Registration Dossier
Registration Dossier
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EC number: 603-373-3 | CAS number: 129909-90-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 March 1994 to 25 March 1994
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- (1984)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Version / remarks:
- (1989)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200 (Guidance on toxicology study data for application of agriculture chemical registration) (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- EC Number:
- 603-373-3
- Cas Number:
- 129909-90-6
- Molecular formula:
- C10H19N5O2
- IUPAC Name:
- 4-amino-N-tert-butyl-5-oxo-3-(propan-2-yl)-4,5-dihydro-1H-1,2,4-triazole-1-carboxamide
- Reference substance name:
- Technical Grade MKH 3586
- IUPAC Name:
- Technical Grade MKH 3586
- Details on test material:
- - Name of test material (as cited in study report): Technical Grade MKH 3586
- Physical state: Beige powder
- Analytical purity: 97.8 - 98.2%
- Purity test date: 17 Jun 1994
- Lot/batch No.: 17004/93
- Expiration date of the lot/batch: 6 months from date of purity testing
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes, 24, 48 and 72 hrs post removal of the patch
- Number of animals:
- 6 males/dose group
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: All time points
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: No erythema or oedema was present
Any other information on results incl. tables
OBSERVATIONS:
Clinical / skin:
No clinical signs of toxicity or other lesions were observed. No erythema or oedema were evident at the dose site of any animal following exposure, therefore the result of the PII of 0.0 was calculated.
Mortality:
All animals survived to the end of the experimental phase.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material returned a PII of 0.0 and is therefore considered non-irritating.
- Executive summary:
In a primary dermal irritation study, 6 young adult male New Zealand rabbits were exposedviathe dermal route to 0.5 mL of MKH 3586/animal. The test material was administered semi occluded as supplied (moistened with a small amount of water) for 4 hours to a clipped area of intact skin. Animals were then observed up to 72 hours post end of treatment. Irritation was scored using the primary irritation index grading scheme.
No clinical signs of toxicity or other lesions were observed. No erythema or oedema were evident at the dose site of any animal following exposure
Under the conditions of this study, the test material returned a PII of 0.0 and is therefore considered non-irritating.
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