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EC number: 906-265-7 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
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- Endpoint summary
- Stability
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Principles of method if other than guideline:
- Assessing the effect of EG on fertility and general reproductive performance in male and female rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ethane-1,2-diol
- EC Number:
- 203-473-3
- EC Name:
- Ethane-1,2-diol
- Cas Number:
- 107-21-1
- Molecular formula:
- C2H6O2
- IUPAC Name:
- 1,2-ethanediol
- Reference substance name:
- ethan-1,2,-diol
- IUPAC Name:
- ethan-1,2,-diol
- Details on test material:
- purity: 99.93%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult nulliparous Fischer 344 rats were housed two per cage in stainless-steel wire cages at 20-24°C with controlled lighting (12 hr light) and fed Purina Formulab and city water ad libitum. During mating, each male was housed with 2 females. After mating and during lactation, the female rats were housed individiually in plastic showbox cages with hardwood chips for nesting. At study initiation the animals were randomly assigned to receive dietary EG at approximate dosages of 1.0, 0.2, or 0.04 g/kg/day.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- 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. However, the concentration of EG 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 as based on earlier unpublished results from the laboratory. Increased food consumption during lactation has since been reported in another study performed at the laboratory.
- Details on mating procedure:
- At approximately 100 days of age, 10 males were added to 20 females in each dosage group. The date of parturition and 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 individualiy at 21 days postpartum, the day they were weaned.
F1 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 F1 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. - Duration of treatment / exposure:
- 3 generations
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/kg diet
- Dose / conc.:
- 200 mg/kg diet
- Dose / conc.:
- 1 000 mg/kg diet
- No. of animals per sex per dose:
- 30
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Reproductive function was tested in a protocol that allowed continuous breeding during a 14-week period. Small, but statistically significant, decreases were found in the numbers of litters per fertile pair and in live pups per litter in the 1.0% dose group and in live pup weight at the 0.5 and 1.0% concentrations. Facial anomalies were noted in the offspring of mice at the high concentration of EG. Skeletal examination revealed a pattern of reduction in the size of bones in the skull, fused ribs, and abnormally shaped sternebrae and vertebrae in the highest dose group.
- Positive control:
- yes
Examinations
- Postmortem examinations (parental animals):
- Necropsies were performed on five males and five females randomly selected from each dosage level of the F2 parents and the F3 weanlings. Microscopic examulations 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 wes 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 metbod 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 litters 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 21day 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:
- yes
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
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No treatment-related effect was observed for any of the reproductive indices.
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- There were no reproductive effects associated with the inclusion of as much as 1.0 g/kg/day of EG in the diet.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histopathologic findings: There were no treatment-related histopathologic findings in F2 parents. Although the kidney has been shown to be the primary target organ for EG-induced toxicity, there was no increase in the incidence or severity of kidney lesions in this study. One high dose F2 animal of each sex had mild focal interstitial nephritis. However, this condition was also seen in a control male and a control female. Unilateral hydronephrosis occurred in another high-dose F2 male.
Results: F1 generation
General toxicity (F1)
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- EG treatment did not affect neonatal body weight at days 4, 14, or 21 post partum.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
General toxicity (F2)
- Description (incidence and severity):
- There were no treatment-related histopathologic findings in F3 weanlings. Although the kidney has been shown to be the primary target organ for EG-induced toxicity, there was no increase in the incidence or severity of kidney lesions in this study. One high dose F2 animal of each sex had mild focal interstitial nephritis. However, this condition was also seen in a control male and a control female. IMild focal tubular hyperplasia was observed in one high-dose male F3 pup but was also diagnosed in two control male pups.
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (F2)
- Critical effects observed:
- no
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Reproductive Indices
1.0 g/kg/d | 0.2 g/kg/d | 0.04 g/kg/d | 0.0A | 0.0B | ||
F0 -> F1 | Fertility index (%) | 100 | 90 | 100 | 90 | 90 |
Male | 95 | 90 | 90 | 75 | 90 | |
Female | 100 | 100 | 100 | 100 | 100 | |
F1 -> F2 | Fertility index (%) | 100 | 100 | 90 | 90 | 90 |
Male | 85 | 95 | 85 | 90 | 85 | |
Female | 100 | 100 | 100 | 100 | 94 | |
F2 -> F3 | Fertility index (%) | 100 | 90 | 100 | 80 | 80 |
Male | 90 | 75 | 85 | 80 | 70 | |
Female | 100 | 100 | 100 | 100 | 100 |
Neonatal body weight at day 21
1.0 g/kg/d | 0.2 g/kg/d | 0.04 g/kg/d | 0.0A | 0.0B | ||
F1 pups | males | 30.6 +/- 4.5 | 30.9 +/- 4.9 | 30.7 +/- 6.4 | 30.6 +/- 3.6 | 27.9 +/- 4.3 |
females | 29.0 +/- 4.5 | 29.2 +/- 4.5 | 29.5 +/- 4.7 | 27.9 +/- 3.3 | 27.0 +/- 3.5 | |
F2 pups | males | 32.8 +/- 3.5 | 30.9 +/- 5.8 | 29.3 +/- 4.7 | 30.0 +/- 4.0 | 28.8 +/- 4.3 |
females | 30.8 +/- 3.4 | 30.2 +/- 4.9 | 28.8 +/- 3.8 | 28.5 +/- 3.1 | 27.5 +/- 3.4 | |
F3 pups | males | 30.2 +/- 4.0 | 30.9 +/- 4.0 | 30.9 +/- 4.0 | 32.0 +/- 3.9 | 30.2 +/- 4.6 |
females | 28.6 +/- 3.8 | 28.2 +/- 3.4 | 29.7 +/- 4.0 | 30.1 +/- 3.5 | 27.7 +/- 3.9 |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, there were no reproductive effects associated with the inclusion of as much as 1.0 g/kg/day of MEG in the diet.
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