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EC number: 205-592-6 | CAS number: 143-22-6
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reasonably well-documented study which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Triethylene glycol ethers: Evaluation of in vitro absorption through human epidermis, 21 day dermal toxicity in rabbits and a developmental screen in rats
- Author:
- Leber AP, Scott RC, Hodge MCE, Johnson D, Krasavage WJ
- Year:
- 1 990
- Bibliographic source:
- J Am Coll Toxico, 9 (5) 507-15
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Chernoff-Kavlock assay
- Deviations:
- yes
- Remarks:
- modified for use with rats rather than mice
- Principles of method if other than guideline:
- The modified assay has also been shown to respond to known teratogens by a variety of routes of administration and has been verified by NIOSH (Schuler) and in the testing laboratory itself.
- GLP compliance:
- not specified
- Remarks:
- Study was subject to quality control procedures.
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(2-(2-butoxyethoxy)ethoxy)ethanol
- EC Number:
- 205-592-6
- EC Name:
- 2-(2-(2-butoxyethoxy)ethoxy)ethanol
- Cas Number:
- 143-22-6
- Molecular formula:
- C10H22O4
- IUPAC Name:
- 2-[2-(2-butoxyethoxy)ethoxy]ethanol
- Details on test material:
- - Name of test material (as cited in study report): triethylene glycol monobutyl ether (TEGBE)
- Physical state: Clear, colorless liquid
- Analytical purity: 99.9+%
- Other: Source: Olin Corporation, New Haven, Connecticut, USA
Constituent 1
- Specific details on test material used for the study:
- Source: Olin Corporation, New Haven, Connecticut, USA.
Purity: 99.9%.
Storage temp: 20C.
Note: Impurities not specified but likely to be higher oligomers of series such as tetraethylene glycol butyl ether.
Test animals
- Species:
- rat
- Strain:
- other: Alpk: AP (Wistar-derived)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Specific Pathogen Free colony, maintained at the Animal Breeding Unit, Imperial Chemical Industries PLC, Alderley Park, UK
- Age at study initiation: 11 - 13 weeks of age
- Weight at study initiation: 210 - 305 g
- Housing: individually; stainless steel mesh bottom floor polypropylene cages until GD18 then in solid bottom cages with paper bedding from GD18 for nesting. Bedding not then changed until end of study to avoid disturbance of litter.
- Diet and water: commercial rodent diet (Special Diet Services, Witham, UK) and water (filtered and sterilised tap water) ad libitum. Analysis of water performed to check for impurities.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 43-63
- Air changes (per hr): 15-25
- Photoperiod (hrs dark / hrs light): 12/12.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionised water
- Details on exposure:
- Test material was administered in deionised water at a dosing volume of 10ml/kg bodyweight (lml/100g).
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- Proof of pregnancy: sperm in vaginal smear - taken as day 1.
- Pregnant animals delivered to test laboratory over a 3 day period. No further information - Duration of treatment / exposure:
- Days 7 - 16 of gestation inclusive.
- Frequency of treatment:
- Once daily at the same time each day.
- Duration of test:
- Maternal animals and offspring were sacrificed on day 5 post partum.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The maximum dose levels of TEGBE was selected base on the maximum recommended in OECD and EPA guidelines
- Random allocation of animals to cages and treatment groups.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: Day 1 and subsequent weights recorded on Days 7 - 17, 19 and 22 of gestation and on Day 5 post partum. - Ovaries and uterine content:
- The uteri of females which failed to litter were grossly examined for implantation sites on or shortly after Day 25 of gestation to ascertain if the animals had been pregnant.
- Indices:
- Litter data collected on post partum days 1 (within 24 hours) and 5: viability, sex, number, litter weight.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No significant changes in clinical condition were seen throughout the study in females treated with TEGBE. No maternal mortality was observed in the study. Slight maternal toxicity was observed in both EGME groups (increased incidence of piloerection) and in the top dose group, several instances of vaginal bleeding between Days 17 and 19 of gestation were recorded, this condition is often observed with foetal resorption.
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- not examined
- Skeletal malformations:
- not examined
- Visceral malformations:
- not examined
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There were no effects on the litter parameters measured in the TEGBE-treated groups at either the 250 mg/kg or 1000 mg/kg dose levels.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Administration of the positive control (methoxyethanol - EGME) produced complete resorption of all embryos at both dose levels and there are signs that EGME may have produced slight maternal toxicity at both dose levels.
Applicant's summary and conclusion
- Conclusions:
- At the dose levels tested (250 or 1000mg/kg/day), 2-(2-(2-butoxyethoxy)ethoxy)ethanol showed no foetotoxic or teratogenic potential and exhibited no maternal toxicity.
- Executive summary:
In a GLP developmental toxicity screening study in rats, the test substance when administered by gavage on gestation days 7 -16 at doses of 250 or 1000 mg/kg/day showed no foetotoxic or teratogenic potential and exhibited no maternal toxicity. Based on the criteria of the screening protocol this substance would not be deemed to have developmental toxicity potential.
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