Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 204-535-2 | CAS number: 122-34-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines of May 1981
- Principles of method if other than guideline:
- At the end of the study, an additional 10 male and 10 female animals per test group were given the standard diet for a period of 30 days. This was to assess whether any observed effects were reversible or any late effects could occur.
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Simazine
- EC Number:
- 204-535-2
- EC Name:
- Simazine
- Cas Number:
- 122-34-9
- Molecular formula:
- C7H12ClN5
- IUPAC Name:
- 6-chloro-N2,N4-diethyl-1,3,5-triazine-2,4-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Test material: Simazine Technical
- Description: White powder
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Weight at study initiation: 137 g (mean bodyweight)
- Housing: conventional single cages (Makrolon type 2)
- Diet (e.g. ad libitum): laboratory standard diet
- Water: available ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 50 - 60%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- Treated feed was available ad libitum.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 ppm
- Remarks:
- Group I
- Dose / conc.:
- 500 ppm
- Remarks:
- Group II
- Dose / conc.:
- 2 500 ppm
- Remarks:
- Group III
- No. of animals per sex per dose:
- 30 animals per sex per dose
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
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: Yes
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: Yes
OPHTHALMOSCOPIC EXAMINATION: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 50, 90 and 120 days
- Parameters examined: Leucocytes, haematocrit, haemoglobin, erythrocytes, differential haemogram
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 50, 90 and 120 days
- Parameters examined: Glucose, total albumin, GOT, GPT, γ-GT, LDH, alkaline phosphatase
URINALYSIS: Yes
- Time schedule for collection of urine: 50, 90 and 120 days
- Parameters examined: specific gravity, pH, urobilinogen, erythrocytes, bilirubin, ketone, glucose, nitrite and protein
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- 10 animals per sex per dose group were narcotised and autopsied after 50 and 90 days of treatment. After 120 days the remaining animals (10 animals per sex per dose group) were autopsied.
The following organ weights were measured: brain, heart, liver, kidneys (left and right), adrenal glands (left and right), spleen, ovaries (left and right), testicles and epididymis (left and right).
Histology was performed on the following organs of control and Group III animals after 90 days: liver, heart, kidneys (left and right), spleen, brain (cerebrum, cerebellum, medulla oblongata), thyroid glands (left and right), stomach, duodenum, colon, pancreas, hypophysis, testicles (left and right), epididymis (left and right), uterus and ovaries (left and right), adrenal glands (left and right), lung, N. ischiadicus, urinary bladder.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- After intervals (50, 90 and 120 days) means of weight changes showed clear dose related decreases during the exposure period and increased gains during the reversal period.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- After intervals (50, 90 and 120 days) means of total feed consumption showed clear dose related decreases during the exposure period.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- During the exposure period, feed efficacy of the highest dosage group was clearly diminished.
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 90 days, male animals of Groups II and III and female animals of Group III showed significantly higher values of total albumin. This was not observed at 50 and 120 days.
At 90 days, male and female animals of Group III showed significantly higher values of alkaline phosphatase. This was not observed at 50 and 120 days. - Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Female animals treated with 500 ppm showed increased organ weights of liver and kidney at 50 and 90 days.
In animals treated with 2500 ppm the following alterations occurred:
- in females, increased organ weights of liver and kidneys at 90 days and increased liver organ weights at 120 days
- males showed significantly decreased weights of testicles in the 50 and 90 days interim autopsy and in the 120 days final autopsy. - Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Degeneration of the germinal epithelium occurred in the testes of all male animals in Group III. In five cases, the lesions were so severe that regeneration was not possible as total atrophy had occurred.
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 100 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: equivalent to 8.0 mg/kg bw
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- At 100 ppm in all evaluated parameters during the treatment period of 90 days, no test specific alterations occurred. The 90 day NOEL in rats for Simazine Technical is therefore 100 ppm, which corresponds to 8.0 mg/kg bw.
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.