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EC number: 230-991-7 | CAS number: 7397-62-8
- 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:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- it was conducted between August 1976 and the end of 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- To fulfill information requirements on reproductive and prenatal toxicity for butyl glycolate by using data from substance produced in the metabolic pathway e.g., glycolic acid and substances with similar main metabolites in the metabolic pathway(NTP 2004, see assessment in Section 13.2) .
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Three-Generation Reproduction and Dominant Lethal Mutagenesis Studies of Ethylene Glycol in the Rat1
- Author:
- L. DEPASS, M. D. WOODSIDE, R. R. MARONPOT, and C. S. WEIL
- Year:
- 1 986
- Bibliographic source:
- FUNDAMENTAL AND APPLIED TOXICOLOGY 7, 566-572 (1986
- Reference Type:
- publication
- Title:
- NTP-CERHR Expert Panel report on the reproduction and developmental toxicity of ethylene glycol
- Author:
- Center for the evaluation of Rixks to Human Reproduction
- Year:
- 2 004
- Bibliographic source:
- Reproductive Toxicology 18(2004) 457-532
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Animals were randomly assigned to receive 1.0, 0.2, or 0.04 g og EG/kg/day
Two diet control groups, designated 0.0A and 0.0B
Administration of EG to the F0 rats of both sexes began at approximately 7 weeks of age.
At approximately 100 days of age, 10 males were mated to 20 females in each dosage group. On the day of parturition, the number of live and dead newborn were recorded for each litter. The appearance and behavior of dams and pups were observed daily. Litter size was randomly reduced to 10, if necessary, on Day 4 postpartum. Offspring were weighed as litters at 4 and 14 days and individually at 21 days postpartum, the day they were weaned.
Fl rats were randomly selected within each dosage group for the next mating. Each litter was represented except for those conceived very late in the mating period.
The Fl and F2 rats were treated as described for the F0 animals until approximately 100 days of age, at which time the animals were cohabited. Brother and sister matings were avoided for each generation. - GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- When this studye was conducted, authors were not aware of another reproductive study in vivo in rats with EG available. The objective of the study was to evaluate the effect of EG on fertility and reproductive parameteres in male and female rats.
Test material
- Reference substance name:
- Butyl glycollate
- EC Number:
- 230-991-7
- EC Name:
- Butyl glycollate
- Cas Number:
- 7397-62-8
- Molecular formula:
- C6H12O3
- IUPAC Name:
- butyl glycolate
- Reference substance name:
- Polysolvan O
- IUPAC Name:
- Polysolvan O
- Details on test material:
- name of substance: butyl glycollate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Polyester grade EG was received from Union Carbide Corporation, Hahnville, Louisiana, on January 22, 1975. The sample was 99.93% monoethylene glycol by analysis.
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Remarks:
- Charles River Breeding Laboratories
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - young adult nulliparous Fischer 344 rats
- housed two per cage in stainless-steel wire cages at 20-24°C
- controlled lighting (12 hr light) and
- fed Purina Formulab 5008 Chow (Ralston Purina Co., St. Louis, Mo.)
- city water ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- 1.0, 0.2, or 0.04 g of EG /kg/day
Fresh diet was prepared every 2 weeks with the percentage of EG adjusted, based on the group mean body weight and food consumption, so as to maintain a relatively constant dosage level.
EG concentration in the diet was not changed during gestation or during the first week of lactation, but was reduced two- and threefold during the second and third weeks of lactation, respectively, to adjust for increased food consumption by the dams. This change in concentration was based on earlier data.
EG administration to the F0 rats of both sexes began at approximately 7 weeks of age. At approximately 100 days of age, 10 males were mated to 20 females in
each dosage group.
Fl and F2 rats were treated as described for the F0 animals until approximately 100 days of age. - Details on mating procedure:
- F0 rats of both sexes began at approximately 7 weeks of age. At approximately 100 days of age, 10 males were mated to 20 females in each dosage group.
Fl rats were randomly selected within each dosage group for the next mating.
The Fl and F2 rats were treated as described for the F0 animals until approximately 100 days of age.
Brother and sister matings were avoided for each generation. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- The weekly calculated dosages ranged from 1.0 to 1.3,0.2 to 0.3, and 0.04 to 0.05 g/kg/day for males and from 0.9 to 1.2, 0.2 to 0.3, and 0.04 to 0.06 g/kg/day for females.
- Duration of treatment / exposure:
- For all dosages:
F0: administrtaion of EG started at approximately 7 weeks of age. At approximately 100 days of age, 10 males were mated to 20 females in each dosage group.
F1 & F2: The Fl and F2 rats were treated as described for the F0 animals until approximately 100 days of age. - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 40 mg/kg bw/day
- No. of animals per sex per dose:
- F0: 10 males were mated to 20 females in each dosage group
F1 & F2: as described for the F0 - Control animals:
- yes
- Details on study design:
- see above in Principles of the method
- Positive control:
- no
Examinations
- Parental animals: Observations and examinations:
- Body weights and diet consumption were recorded weekly except during gestation and lactation.
Date of parturition and the number of live and dead newborn were recorded for each litter.
Appearance and behavior of dams and pups were observed daily. - Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- Litter size was randomly reduced to 10, if necessary, on Day 4 postpartum.
- Postmortem examinations (parental animals):
- Necropsies were performed on five males and five females randomly selected from each dosage level of the F2 parents.
Microscopic examinations were performed on sections of liver, kidneys, lung, heart, adrenals, thyroid, trachea, accessory sex glands, adipose tissue, lymph nodes, pituitary, thymus, and testes and epididymis, or uterus and ovaries. - Postmortem examinations (offspring):
- Necropsies were performed on five males and five females randomly selected from each dosage level of F3 weanlings.
Microscopic examinations were performed on sections of liver, kidneys, lung, heart, adrenals, thyroid, trachea, accessory sex glands, adipose tissue, lymph nodes, pituitary, thymus, and testes and epididymis, or uterus and ovaries. - Statistics:
- Continuous data such as body weights were compared by analysis of variance validated by Bartlett's test for homogeneity of variance. Duncan's multiple range test was used to identify individual mean differences when indicated by a significant F value. Where Bartlett's test indicated heterogeneous variances, t tests for equal or unequal variances were used to delineate differences between groups. Pup weights were compared by the method of Weil (Weil, 1970). Discontinuous
data such as implantations and reproductive indices were compared by a multiple sum of ranks test. Frequency data were compared by the x2 test and by Fisher's
exact test. The following reproductive indices were calculated and evaluated statistically by the previously described nonparametric methods: fertility index (male and female), days from first mating to parturition, gestation index (fraction of pregnancies that resulted in Utters with live pups), gestation survival index (fraction of newborn pups alive at birth), 0 to 4-day survival index, 4 to 14-day survival index, 4 to 21-day survival index. The last four indices are summarized in the tables as means for ease of understanding and presentation, although the nonparametric statistical methods did not include a comparison of means. - Reproductive indices:
- The reproductive indices for all three generations are presented in Table 1. No treatment treatment-related effect was observed for any of the indices. Also, EG treatment did not affect neonatal body weight at Days 4, 14, or 21 postpartum.
- Offspring viability indices:
- There were no significant differences among the treatment groups at any time when compare to the controls.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- 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 specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- 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)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects were observed
Results: P1 (second parental generation)
General toxicity (P1)
- 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:
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P1)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects were observed
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- 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 specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- no effects observed
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Mortality / viability:
- 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 specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- not specified
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- no effects observed
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects
- Dose descriptor:
- NOAEL
- Generation:
- other: F3
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No reproductive effects associated with the inclusion of as much as 1000 mg/kg/day of ethylene glycol in the diet were found. The NOAEL for parental animals and for offsprings was found to be > 1000 mg/kg/day.
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