Registration Dossier
Registration Dossier
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EC number: 603-373-3 | CAS number: 129909-90-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 July 1994 to 10 August 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Version / remarks:
- (1984)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- 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 type:
- standard acute method
- Limit test:
- 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 power
- 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 purity test date
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- 0, 2000 mg/kg
- No. of animals per sex per dose:
- 6 animals/sex/dose group
- Control animals:
- yes, concurrent no treatment
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: no mortality observed
Any other information on results incl. tables
OBSERVATIONS:
Clinical signs of toxicity:
No test material related signs of toxicity were observed
Mortality:
All animals survived to the scheduled necropsy
Bodyweight and bodyweight gain:
No test material related changes were observed
Sacrifice and Gross Pathology:
No gross lesions attributed to the test material were observed
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the single dose acute dermal LD50 of MKH 3586 is greater than 2000 mg/kg in male and female rats.
- Executive summary:
An acute dermal toxicity test was conducted with rats to determine the potential for MKH 3586 to produce toxicity from a single topical application.
Two thousand milligrams of the test material/kg was applied to the skin of 12 healthy rats for 24 hours (6/sex). A concurrent control group of the same size were also used (not stated if these were dosed with vehicle or not). The animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.
All animals survived, gained body weight and appeared active and healthy during the study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
Under the conditions of this study, the single dose acute dermal LD50 of MKH 3586 is greater than 2000 mg/kg in male and female rats.
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