Registration Dossier
Registration Dossier
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EC number: 603-434-4 | CAS number: 130755-46-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 406); GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted in 1996, GPMT was method of choice at the time. No new LLNA test is required since GPMT available is of good quality and allows hazard assessment for skin sensitization.
Test material
- Reference substance name:
- 5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
- EC Number:
- 603-434-4
- Cas Number:
- 130755-46-3
- Molecular formula:
- C22 H8 Cl4 F6 N8 S2
- IUPAC Name:
- 5-amino-4-({5-amino-3-cyano-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazol-4-yl}disulfanyl)-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-1H-pyrazole-3-carbonitrile
- Details on test material:
- - Name of test material (as cited in study report): Disulfide / MB 46307 / RPA 98028 Intermediate of Fipronil (MB 46030).
- Physical state: yellow powder.
- Lot/batch No.: OP 9550151.
- Storage condition of test material: at room temperature.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre d'Elevage Lebeau, 78950 Gambais, France.
- Age at study initiation: approximately three months.
- Weight at study initiation: 328±16 g for the males and 320±19 g for the females.
- Housing: individually in polycarbonate cages.
- Diet (e.g. ad libitum): 106 diet (U.A.R., 91360 Villemoisson-sur-Orge, France), ad libitum.
- Water (e.g. ad libitum): Drinking water filtered by Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C.
- Humidity (%): 30 - 70%.
- Air changes (per hr): about 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1st induction: 10% intradermal injection;
2nd induction: 20% topical application;
1st challenge: 20% topical application;
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1st induction: 10% intradermal injection;
2nd induction: 20% topical application;
1st challenge: 20% topical application;
- No. of animals per dose:
- control group: 10 (5 males + 5 females);
test group: 20 (10 males + 10 females); - Details on study design:
- RANGE FINDING TESTS:
A preliminary test was conducted in order to determine the concentrations to be tested in the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 48 h
- Site: dorsal region between the shoulders
- Concentrations: 1st induction: 10% intradermal injection; 2nd induction: 20% topical application
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 h
- Site: posterior right and left flank
- Concentrations: 20%
- Evaluation (hr after challenge): 24 and 48 h
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro chlorobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 20% . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1%. No with. + reactions: 20.0. Total no. in groups: 20.0.
Any other information on results incl. tables
No clinical signs and no deaths were noted during the study. No cutaneous reactions were observed after the challenge application. The guinea-pigs which were used in a recent study, showed a satisfactory sensitization response in 100% animals using a positive sensitizer.
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, no cutaneous reactions attributable to the sensitization potential of the test substance at a concentration of 20% were observed in guinea-pigs.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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