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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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-06 to 2013-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Experimental test run under GLP conditions and according to OECD Guidelines with no deviations identified. Study conducted in an AAALAC – Accredited Test Facility in conformity with the applicable rules for animal welfare and humane use and care of laboratory animals.
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 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Test substance: JEFFCAT ZF-10
Chemical name (IUPAC): N,N,N'-Trimethyl-N'-hydroxyethyl-bis-aminoethyl ether
CAS number: 83016-70-0
BIOAGRI code: AGR-1892/11
Sample arrival date: 28/Dec/2011
Batch number: IK703
Expiration date: 18/Jun/2013
Storage: stored 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’s breeding house
d) Sex: males and females (nulliparous and non-pregnant)
e) Age at starting of dosing: 7 to 8 weeks old
f) Number of animals: 13 males/group and 26 females/group.
- Weight at study initiation: no details
- Fasting period before study: yes
- Housing: polypropylene cages (41x34x19 cm) with wire mesh tops and bedding material (wood shavings)
- Diet (e.g. ad libitum): Nuvilab CR-1 diet for rats supplied by Nuvital Nutrientes Ltda. available ad libitum
- Water (e.g. ad libitum): filtered drinking water was autoclaved. Water was supplied by CAESB (Companhia de Saneamento Ambiental do Distrito
Federal)
- Acclimation period: 3 males/cage and up to 2 females/cage examined and acclimated for minimum 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6 – 24°C
- Humidity (%): 42.5 – 69.6%
- 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:
- water
- Remarks:
- deionized
- Details on exposure:
- Dosing began 70 days before mating for males and 14 days for females and continued until the day prior to necropsy (after twenty-one days of
lactation for females and at the end of the mating period for males). - Details on mating procedure:
- Premating :
At the end of acclimation period, animals were randomly assigned to the experimental groups, housed (up to 3 males/cage and up to 2 females/cage) and the treatment began.
Mating :
After a premating period of 70 days for males and 14 days for females, two females were cohabited with an assigned male (2 female: 1 male) from the same dose level until evidence of copulation was observed, or 3 weeks had elapsed. Care was taken to avoid sibling mating. Vaginal smears were collected daily during mating period and examined for the presence of sperm. Day 0 of gestation was defined as the day a sperm is found in the vaginal smear. Female No 10 (control group) that showed no evidence of copulation at the end of the mating period (3 weeks) was placed with a second male at the same group and mating was confirmed 2 days later. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Parental animals (males) were treated 70 days before mating and until the end of the mating period.
Male animals were dosed for a total of 94 days.
For females, this included 14 days prior to mating, during the mating period (up to 4 weeks), during gestation and up to lactation day 20, for a total of 41 to 80 days. - Frequency of treatment:
- Daily, by gavage, on a 7-day-week-basis.
The volume administered each day was 4 mL/kg body weight.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Remarks:
- In deionized water
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- In deionized water
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- In deionized water
- No. of animals per sex per dose:
- 3 groups of 13 male and 26 female rats per dose
Control group of 13 males and 26 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - dose level selection: the dosage levels were selected following consultation with the Sponsor on the basis of the results of previous testing with the test substance. The following doses were chosen for this study:
* 10 mg/kg bw/day as the expected dose which causes no signs
* 50 mg/kg bw/day as the intermediate dose level
* 100 mg/kg bw/day as the expected dose which causes signs of systemic toxicity, but not death or severe suffering
Test group Dose Concentration Number of animals Animal identification
(mg/Kg/day) (mg/mL) Male Female Male Female
1 Vehicle (a) 0 13 26 105-117 1-26
2 10 (b) 2,5 13 26 118-130 27-52
3 50 (b) 12,5 13 26 131-143 53-78
4 100 (b) 25 13 26 144-156 79-104
(a) Vehicle (deionized water).
(b) test substance (Test Solutions).
Examinations
- Parental animals: Observations and examinations:
- Throughout the treatment period, each animal was observed at least once daily for mortality, morbidity, pertinent behavioral changes, signs of difficult or prolonged parturition, and all signs of overt toxicity through cage side observations. At least once weekly throughout the treatment period (except during mating and gestation), each animal was handled and examined for signs of ill health or reaction to treatment, abnormal behavior or appearance.
- Litter observations:
- Litters were weighed on days 0 and 4 (before standardization) and after standardization on days 7 and 14. Live pups were weighed individually after standardization on day 21.
- Postmortem examinations (parental animals):
- All animals were euthanized by CO2 inhalation:
- Males: until the end of mating period;
- Females: from day 21 post-partum;
- Females which have not delivered at day 25 post-coitum: From day 25 post-coitum.
At termination, all parental animals were examined macroscopically for any abnormalities or pathological changes, with special attention paid to the organs of the reproductive system. - Postmortem examinations (offspring):
- All animals were euthanized by CO2 inhalation:
- Surviving pups: on day 4 of lactation which were eliminated after standardization: From day 4 post-partum;
- Surviving pups: from day 21 post-partum.
Dead pups and pups euthanized at day 4 were necropsied for macroscopic evaluation, preserved and studied for possible defects. - Statistics:
- Quantitative variables such as body weights, food consumption, number of fetuses and corpora lutea were analyzed by One Way Analysis of Variance (ANOVA), followed by Dunnett’s test if significance was detected, or by non-parametric test of Kruskal-Wallis, according to the results of tests for normality and homogeneity of variance. The Chi-Square Test was used for statistical evaluation of clinical findings, macroscopic and microscopic findings and loss of offspring. 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: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Test substance did not cause clinical signs.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- Test substance did not cause mortality.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on body weight, body weight gain were observed.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect on food consumption was observed.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- There were no microscopic alterations that could be attributed to the test item.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- The male and female mating indices were 100% in all groups, as were the male fertility index and the gestation index. However, the female fertility index was lower than male, although it was similar across all groups.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- parental toxicity
- Effect level:
- > 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- > 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were observed in pups through day 21 postnatal.
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No test item related pup mortality occurred.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Statistically significant lower mean body weight in pups from dams exposed to 10 mg/kg/day. difference was very slight in magnitude and occurred in the low dose level, it was considered to be incidental.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- The necropsy evaluation did not reveal treatment related findings in pups.
- Histopathological findings:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Despite that this finding was observed at the high dose level, it was not considered to be treatment related because was an isolated finding and occurred in very slight magnitude.
In the reflex evaluation of the pups, no important alteration occurred in treated males or females compared to the control group. Only numerical differences were found and considered as normal biological variations, even in the statistically significant observations which were not dose
proportional.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- embryofetal toxicity
- Generation:
- F1
- 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 (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
Test substance did not cause mortality or clinical signs of toxicity during the study. No effects on body weight, body weight gain or food consumption were observed. No treatment related macroscopic changes were noted in male or female rats. There were no microscopic alterations that could be attributed to the test item. None of the mating, gestation or lactation parameters were considered to have been affected by treatment with the test item. No biologically significant differences were found between the numbers of live or dead pups from treated and control dams during whole treatment period. No clinical signs were observed in pups through day 21 postnatal. No test item related pup mortality occurred. The mean body weight of pups on days 0, 4, 7, 14 and 21 postnatal were similar in all groups. Physical and reflex evaluation of male and female pups did not reveal effects of test item administration in the different groups. The necropsy evaluation did not reveal treatment related findings in pups.
Applicant's summary and conclusion
- Conclusions:
- In the experimental conditions of this one generation reproduction toxicity study, the No Observed Adverse Effect Level (NOAEL) of the test item test substance in Wistar rats was considered to be greater than 100 mg/kg/day for males and females and greater than 100 mg/kg/day for maternal-embryo-fetal toxicity.
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.
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