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Registration Dossier
Diss Factsheets
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EC number: 203-933-3 | CAS number: 112-07-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented publication which meets basic scientific principles. Glycol ether acetates are rapidly hydrolysed in vivo to the parent glycol ethers by plasma esterases and will show the same systemic toxicity profile as the parent glycol ether. Data here reported here is for developmental toxicity of 2-butoxyethanol. Full details of the justification for the use of an analogue for this end point are included in the document appended to chapter 13 of this dossier.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenic evaluation of ethylene glycol monobutyl ether in Fischer 344 rats and new zealand white rabbits following inhalation exposure.
- Author:
- Tyl RW, Millicovsky G, Dodd DE, Pritts I, France KA and Fisher LC
- Year:
- 1 984
- Bibliographic source:
- Env. Health Perspect., 57, p47-68.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-butoxyethanol
- EC Number:
- 203-905-0
- EC Name:
- 2-butoxyethanol
- Cas Number:
- 111-76-2
- Molecular formula:
- C6H14O2
- IUPAC Name:
- 2-butoxyethanol
- Details on test material:
- - Name of test material (as cited in study report):
- Source: Union Carbide Corporation
- Lot #45-235
- Analytical purity: 99.6 %, verified.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Dutchland Labs, Denver
- Weight at study initiation: 4kg approx
- Housing: individually in stainless steel wire mesh cages
- Diet (ad libitum except during exposure): Big red rabbit food, Agway Inc
- Water (ad libitum except during exposure): tap
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Photoperiod (hrs dark / hrs light): Controlled and monitored but not specified.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Glass and stainless steel 2.1x1x2.1(h)m, volume 4350l.
- Method of holding animals in test chamber: no restraint
- Air change rate: 14/hr
- Temperature, humidity, pressure in air chamber: measured 4x per exposure: temp 75.7-80.9F, humidity 33.9-49%
- System of generating vapour: Liquid metered from a piston pump into a heated glass evaporator. Temperature maintained at minimum required to vapourise liquid. Vapour carried to exposure chamber by conditioned air. Expected chamber concentration reached within 20mins of start of experiment.
- Treatment of exhaust air: filtered.
TEST ATMOSPHERE
- Brief description of analytical method used: GC with FID calibrated over expected concentration range. Sampling once per hour.
- Samples taken from breathing zone: yes. Vapour concentrations in breathing zone found variation of 1% - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC with FID calibrated over expected concentration range. Sampling once per hour.
- Details on mating procedure:
- Bred using in house breeding colony males. Date of copulation designated GD0
- Duration of treatment / exposure:
- 6hr/day on GD 6-18 (GD0 = day of copulation)
- Frequency of treatment:
- 6hrs/day
- Duration of test:
- to GD 29
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 25, 50, 100 or 200 ppm (0, 121, 242, 483 or 966 mg/m3)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 24-26, 49-51, 96-100, 195-207ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 24 per dose group.
- Control animals:
- yes, sham-exposed
- Details on study design:
- no further information
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes daily
BODY WEIGHT: Yes, days GD 0, 9, 12, 15, 18, 21, 29
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29 (eleven days after the last exposure).
- Organs examined: liver, kidney, thymus, spleen, uterus.
- haematologic analysis also carried out for erythrocyte count, haemoglobin and hematocrit. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- other: dead and live fetuses. Non-gravid animals also examined for signs of resorptions. - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: Yes - Statistics:
- For continuous variables: comparison with control by Levene's test for equal variances, ANOVA and t test with Bonferroni probabilities. Non-parametric data compared using Kruskal-Wallis test followed by Mann-Whitney U test when appropriate. Incidence data compared using Fisher's exact test. Significance level of 0.05 used for all assessments.
- Indices:
- no data
- Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Clinical observations included periocular wetness, perinasal wetness and discharge, red fluid on trays under age and stained fur. At 200 ppm four females died or were sacrificed by the third day after the onset of dosing and four aborted. All were pregnant. There was no effect on pregnancy rate across treatment groups. Maternal body weight loss was observed in all groups including controls during exposure, but the difference was greatest at 200 ppm and, by GD15, the actual body weight at 200 ppm was significantly lower. Exposure to 200 ppm produced a significant reduction in maternal body weight (8%), gravid uterine weight (22%) and number of total implants and viable implants.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 ppm
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 100 ppm
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
There was a signficant reduction in the number of total and viable implants at 200ppm, but no effects on number of non-viable implants, pre-implantation loss, percent live fetuses, sex ration or male and female body weight per litter. There was no statistically significant increase in the number of fetuses or litters with one or more affected fetuses with pooled external, visceral, skeletal or total malformations in any treatment group relative to controls. For individual malformations, there was a significant increase relative to controls in the number of litters at 100 ppm with one or more foetuses exhibiting fusion of papillary muscles in the left ventricle. Five foetuses from 4/19 litters were affected. However, since this malformation was not observed at the higher or other concentrations it was considered by the authors, the reviewers and the rapporteur as coincidental and not treatment-related. The incidences of skeletal variations did not indicate an adverse treatment effect on ossification. There were significant decreases in the incidences of litters at 200 ppm with unossified sternebra 6 and with rudimentary ribs on lumbar vertebra 1. However the former observation was indicative of better ossification and the latter observation was because more ribs at 200 ppm were full (extra) rather than rudimentary and there were actually no intergroup differences in supernumerary rib numbers. No other variations were observed. Rudimentary rib or extra rib was seen across all groups at relatively high frequency with no apparent exposure related incidence.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
No adverse reproductive effects were observed in animals exposed to 25 ppm or 50 ppm. At 200 ppm four females died or were sacrificed by the third day after the onset of dosing and four aborted. The blood samples taken at necropsy on GD29 (eleven days after the last exposure) showed increased haemoglobin concentration and haematocrit at 100 and 200 ppm, but statistical significance was only evident at 100 ppm. There were no significant increases in the number of foetuses or litters with one or more affected foetuses with pooled external, visceral, skeletal (total) malformations in any treatment group.
Applicant's summary and conclusion
- Conclusions:
- Exposure of rabbits to 2-butoxyethanol by vapour during pregnancy results in both maternal toxicity and developmental toxicity at concentrations of 200ppm.
- Executive summary:
In a GLP developmental toxicity study, pregnant rabbits were exposed to 2 -butoxyethanol vapour at concentrations up to 200ppm during GD6 -18. The results indicated that exposures of up to 100ppm were without effect but exposures of 200ppm produced both maternal toxicity, manifest as reduced body weight and gravid uterine weight, and toxicity to the conceptus (embryotoxicity), manifest as as fewer viable implants. There was no evidence of teratogenicity. This result can be extrapolated to the acetate ester of this substance.
Synopsis
NOAEC (maternal) =100ppm
NOAEC (developmental) =100ppm
Similar values would apply for butoxyethyl acetate.
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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