Registration Dossier
Registration Dossier
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EC number: 616-391-1 | CAS number: 76812-02-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sample reception: 31-10-1997 / Study completion date: 06-03-1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- EC Number:
- 616-391-1
- Cas Number:
- 76812-02-7
- Molecular formula:
- C34 H41 N O4
- IUPAC Name:
- 4-[4-[4-(Hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-ethyl ester benzeneacetic acid
- Reference substance name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- IUPAC Name:
- 4-(4-(4-Hydroxydiphenylmethyl)-1-piperidinyl)-1-oxobutyl- alpha,alphadimethylbenzeneacetic acid ethyl ester
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FEXOFENADONETHYLESTER
- Physical state: white powder
- Lot/batch No.: TAM 40/96/13
- Date of receipt: 31 October 1997
- Stability condition of test material: at +4°C and protected from light.
- The pH of the test substance at the concentration of 10% in purified water, measured at C.I.T., was approximately 6 to 7.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Weight: on the day of treatment, the animals had a mean body weight of 2.9 ± 0.2 kg.
Acclimatization: at least 5 days before the beginning of the study.
Housing conditions: polystyrene cages (35 cm x 55 cm x 32 cm or 48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle.
Food: free access to 112 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France).
Water: filtered by a F.G. Millipore membrane (0.22 µ)
Environmental conditions
. Temperature: 18 ± 3°C
. Relative humidity: 30 to 70%
. Light/dark cycle: 12 h/12 h
. Ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin served as control.
- Amount / concentration applied:
- A single dose of 500 mg of the test substance was placed on a 6 cm² moistened gauze pad which was then applied to the right flank of the animals for 4 hours.
- Duration of treatment / exposure:
- As possible irritant effects were anticipated, the test substance was evaluated in one animal (No. 01) in a first assay. The duration of exposure was 4 hours on the right flank.
Since the test substance was not strongly irritant in this first assay, it was then applied for 4 hours to two other animals (Nos. 02 and 03) in a second assay. - Observation period:
- The skin was examined approximately 1 hour, 24,48 and 72 hours after removal of the dressing.
- Number of animals:
- 3 animals were used, as recommended by the international guidelines and taking into account that a good correlation of results can be obtained with either three or six animals. The animals were identified individually with a metal tag in the ear.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under our experimental conditions, the test substance FEXOFENDONETHYLESTER is non-irritant when applied topically to rabbits.
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