Registration Dossier
Registration Dossier
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EC number: 920-205-7 | CAS number: 1035204-85-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 27 January to 06 February 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- tert-butyl 2-[(7R,9R)-9-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-6,10-dioxaspiro[4.5]decan-7-yl]acetate
- EC Number:
- 920-205-7
- Cas Number:
- 1035204-85-3
- Molecular formula:
- C42H49FN2O5
- IUPAC Name:
- tert-butyl 2-[(7R,9R)-9-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-6,10-dioxaspiro[4.5]decan-7-yl]acetate
- Details on test material:
- Batch No.: TCA-153-74
Purity: 98%
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, Gannat, France
- Age at study initiation: 10-20 weeks old
- Weight at study initiation: 2-4 kg
- Housing: Animals were individually housed in labeld cages with perforated floors and shelters.
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 ℃
- Humidity (%): 30-70% (actural range: 42-71%)
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artifical fluorescent light and 12 hours darkness per day
IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: watery ethanol
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL
No additional data - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 150 square centimeters (10×15 cm)
- Type of wrap if used: The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin cleaned of residual test substance using tap water.
- Time after start of exposure: four hours
No additional data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritant / corrosive response data:
- Irritation
No skin irritation was caused by 4 hours exposure to the test substance.
Corrosion
There was no evidence of a corrosive effect on the skin. - Other effects:
- Coloration / Remnants
No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual skin irritation scores
Animal |
1241 |
123 |
125 |
||||||
Time after exposure |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
Erythema |
Oedema |
comments |
1 hour |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
24 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
48 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
72 hours |
0 |
0 |
- |
0 |
0 |
- |
0 |
0 |
- |
1Sentinel.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Treatment with the test substance caused no skin irritation in three (3/3) rabbits.
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