Registration Dossier
Registration Dossier
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EC number: 605-260-4 | CAS number: 161599-46-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1995 - January 1996
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.41
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (2R,3R,4R,5R)-4-(acetyloxy)-5-(4-amino-5-fluoro-2-oxo-1,2-dihydropyrimidin-1-yl)-2-methyloxolan-3-yl acetate
- EC Number:
- 605-260-4
- Cas Number:
- 161599-46-8
- Molecular formula:
- C13 H16 F N3 O6
- IUPAC Name:
- (2R,3R,4R,5R)-4-(acetyloxy)-5-(4-amino-5-fluoro-2-oxo-1,2-dihydropyrimidin-1-yl)-2-methyloxolan-3-yl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Roche number RO 09-2216
Lot 23521-282B
white powder
10 g of test article was mixed with distilled water to a volum of 20ml (50% w/v)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 10 g of test article was mixed with distilled water to a total volume of 20 ml (50 % w/v).
- Duration of treatment / exposure:
- The sites were occluded for 24 hours at which time the patches were removed.
- Observation period:
- Animals were observed for skin reactions at 24 and 72 hours after application of the test article.
- Number of animals:
- 6
- Details on study design:
- The test article was used as a 50% w/v mixture in distilled water.
1.0 ml of the test article dilution (0.5 g of the test article) was applied to two areas, 1 intact and 1 abraded, on the prepared site, on the
back of each of six rabbits.
The treated sites were covered with a four-layered 2.5 cm square surgical gauze patches which were secured with non-irritating tape. The torso was wrapped with plastic which was secured with non· irritating tape.
The sites were occluded for 24 hours at which time the patches were removed.
Any residual test article was gently rinsed off with distilled water prior to dermal observations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Irritant / corrosive response data:
- Primary dermal irritation index = summe of mean scores/4 = 0
- Other effects:
- Systemic observations : normal
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: 16 CFR 1500.41
- Conclusions:
- The primary irritation index is 0. Therefore, the test article dilution is a non-irritant as defined in 16 CFR 1500.3(c)(4).
- Executive summary:
Six healthy New Zealand Albino Rabbits were dosed dermally with a dilution of RO #09·2216, Lot #23521-282B.
1,0 ml of the test article dilution (0,5 g of the test article) was applied to 1 intact and 1 abraded site on the clipped back for a total dose of 2,0 ml/rabbit.
The sites were occluded for 24 hours. The skin reactions were evaluated by the Draize technique at 24 and 72 hours after dosing.
Body weights were recorded pretest. The Primary Irritation Index was calculated.
No erythema, edema or abnormal physical signs were noted during the observation period.
The Primary Irritation Index is 0. Therefore, the test article dilution is a nonirritant as defined in 16 CFR 1500.8(c)(4).
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