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EC number: 402-600-1 | CAS number: 765-12-8
- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP; guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Details on test material:
- purity: 99.6 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- In general, each of the male and female animals (F0 and F1 generation) was mated overnight at a 1 : 1 ratio for a maximum of 2 weeks. Generally, throughout the mating period, each female animal was paired with a predetermined male animal from the same dose group. Matings occurred by placing the female in the cage of the male mating partner from about 4.00 p.m. until 7.00 - 9.00 a.m. of the following morning. Deviations from the specified times were possible on weekends and public holidays and were reported in the raw data.
A vaginal smear was prepared after each mating and examined for sperm. lt sperm was detected, pairing of the animals was discontinued. The day on which sperm were detected was denoted "day 0" and the following day "day 1" p.c. (post coitum). - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analyses mentioned were carried out at the Analytical Chemistry Laboratory of Experimental Toxicology and Ecology, BASF Aktiengesellschaft, Germany. Analytical verifications of the stability of the test substance in doubly distilled water for a period of 8 days deep frozen at -20 0C were carried out before the study was initiated.
- Duration of treatment / exposure:
- F0: 20 weeks
F1: 19 weeks - Frequency of treatment:
- once a day
- Details on study schedule:
- F0 generation animals and their progeny
The 100 male and 100 female animais required for the study were 35 (j± 1) days old at the
beginning of treatment, and their mean weights and weight ranges were:
-male animals: 117.0 (101.2 - 135.9) g
-female animals: 93.4 ( 79.8 - 105.7) g
The assignment of the animais to the different test groups was carried out using a randomization program, according to their weight four days before the beginning of the administration period (day -4).
After the acclimatization period, the F0 generation parental animais continuously received the test substance at the appropriated doses of 0; 100; 300 or 1,000 mg/kg body weightlday orally (by gavage) once a day always at approximately the same time of day (in the morning) until one day before they were sacrificed. The calculation of the volume administered was based on the last individual body weight. At least 75 days after the beginning of treatment, males and females from the same dose group were generally mated at a ratio of 1 : 1. The females were allowed to litter and rear their pups (F1 generation pups) until day 4 (standardization) or 21 after parturition. After weaning of F1 pups the F0 generation parental animals were sacrificed.
F1 generation parental animals and their progeny
After weaning, 25 males and 25 females of the F1 pups of test groups 00, 01, 02, and 03 (0; 100; 300 and 1,000 mg/kg bw/day) were taken per group as the basis of the F1 generation parental animals. These animals were chosen by lot during rearing; it was attempted to take each litter into account. If fewer than 25 litters in these groups were available for selection or if one sex was missing in a litter, more animals were taken from different litters from the relevant test group to give the full number. All selected animals were treated with the test substance at the same dose level as their parents from their growth into adulthood up to about one day before they were sacrificed. At least 75 days after assignment of the F1 generation parental animais, the males and females were mated at a ratio of 1 :1. The partners were randomly assigned to one another. Matings between siblings were, however, avoided. The females were allowed to litter and rear their pups (F2 generation pups) until day 4 (standardization) or 21 after parturition. The F1 generation parental animals were sacrificed after the F2 generation pups had been weaned.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 100; 300 and 1000 mg/kg body weight/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- mortality; littering and lactation behavior; food consumption; body weight data
- Oestrous cyclicity (parental animals):
- Estrous cycle length and normality were evaluated daily for all F0 and F1 female parental rats for a minimum of 3 weeks prior to mating and were continued throughout the mating period until the female exhibited evidence of mating. Moreover, at necropsy a vaginal smear was examined to determine the stage of the estrous cycle for each F0 and FI female with scheduled sacrifice.
- Sperm parameters (parental animals):
- sperm motility, sperm morphology, sperm head count (cauda epididymis), sperm head count (testis)
(Sperm morphology and sperm head count (cauda epididymis and testis) were evaluated for the control and highest dose group, only) - Litter observations:
- pup number and status at delivery, pup viability/mortality, sex ratio, pup clinical observations, pup body weight data, pup organ weights
- Postmortem examinations (offspring):
- All pups with scheduled sacrifice (i.e. pups, which were culled on day 4 p.p., and pups, which were sacrificed on day 21 after birth or subsequent days) were killed by means of CO2. These pups were examined externally and eviscerated; their organs were assessed macroscopically. All stillborn pups and all pups that died up to weaning were examined externally, eviscerated and their organs were assessed macroscopically. If there were notable findings or if abnormalities were found in the daily clinical observation of the animais after their delivery, the affected animais were, if lt was deemed necessary, examined additionatly using appropriate methods (e.g., skeletal staining according to a modified method of KIMMEL and TRAMMELL (Kimmel, C.A. and Trammell C., 1981)).
The stained skeletons were evaluated under a stereomicroscope or a magnifying glass. All pups without any notable findings or abnormalities were discarded after their macroscopic evaluation.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- salivation, unsteady gait
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- chronic nephropathy in males of the high dose group
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: fertility and reproductive performance
- Remarks on result:
- other: Generation: F0 and F1 (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: Generation: F1 and F2 (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: general toxicity
- Remarks on result:
- other: Generation: F0 and F1 (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this 2-generation reproduction toxicity study there were no indications that the administration of Triethylenglykoldivinylether adversely affected reproductive performance or fertility of the F0 or F1 parental animals up to and including a dose of 1,000 mg/kg body weight/day. No test substance induced signs of developmental toxicity occurred in the progeny of the F0 or F1 parents up to and including 1,000 mg/kg body weight/day. The examinations of the F0 and F1 parental rats for general signs of toxicity revealed some substance-related effects at the high dose (1,000 mg/kg body weight/day).
- Executive summary:
Under the conditions of this 2-generation reproduction toxicity study there were no indications from the clinical examinations, sperm evaluations and gross and histopathology, that the administration of Triethylenglykoldivinylether adversely affected reproductive performance or fertility of the F0 or F1 parental animals up to and including a dose of 1,000 mg/kg body weight/day. Estrous cycle data, mating behavior, conception, gestation, parturition, lactation and weaning as well as sperm parameters, sexual organ weights and gross and histopathological findings of these organs (including differential ovarian follicle counts in the F1 females) were not affected by the test substance administration. The examinations of the F0 and F1 parental rats for general signs of toxicity revealed some substance-related effects at the high dose (1,000 mg/kg body weight/day). These were substantiated by unsteady gait and/or abdominal position, which occurred intermittently in several, but not all top dose rats shortly after gavage dosing and persisted only for some minutes. Moreover, absolute and relative kidney weights were statistically significantly increased in high dose F0 and F1 males and showed corroborative histopathological findings (i.e. increased incidence of chronic progressive nephropathy). No test substance induced signs of developmental toxicity occurred in the progeny of the F0 or F1 parents up to and including 1,000 mg/kg body weight/day. The test substance did not influence the number of delivered F1 and F2 pups/litter, the sex ratio, the postnatal survival, the pup body weights or the sexual maturation of the F1 progeny. Clinical and/or gross necropsy examinations of the F1 and F2 pups revealed only findings that were considered to be spontaneous in nature, due to their scattered occurrence without any relation to dose. Thus, the NOAEL (no observed adverse effect level) for fertility and reproductive performance is 1,000 mg/kg body weight/day. The NOAEL for overall general toxicity on the parental rats could be fixed at 300 mg/kg body weight/day. The NOAEL for pre- and postnatal developmental toxicity (growth and development of the offspring) is 1,000 mg/kg body weight/day.
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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