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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 279-935-3 | CAS number: 82338-76-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from HSDB.
Data source
Reference
- Reference Type:
- other: authoritative database
- Title:
- Subchronic toxicity study for Ametryne in Rat
- Author:
- U. S. National Library of Medicine
- Year:
- 2 017
- Bibliographic source:
- HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC, 2017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- To evaluate the toxicity of Ametryne in rats by subchronic study by oral gavage.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ametryn
- EC Number:
- 212-634-7
- EC Name:
- Ametryn
- Cas Number:
- 834-12-8
- Molecular formula:
- C9H17N5S
- IUPAC Name:
- 2-ethylamino-4-isopropylamino-6-methylthio-1,3,5-triazine
- Details on test material:
- - Name of test material (as cited in study report): Ametryne (2-ethylamino-4-isopropylamino-6-methylthio-1,3,5-triazine)
- Molecular formula (if other than submission substance): C9H17N5S
- Molecular weight (if other than submission substance): 227.3343 g/mole
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- not specified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- 6 days/week
Doses / concentrations
- Remarks:
- 0,100, 250, or 500 mg/kg/day
- No. of animals per sex per dose:
- Total number of animals 40
0 mg/kg/day 10 male and female
100 mg/kg/day 10 male and female
250 mg/kg/day 10 male and female
500 mg/kg/day 10 male and female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY: Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Not specified
- Statistics:
- Not specified
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At the dose level of 500 mg/kg/day treated animals became emaciated compare to control.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 7of 10 rats were died at the dose level of 500 mg/kg/day of treated animals compare to control.
1of 10 rats were died at the dose level of250 mg/kg/day of treated animals compare to control. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease in weight gain was observed at the dose level of 500 and 250mg/kg/day of treated animals compare to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- At the dose level of 500 mg/kg/day in treated animals severe vascular congestion, centrilobular liver necrosis and fatty degeneration of individual liver cells were observed compare to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant change were observed at this dose.
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 100mg/kg/day for Ametryne(834-12-8)in male and female rats by subchronic study by oral gavage.
- Executive summary:
Repeated dose toxicity study for Ametryne was assessed to evaluate its toxic potential. The test material was exposed at the concentration of0,100, 250, or 500 mg/kg/day in male and female rats by oral gavage for 28 days. The rats were observed for clinical sign,mortality,body weight ,gross and histipathology.Mortality wasobserved at the dose level of 250 and 500mg/kg/day. At the dose level of 500 mg/kg/day in treated animals severe vascular congestion, centrilobular liver necrosis and fatty degeneration of individual liver cells were observed compare to control. No significant effect and mortality was observed at 100 mg/kg/dayin any treated animals. Therefore NOAEL was considered to be 100 mg/kg/day inmale and female rats by subchronic study by oral gavage.
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.
