Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 619-383-6 | CAS number: 98967-40-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 31 May 1988 to 5 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 81-6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
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:
- N-(2',6'-difluorophenyl)-5-methyl[1,2,4]triazolo[1,5-a]pyrimidine-2-sulfonamide
- IUPAC Name:
- N-(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
- Analytical purity: 99.6%
- Physical state: white powder
- Lot/batch No.: AGR 240043
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston NY
- Weight at study initiation: 340 to 405 g
- Housing:Five per cage
- Diet (e.g. ad libitum): Purina Certified Guinea Pig Chow #5026, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: one week
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 g aliquot of test material was applied under gauze patch
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 g aliquot of test material was applied under gauze patch
- No. of animals per dose:
- 10 males per control, and 10 males per 0.4 g dose
- Details on study design:
- RANGE FINDING TESTS:
A single application of 200 mg of the dry test material was topically applied to the clipped skin or two guinea pigs for 6 hours. Skin irritation readings were recorded 24 and 48 hours later. Based on the restuls of the skin irritation screen, the dry test material was not irritating and was chosen for the study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: once per week for three weeks
- Test groups: a 0.4 g aliquot of the test material was applied to the left side of ten guinea pigs under a gauze patch
- Control group: 10% solution of DER 331 epoxy resin in diproplylene glycol monomethyl ether was used as a positive control and applied in a similarmanner in Hill Top Chambers.
- Site: left side of guinea pig
- Frequency of applications: once
- Duration: 6 hours
- Concentrations: 0.4 g aliquot of test material
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 2
- Exposure period: 6 hours
- Test groups: a 0.4 g aliquot of the test material was applied to the left side of ten guinea pigs under a gauze patch, then on the next day the application sites were depilated with Neet hair cream remover
- Control group: 10% solution of DER 331 epoxy resin in diproplylene glycol monomethyl ether was used as a positive control and applied in a similarmanner in Hill Top Chambers, then on the next day the application sites were depilated with Neet hair cream remover
- Site: right side of guinea pig
- Evaluation (hr after challenge): 24 and 48 hours after challenge
- Challenge controls:
- The ten guinea pigs that were used in the induction phase were also used in he challenge phase. A 10% solution of DER 331 epoxy resin in dipropylene glycol monomethyl ether was used as a positive control in the induction phase and applied in Hill Top Chambers. The same guinea pigs were treated in the induction phase with the same substance, except on the right instead of left side of the body. The following day, after the 6 hour challlenge, the application sites were depilated with Neet hair cream remover.
- Positive control substance(s):
- yes
- Remarks:
- 10% solution of DER 331 epoxy resin in dipropylene glycol monomethyl ether
Study design: in vivo (LLNA)
- Statistics:
- NDA
Results and discussion
- Positive control results:
- Challenge application of the positive control caused slight to moderate erythema in seven of ten animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4 g
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.4 g. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.4 g
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.4 g. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% DER 331
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- slight to moderate erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 10% DER 331. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: slight to moderate erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% DER 331
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- slight to moderate erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 10% DER 331. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: slight to moderate erythema.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: no information
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: no information
Any other information on results incl. tables
| Individual Animal Dermal Observations | |||||||
| Treatment Group | Animal Number | Induction | Dermal Response | Response | |||
| 1 | 2 | 3 | 24 hours after challenge | 48 hours after challenge | |||
| Treatment: 400 mg XRD-498 | 88A2873 | 0 | 0 | 0 | 0 | 0 | - |
| 88A2874 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2875 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2876 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2877 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2878 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2879 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2880 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2881 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2882 | 0 | 0 | 0 | 0 | 0 | - | |
| Control: 10% DER 331 | 88A2883 | 0 | 0 | 0 | 1 | 2 | + |
| 88A2884 | 0 | 0 | 0 | 0 | 1 | + | |
| 88A2885 | 0 | 0 | 0 | 1 | 2 | + | |
| 88A2886 | 0 | 0 | 0 | 0 | 1 | + | |
| 88A2887 | 0 | 0 | 0 | 1 | 1 | + | |
| 88A2888 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2889 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2890 | 0 | 0 | 0 | 0 | 0 | - | |
| 88A2891 | 0 | 0 | 0 | 0 | 1 | + | |
| 88A2892 | 0 | 0 | 0 | 0 | 1 | + | |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Challenge application of XRD-498 caused no reaction in any of the animals. Under the conditions of this study, XRD-498 did not cause delayed contact hypersensitivity in guinea pigs.
- Executive summary:
XRD-498 was evaluated for dermal sensitization potential using a modified Buehler method. Ten male Hartley albino guinea pigs received three applications of XRD-498 during the induction phase of the study. A positive control group recieved three applications of 10% DER 331 epoxy resin during the induction phase. The respective groups were challenged with XRD-498 or 10% DER 331 two weeks after the last induction application. The condition of the test sites was assessed approximately 24 and 48 hours after the challenge application. Challenge application of the positive control caused slight to moderate erythema in seven of ten animals. It was therefore concluded that, under the conditions of this study, XRD-498 did not cause delayed contact hypersensitivity in guinea pigs.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
