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EC number: 406-080-7 | CAS number: 83016-70-0 JEFFCAT ZF-10; TEXACAT ZF-10
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05 to 2012-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Test item: JEFFCAT ZF-10
- Chemical name: N,N,N'-Trimethyl-N'-hydroxyethyl-bis-aminoethyl ether
- Batch number: 1K703
- CAS number 83016-70-0
BIOAGRI code: AGR-1892/11
- Physical state: liquid
- Sample arrival date in BIOAGRI-DF: 28/Dec/2012
- Sample storage: in a specific room (Test Item Storage Room), at room temperature, protected from humidity and light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
a) Species: rat (Rattus norvegicus)
b) Strain: Wistar Hannover
c) Source: BIOAGRI Laboratórios – DF/ Brazil
d) Sex: Males and females (nulliparous and non-pregnant)
e) Age (on the first day of dosing): 8 to 9 weeks old
f) Number of animals on study: 10 animals/sex/group.
- Weight : 286.0g +/- 14.2g for males and 184.4g +/- 8.2g for females after randomization
- Fasting period before study: yes
- Housing: polypropylene rodent cages (41x34x19 cm) with wire mesh tops and wood shavings as bedding material.
- Diet (e.g. ad libitum): Nuvilab CR-1 diet for rodents by Nuvital Nutrientes Ltda, Curitiba –PR, Brazil, available ad libitum
- Water (e.g. ad libitum): Filtered drinking water was supplied by CAESB (Companhia de Saneamento Ambiental do Distrito Federal) in water bottles and was available ad libitum.
- Acclimation period: minimum of 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 °C - 23.2 °C
- Humidity (%): 44.0% -70.0%
- Air changes (per hr): 10-20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized water
- Details on oral exposure:
- Daily, by oral gavage, at approximately the same time of the day, on a 7-day-a-week-basis, for a period of 13 weeks, in a constant dosage volume of 10 mL/kg.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 mg/kg bw/day (nominal)
- Remarks:
- Basis: nominal in deionized water
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Remarks:
- Basis: nominal in deionized water
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- Basis: nominal in deionized water
- No. of animals per sex per dose:
- 10 animals/sex/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- All animals were randomized and observations were performed in a “blinded” study design.
Examinations
- Observations and examinations performed and frequency:
- Animals were checked twice daily for mortality or morbidity on working days and once daily on Saturdays, Sundays and public holidays.
They were subjected to a careful clinical examination before the initiation of the treatment and once a week during the dosing period.
Body weight and food consumption were recorded once a week during the study period.
An ophthalmoscopic examination was performed on all animals prior to the initiation of dosing and at the end of treatment period.
A neurotoxicological evaluation using a Functional Observation Battery was performed during study week 13.
At the end of the study, urine was collected after an overnight fasting period and urinalysis parameters were examined. Blood samples were collected for hematology, leukogram, clotting and clinical chemistry analyses. - Sacrifice and pathology:
- A complete gross examination was performed on all animals after euthanasia by carbon dioxide inhalation.
At study termination, the animals were subjected to a gross examination and the appropriate organs/tissues were removed, weighed and processed for histopathological evaluation. Histopathological slides obtained from the control and high dose groups were evaluated microscopically, plus two males with macroscopic lesions (stomach and urinary bladder) at mid dose and two females at low (liver) and mid dose (ovary). - Statistics:
- Quantitative variables such mean body weight and mean body weight change, food consumption, FOB, hematological assessment (hemogram, leukogram, clotting time and biochemistry) were analyzed by One-Way Analysis of Variance (ANOVA), followed by Dunnett’s test if significance is detected and mean body weight change, food consumption, FOB and hematological assessment (hemogram, leukogram, urinalysis and biochemistry), followed by Mann-Whitney U test if
significance is detected. For qualitative or non-parametric data such as urinalysis, macroscopic and microscopic findings comparison was carried out using the Chi-Square Test. The level of significance was set at 5% and the statistical program used was SAS Software (SAS Institute Inc., Cary, NC).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The test item induced no clinical signs of toxicity.
- Mortality:
- no mortality observed
- Description (incidence):
- The test item induced no mortality.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Effects on body weight or body weight gain were not observed during this study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Effects on food consumption were not observed during this study.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There were no significant findings in the hematological, leukogram and coagulation parameters.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- There were no significant findings in the clinical chemistry parameters.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- There were no significant findings in the urinalysis parameters.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were no significant findings in the Functional Observation Battery.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Pathological changes of toxicological interest were not observed.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Pathological changes of toxicological interest were not observed.
- Neuropathological findings:
- no effects observed
- Description (incidence and severity):
- There were no significant findings in the Functional Observation Battery.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Pathological changes of toxicological interest were not observed.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results obtained in the repeated dose 13 week oral toxicity study, the NOAEL (No Observed Adverse Effect Level) of the test substance was considered to be greater than 100 mg/kg/day in males and female Wistar rats.
This test was requested by the National Competent Authority in accordance with Article 16(1) of Directive 67/548/EEC.
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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