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EC number: 500-038-2 | CAS number: 25322-68-3 1 - 4.5 moles ethoxylated
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from a secondary source.
Data source
Reference
- Reference Type:
- other: Secondary Literature
- Title:
- Final Report on the Safety Assessment of Triethylene Glycol and PEG-4
- Year:
- 2 006
- Bibliographic source:
- International Journal of Toxicology, 25 (Suppl. 2):121–138, 2006
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- The above experiment was performed to evaluate and assess any toxicological property of the test chemical affecting the reproductive and developmental functions of the test animals
- GLP compliance:
- not specified
- Justification for study design:
- No Data Available
Test material
- Reference substance name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- EC Number:
- 500-038-2
- EC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Cas Number:
- 25322-68-3
- Molecular formula:
- (C2-H4-O)mult-H2-O
- IUPAC Name:
- Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Test material form:
- not specified
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated / Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Molecular formula (if other than submission substance): (C2-H4-O)mult-H2-O
- Molecular weight (if other than submission substance): 44.0526 g/mol
- Substance type: Organic
- Physical state: No Data Available
- Impurities (identity and concentrations): No Data Available
Constituent 1
- Specific details on test material used for the study:
- Details on test material
- Name of test material (as cited in study report): Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated / Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated
- Molecular formula (if other than submission substance): (C2-H4-O)mult-H2-O
- Molecular weight (if other than submission substance): 44.0526 g/mol
- Substance type: Organic
- Physical state: No Data Available
- Impurities (identity and concentrations): No Data Available
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on species / strain selection:
- No Data Available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No Data Available
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- No Data Available
- Details on mating procedure:
- -Case 1: 1:2; Case 2: 1:10
Beginning 24 h after the last PEG-4 exposure, the males were mated with two naive (nontreated) virgin females. When those females showed evidence of copulation, they were replaced with two more females, until each male had mated with 10 females.
- Length of cohabitation: 10 weeks - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Duration of treatment / exposure:
- Males were dosed with the test chemical for 5 consecutive days. Female rats were exposed for 10 weeks.
- Frequency of treatment:
- No Data Available
- Details on study schedule:
- Deatils on study schedule
- F1 parental animals not mated until [...] weeks after selected from the F1 litters.
- Selection of parents from F1 generation when pups were [...] days of age.
- Age at mating of the mated animals in the study: [...] weeks: No Data Available
Dose Concentration: 0, 5000, 25,000, or 50,000 Ppm
No of animals per sex per dose: 20 animals per dose group.
Details of controls animals: No Data Available
Doses / concentrations
- Remarks:
- 0 ppm (0 mg/kg bw), 5000 ppm (425 ± 45 mg/kg), 25,000 ppm (2441 ± 328 mg/kg), or 50,000 ppm (5699 ± 1341 mg/kg)
- No. of animals per sex per dose:
- 20 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data Available
- Positive control:
- A concurrent positive control group of males receiving an i.p. injection of 0.5 mg/kg triethylenemelamine (TEM).
Examinations
- Parental animals: Observations and examinations:
- No Data Available
- Oestrous cyclicity (parental animals):
- No Data Available
- Sperm parameters (parental animals):
- No Data Available
- Litter observations:
- No Data Available
- Postmortem examinations (parental animals):
- At the end of the 10th week after the test chemical exposure, males were killed for necropsy. The females were observed and killed on gestation day 15, at which time corpora lutea and implantation sites (resorptions and live embryos) were counted.
- Postmortem examinations (offspring):
- No Data Available
- Statistics:
- No Data Available
- Reproductive indices:
- Implantation Index, Resorption Index, Mating Index.
- Offspring viability indices:
- No Data Available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Reproductive parameters, including number of fertile males and number of gravid females with viable implants, were not affected by the test chemical treatment.
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- < 5 699 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- gross pathology
- histopathology: non-neoplastic
- reproductive performance
- Remarks on result:
- other:
- Remarks:
- Not Speciifed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: Not Specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Effect levels (F1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- no
- System:
- other: Not Specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on all the observation, and all the results it was concluded that the NOAEL for the test chemical was found to be 5699 ± 1341 mg/kg.
- Executive summary:
This study was performed to evaluate and assess the effects of the test chemical on the reproductive health of the test animals. In this study, the male Fischer 344 rats were exposed to 0, 5000, 25,000, or 50,000 ppm test chemical in drinking water for 5 consecutive days in a dominant lethal assay, wherein 20 rats per group were included for the study. The respective daily consumption levels of the three doses of the test chemical were 425 ± 45, 2441 ± 328, and 5699 ± 1341 mg/kg. At the end of the 5-day dosing period, the test chemical mixed in drinking water was replaced with regular water. Beginning 24 h after the last test chemical exposure, the males were mated with two naive (non treated) virgin females. When those females showed evidence of copulation, they were replaced with two more females, until each male had mated with 10 females or until 10 weeks had passed. At the end of the 10th week after the test chemical exposure, males were killed for necropsy (observations of male toxicity are described in Short-Term Toxicity earlier in this report). The females were observed and killed on gestation day 15, at which time corpora lutea and implantation sites (resorptions and live embryos) were counted. Reproductive parameters, including number of fertile males and number of gravid females with viable implants, were not affected by test chemical treatment. There were no significant preimplantation losses or dominant lethal effects observed. A concurrent positive control group of males receiving an i.p. injection of 0.5 mg/kg of the positive control were bred with naïve females in a similar manner described above. The positive control group showed increased pre- and postimplantation loss, increased early resorptions, and significant dominant lethal effect.
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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