animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to REGULATION (EC) No 1272/2008 (CLP) the test substance does not require classification for skin irritation.
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