Registration Dossier
Registration Dossier
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EC number: 619-383-6 | CAS number: 98967-40-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 June 1988 to 3 August 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(2,6-difluorophenyl)-5-methyl-[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- EC Number:
- 619-383-6
- Cas Number:
- 98967-40-9
- Molecular formula:
- C12H9F2N5O2S
- IUPAC Name:
- N-(2,6-difluorophenyl)-5-methyl-[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- Reference substance name:
- N0(2',6'-difluorophenyl)-5-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- IUPAC Name:
- N0(2',6'-difluorophenyl)-5-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- Details on test material:
- - Name of test material (as cited in study report): XRD-498
- Physical state: white powder
- Analytical purity: 99.6%
- Lot/batch No.: AGR-240043
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver PA
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period:2 weeks
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free of fur
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A 0.5 g aliquot of test material applied under a 2.5 cm2 gauze patch
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes, 24 hours, 48 hours, 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back of rabbits
- % coverage: 2.5 cm2
- Type of wrap if used: A 0.5 aliquot of test material was applied to the back under a 2.5 cm2 gauze patch and held in place with non-irritating tape. The gauze patch was covered with a flannel bandage taped to the rabbit. The rabbits were returned to individual cages following application of the test material.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with a damp disposable towel to remove any residual test substance.
- Time after start of exposure: 4 hours
SCORING SYSTEM: 0 to 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: all 6 animals
- Time point:
- other: 30 min, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal:
- Time point:
- other: 30 min, 24h, 48h, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- see table in "remarks on results"
scores of 0 indicate no erythema or no edema
Any other information on results incl. tables
| Individual Rabbit Skin Irritation Grades | |||
| Observation time following patch removal | Animal Number | Erythema | Edema |
| within 30 minutes | 88A2920 | 0 | 0 |
| 88A2921 | 0 | 0 | |
| 88A2922 | 0 | 0 | |
| 88A2923 | 0 | 0 | |
| 88A2924 | 0 | 0 | |
| 88A2925 | 0 | 0 | |
| 24 hours | 88A2920 | 0 | 0 |
| 88A2921 | 0 | 0 | |
| 88A2922 | 0 | 0 | |
| 88A2923 | 0 | 0 | |
| 88A2924 | 0 | 0 | |
| 88A2925 | 0 | 0 | |
| 48 hours | 88A2920 | 0 | 0 |
| 88A2921 | 0 | 0 | |
| 88A2922 | 0 | 0 | |
| 88A2923 | 0 | 0 | |
| 88A2924 | 0 | 0 | |
| 88A2925 | 0 | 0 | |
| 72 hours | 88A2920 | 0 | 0 |
| 88A2921 | 0 | 0 | |
| 88A2922 | 0 | 0 | |
| 88A2923 | 0 | 0 | |
| 88A2924 | 0 | 0 | |
| 88A2925 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: US EPA pesticides
- Conclusions:
- There were no signs of dermal irritation in any of the rabbits at any time post-treatment.
- Executive summary:
Aliquots of 0.5 g of XRD-498 were applied for four hours to the intact skin on the back of six New Zealand White rabbits. No signs of dermal irritation were observed at any time post-treatment. XRD-498 was not irritating to the skin of rabbits.
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