Registration Dossier
Registration Dossier
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EC number: 701-059-1 | CAS number: 345217-03-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In-vivo study completed
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 December to 04 December, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- OECD ENV/MC/CHEM(98)17
Test material
- Reference substance name:
- 2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
- EC Number:
- 701-059-1
- Cas Number:
- 345217-03-0
- Molecular formula:
- C43H50F2N8O4
- IUPAC Name:
- 2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
- Test material form:
- other: White solid
- Details on test material:
- stored at room temp in the dark.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbank, Chesire, UK.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 3.03 -3.16 kg
- Housing: Individually in suspended metal cages.
- Diet: STANRAB SQC Rabbit diet, ad libitum
- Water: Mains, ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16° - 20°C
- Humidity (%): 43 - 52%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs continous light and 12 hrs dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistened with 0.5 ml distilled water.
- Controls:
- other: contralateral zone of same animal
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4hr
- Observation period:
- 1hr, 24hr, 48hr and 72hr after dressing removed.
- Number of animals:
- 3
- Details on study design:
- Moistened test material introduced under a 25cm x 25cm cotton gauze patch.
4 hrs after application the patches were removed and any residual test material removed by gentle swabbing with cotton wool soaked in Distilled water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hr
- Score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: overall at 1, 24, 48 and 72 h
- Score:
- 0
- Other effects:
- No other adverse skin reactions were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme.
- Executive summary:
The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme.
No corrosive effects were noted.
The material did not meet the criteriaa for classification as irritant or corrosive according to EU labelling regulations.
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