Registration Dossier
Registration Dossier
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EC number: 212-634-7 | CAS number: 834-12-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- unscheduled DNA synthesis
Test material
- Reference substance name:
- Ametryn
- EC Number:
- 212-634-7
- EC Name:
- Ametryn
- Cas Number:
- 834-12-8
- Molecular formula:
- C9H17N5S
- IUPAC Name:
- N2-ethyl-6-(methylsulfanyl)-N4-(propan-2-yl)-1,3,5-triazine-2,4-diamine
- Details on test material:
- - Name of test material (as cited in study report): Ametryn technical (N2-Ethyl-N4-Isopropyl-6-Methylthio-1,3,5-triazine-2,4-diamine)
- Physical state: White powder
- Analytical purity: 100.4%
- Lot/batch No.: 825
- Expiration date of the lot/batch: 24 March 1996
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: Approximately 6 weeks old (5 weeks old at receipt + 1 week acclimatization)
- Weight at study initiation: 140 to 149 g
- Housing: Groups of rats kept in a plastic disposable cages with stainless steel grid tops
- Diet (e.g. ad libitum): Biosure LAD 1 rodent diet ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 to 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 ºC
- Humidity (%): 42 to 69%
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 hours: 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Reported as "aqueous 1% methyl cellulose"
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Freshly prepared on the day of use
- Duration of treatment / exposure:
- Single administration
- Frequency of treatment:
- Single administration
- Post exposure period:
- 2 or 14 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 480, or 1600 mg/kg bw
Basis:
actual ingested
- DNA Repair test
- No. of animals per sex per dose:
- 4 males/test article or vehicle control group and 2 males/positive control group (for both the 2 hour and 14 hour time point)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- 2-acetylaminofluorene (14 hour time-point) and N-dimethylnitrosamine (2 hour time-point)
- Route of administration: Oral (gavage)
- Doses / concentrations: 50 mg/kg (2-acetylaminofluorene) and 4 mg/kg (N-dimethylnitrosamine)
Examinations
- Tissues and cell types examined:
- Hepatocytes isolated from the rats' livers
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION: Autoradiographs were prepared from 6 cultures/animal; emulsion was applied to the slides in the dark room. The emulsion was melted and each slide was dipped into the emulsion, withdrawn, excess emulsion was wiped off the back of the slide and it was placed on a chilled metal plate for a few minutes to allow the emulsion to gel. The autoradiographs were exposed for 14 days at approximately 4 ºC.
METHOD OF ANALYSIS: Grain counts were performed using a Zeiss Photomicroscope II - Evaluation criteria:
- A positive response is normally indicated by a substantial dose-associated statistically significant increase in the net nuclear grain count which is accompanied by a substantial increase in the gross nuclear grain count over concurrent control values.
- Statistics:
- One-way ANOVA and Student's t-test
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- - piloerection, lethargy, ptosis, and hunched position noticed in some of the animals, with degrees of reaction ranging from slight to severe (only in 1 animal). No mortalities occurred.
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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