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Diss Factsheets
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EC number: 700-993-7 | CAS number: -
- 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)
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: subacute study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was condusted in compliance with the principles of GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol 400
- Details on oral exposure:
- The administration volume was 5 ml/kg body weight per day.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test item (test substance) was administered by gavage in Polyethylene glycol 400. The administration volume was 5 mL/kg body weight per day.
The formulations were prepared weekly. For the preparation of the formulations, a test item content of 100% was assumed for calculation. The preparation of the formulation is described in the raw data.
The stability of the formulations was analytically confirmed before the first treatment. Dosage forms for these analyses were prepared according to the procedure intended for this study. The dosage forms prepared for stability analysis were analyzed after 4 hours and 4 and 8 days thereafter. The analysis revealed that the test item was stable over 8 days within the defined limits.
The content of the test substance concentrations (control and dosed formulations) was verified twice during the study.
The test substance was administered as a solution in the vehicle. The formulations were stored at room temperature. - Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- once daily
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg bw
Basis:
actual ingested - No. of animals per sex per dose:
- five
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The dose level was selected according to results obtained in a previous oral 2-weeks dose finding toxicity study performed in rats at Bayer Pharma AG, where 0, 100, 500 or 1000 mg/kg b.w. Ester PSA + DEG were administered in polyethylene glycol 400 to 3 male and 3 female rats per dose group.The administration volume was 5 ml/kg b.w..
In-life data revealed no treatment-related changes in mortality, clinical observations, body weight gain, food intake, water intake and necropsy.
In conclusion, the NOAEL in this 2-weeks dose finding toxicity study was found to be 1000 mg/kg bw. - Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes (incl. Open Field Observations (OFO))
- Time schedule: once before start and once weekly thereafter
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION: Yes
- Time schedule for examinations: weekly
WATER CONSUMPTION: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: once, day 30, 31
- How many animals: all dose groups incl. controls
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: once, day 230, 31
- How many animals: all dose groups incl. controls
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: FOB: once, day 27-28 ); MA: once, day 27-28
- Dose groups that were examined: all dose groups incl. controls
- Battery of functions tested: Functional Observational Battery (FOB); Motor Activity (MA) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (all dose groups and controls)
ORGAN Weights:
Brain, heart, liver, spleen, kidneys (both), thymus, adrenal glands (both), epididymides (both), testes (both), prostate, seminal vesicles with coagulation glands, ovaries/oviducts (both) and uterus/cervix.
Fixed organs:
Adrenals, aorta, brain (cerebrum, cerebellum, ponslmedulla), epididymides, esophagus, eyes, eyelids, extraorbital lachrymal glands, femur, harderian glands, head (with nasal and paranasal cavities), heart, intestine (duodenum, jejunum, ileum, cecum, colon, rectum and remaining intestine), kidneys, larynx, liver, lymph nodes (mandibular, bronchial/hilus, and mesenteric), lung, mamma, optical nerves, ovaries, oviducts, pancreas, pharynx, pituitary, prostate, salivary glands, sciatic nerve, seminal vesicles (incl. coagulating glands), skeletal muscle (thigh), skin (mammary and muzzle), spinal cord (cervical, thoracic, lumbar), spleen, sternum, stomach (forestomach and glandular stomach), testes, thymus, thyroids (including parathyroid glands), tongue, trachea, ureter, urethra, urinary bladder, uterus with uterine cervix, vagina, Zymbal’s glands and all organs or tissues with macroscopic findings.
HISTOPATHOLOGY: Yes (high dose group and controls)
- Microscopic: Adrenals, aorta, brain (cerebrum, cerebellum, brain stem), epididymides, eyes, femur, heart, intestine (duodenum, jejunum, ileum, cecum, colon, rectum and remaining intestine), kidneys, lung, ovaries, oviducts, prostate, sciatic nerve, skeletal muscle (thigh), spinal cord (cervical, thoracic, lumbar), sternum with bone marrow, testes, seminal vesicles (incl. coagulating glands), stomach, trachea and thyroids glands, urinary bladder, uterus with uterine cervix, vagina and all organs or tissues with macroscopic findings.
HISTOPATHOLOGY: Yes (all dose groups and controls)
-Microscopic: thyroids - Statistics:
- Statistical tests on FOB, body weights and weight gain as well as on absolute organ weights were done using the Dunnett Exact Homogeneous Test. For relative organ weights the Dunnett Exact Homogeneous Test after log. Transformation was used.
If primary food and water intake data were recorded, the calculated food/water intake per animal was evaluated using adjusted Mann-Whitney U-tests.
The Dunnett Exact Homogeneous or Heterogeneous Test, the Dunnett Exact Homogeneous Test after log. Transformation or the Bonferroni/Mann-Whitney U-test was used for clinical pathology parameters. Descriptive statistics were provided per sex, dose group and time point for all parameters that were recorded with a specified unit. This included measures of general tendency (mean and median (median not given for food and water intake)) and general variability (standard deviation, minimum and maximum) as appropriate. - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- FOOD INTAKE:
A minimal statistically significant increase of food intake was observed in females starting at the dose of 100 mg/kg b.w., but not found to be of any toxicological relevance.
The minimal statistically significant decrease observed in males at the dose of 1000 mg/kg b.w. was too small and too inconsistent to be of toxicological relevance.
WATER INTAKE:
A statistically significant decrease of water intake was observed in females at the dose of 1000 mg/kg b.w.. As this decrease very small, it was not found to be of any toxicological relevance. Other statistically significant changes of water intake observed were too small and/or too inconsistent to be of toxicological relevance.
ORGAN WEIGHTS:
At the high dose of 1000 mg/kg b.w., relative ovaries weights were statistically increased and the same trend could be observed in absolute ovaries weights at the high dose (not statistically significant). As histopathology did not reveal an effect on ovaries, this is not regarded as an adverse effect.
HAEMATOLOGY:
Hematological investigations on red blood parameters revealed a statistically significant decrease in hemoglobin concentration (HB) and hematocrit (HCT) in males at the dose of 1000 mg/kg b.w.. As these effects were only slight and based on the much lower values of one single animal (No. 19) these findings were not found to be of any toxicological relevance. Additionally a slight increase of thrombocyte count could be observed in both sexes at the dose of 1000 mg/kg b.w., being only statistically significant in males.
CLINICAL CHEMISTRY in the BLOOD:
Creatinine (CREA) was significantly decreased in males at the doses of 100 and 1000 mg/kg b.w. and a decrease in total bilirubin (Bili-t) in females at the doses of 100 and 1000 mg/kg b.w. was observed. These findings were considered of no toxicological relevance, as a dose-relationship was missing. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No test item related effects on the parameter investigated
- Critical effects observed:
- no
- Executive summary:
In a repeated dose oral toxicity study in rats (Wistar, OECD TG 407), the substance was adimistered via gavage to 5 rats/sex/dose at 0, 100, 300, 1000 mg/kg bw in PEG 400 for 4 weeks. Up to and including 1000 mg/kg bw no mortality occured. The behavior and clinical appearance of the rats were not influenced by the treatment up to and including 1000 mg/kg in both sexes. The body weight gain, the food, water intake, clinical chemistry, hematology and organ weights were not affected up to and including 1000 mg/kg in males and females. The results from Functional Observational Battery (FOB) measurements in males and females receiving up to and including 1000 mg/kg bw did not differ from the control animals. Motor and Locomotor Activity (MA/LMA) tests did not indicate neurotoxicity up to and including 1000 mg/kg. There was no toxicological relevant effect on organ weights observed and histopathological investigations revealed no test item-related changes up to and including 1000 mg/kg b.w. in both sexes.
Therefore, under the condition of the present study, the NOAEL (no-observed-adverse-effect-level) for the test item after 4-week daily oral treatment by gavage is 1000 mg/kg b.w. for male and female rats.
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:
- other: OECD TG 407
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2-hydroxyethoxy)ethan-1-ol; 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid
- EC Number:
- 700-993-7
- Molecular formula:
- C12H14O6.C4H10O3
- IUPAC Name:
- 2-(2-hydroxyethoxy)ethan-1-ol; 2-{[2-(2-hydroxyethoxy)ethoxy]carbonyl}benzoic acid
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PEG 400
- Details on mating procedure:
- not applicable because it is a subacute study
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw and day
Basis:
other: actual dose received
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: adverse effects on reproductive organs or tissues
- Remarks on result:
- other: Generation: not applicable because it is a subacute study (migrated information)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effects on reproductive organs or tissues were observed in a subacute oral study with rats up to and including 1000 mg/kg and 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.
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