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EC number: 212-634-7 | CAS number: 834-12-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in compliance with guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 82-2 (Repeated Dose Dermal Toxicity -21/28 Days)
- Deviations:
- no
- GLP compliance:
- yes
- 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:
- N2-ethyl-6-(methylsulfanyl)-N4-(propan-2-yl)-1,3,5-triazine-2,4-diamine
- Details on test material:
- Name: Ametryn Tecnical (FL 840991)
Purity: 97,4 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM: 22 male and 22 female New Zealand white rabbits were received from H.A.R.E., Inc. Hewitt, New Jersey on July 7, 1988. Upon arrival at the Safety Evaluation Facility (SEF), all animals were assigned to individual cages. The rabbits were acclimated to laboratory conditions for about three weeks prior to dosing. ,The rabbits were offered a daily ration of Purina Rabbit Chow 5325 and had tap water ad libitum via an automatic delivery system. The feed and drinking water were monitored for contaminants according to the Standard Operating Procedures (SOPs) of the SEP. Only those animals judged healthy on the basis of general observations, body weights, physical/auditory examinations, and clinical laboratory evaluations that were performed during the predose period were utilized for this study. Prior to the initiation of dosing, rabbits were randomly assigned to treatment groups via the Beckman TOXSYS (R) Computer System. Rabbits not assigned to the study were returned to stock. Animals were identified with Monel ear tags according to the SOPs of the SEP. Study animals were approximately 14-15 weeks of age and weighed 2.35 to 3.00 kg just prior to dosing.
ANIMAL QUARTERS: All rabbits in this study were housed at the Summit facilities in a single animal room in the SEP. The room was maintained at a daily temperature of 65 ± 5 °F and a relative humidity of 50 ± 20%, whenever possible. Room temperature and humidity were monitored throughout the study according to the SOPs of the SEP. In addition, the animal room was supplied daily with 12 hours of continuous artificial light and was closely monitored so that no unusual activities interfered with the conduct of the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on exposure:
- Prior to dosing and as needed during the study, each rabbit was prepared by clipping the skin of the flank and back free of hair. Ametryn was weighed neat, moistened with sterile water, and applied daily to an area of intact skin comprising approximately 5 to 10% (approximately 120 to 240 sq. cm.) of the total body surface of the rabbits. A gauze dressing was applied over the test site and secured to the animal with adhesive wrapping. Following dosing, each animal was fitted with an Elizabethan collar and returned to its cage. The compound remained in contact with the skin for approximately 6 hours daily. One group of rabbits was similarly treated with sterile water and did not receive the test substance. Following the dosing period, the gauze dressing was removed, and the treatment site was gently washed with tap water and dried with a paper towel. Each animal was then returned to its cage overnight.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- The compound was applied to shaved skin for approximately 6 hours daily.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (G1), 10 (G2), 100 (G3), 1000 (G4) mg/kg
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 40 animals: 5 male and 5 femal for each dose level
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The dermal LD50 of Ametryn Technical is greater than 2010 mg/kg . Twenty-one day dermal toxicity studies in rabbits have been completed for other triazine herbicides at high doses without any adverse effects. It was determined, therefore, that the rabbit would tolerate Ametryn Technical at a dermal dose of up to 1000 mg/kg/day in this study. The no observable effect level was projected to be at least 10 mg/kg.
- Rationale for animal assignment: randomly via computer system - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- see below
- Sacrifice and pathology:
- see below
- Other examinations:
- see below
- Statistics:
- see below
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- see below
Effect levels
open allclose all
- Dose descriptor:
- other: Maximum tolerated dose (MTD)
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
1. Mortality, Clinical Signs, and Physical/Auditory Examinations
All animals survived the study. There were no clinical signs observed during the study, and physical/auditory examinations that were conducted at the end of the study were unremarkable.
2. Dermal Observations
There were no treatment-related dermal changes noted in any animal throughout the study.
3. Body Weight
There were no treatment-related effects on mean body weight data during the study or at the time of necropsy. A transient treatment-related decrease in mean percent body weight gain was noted in the high-dose males and females on test day 8; the change was statistically significant only in the males.
4. Food Consumption
A transient reduction in mean food consumption was noted in high-dose males and females on test day 8. This change was statistically significant only in the males. Food consumption for all animals throughout the remainder of the study were similar to controls.
5. Ophthalmoscopic Examination
No treatmentrelated ophthalmoscopic changes were observed at the end of the study.
6. Hematology
There were no treatment-related changes in any hematologic parameter at the end of the study. Statistically significant differences in percent neutrophils and lymphocytes were noted in the high-dose males when compared to the concurrent controls. These differences were considered to be incidental to treatment based upon the absence of a dose-response relationship and because these differences were also present during predose.
7. Biochemistry
Statistically significant increases in mean serum cholesterol and triglycerides were observed in the high-dose males and females at the end of the study. These differences did not correlate with any organ weight effects or gross and microscopic pathology and are not considered to be of any toxicologic significance. A statistically significant increase in gaituna glutainyl transpeptidase was noted in Group 3 and 4 males, but not females, on test day 20. Since individual values for this parameter showed variations predose that were similar to those on test day 20, the relationship of this change to treatment is unknown. A statistically significant decrease in mean serum alkaline phosphatase was observed in the low-dose females at the end of the study. Since there was no dose-response or any toxicologic significance to this change it is not considered related to dosing with Ametryn.
8. Organ Weights
There were no treatment-related changes in any of the organ weights taken at necropsy. A statistically significant alteration in liver (absolute and/or relative to body weight) weights was noted in Group 2 or 4 females. Mean relative lung weight (brain) was also statistically elevated in the group 3 females. These changes were considered to be incidental and unrelated to treatment based upon the lack of a dose-response relationship, absence of a similar effect in males, and no correlating biochemical or pathological changes.
9. Gross Pathology
No gross tissue alterations attributable to Ametryn were observed in any of the rabbits at necropsy. Gross lesions observed were considered to be spontaneous and/or incidental because of the absence of a dose-response and similarity to findings commonly encountered in this species.
10. Microscopic Pathology
Microscopic evaluations did not reveal any treatment-related findings.
Applicant's summary and conclusion
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.
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