Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-989-9 | CAS number: 112-60-7
- 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:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: basic information given
- Justification for type of information:
- Please refer to category document for additional information on read across approach.
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproductive Toxicity of Triethylene Glycol and Its Diacetate and Dimethyl Ether Derivatives in a Continuous Breeding Protocol in Swiss-CD-1 Mice.
- Author:
- Bossert, N.L., Reel, J.R., Lawton, D., George, J.D., Lamb, J.C.
- Year:
- 1 992
- Bibliographic source:
- Fundamental and Applied Toxicology 18, 602-608
Materials and methods
- Principles of method if other than guideline:
- The study was conducted under the NTP Program's RACB protocol, the details of which have been published previously.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-(ethylenedioxy)diethanol
- EC Number:
- 203-953-2
- EC Name:
- 2,2'-(ethylenedioxy)diethanol
- Cas Number:
- 112-27-6
- IUPAC Name:
- 2,2'-[ethane-1,2-diylbis(oxy)]diethanol
- Details on test material:
- purity: approx. 97%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were 6 weeks of age. Two males and two females were killed and their were evaluated for antibodies against mouse viruses. All sera were negative for viral antibodies.
After a 2-week quarantine period, all study animals were individually identified, stratified by body weight, and randomly assigned to treatment groups.
Throughout these studies, all animals were housed in solid-bottom polypropylene or polycarbonate cages with Ab-Sorb-Dri bedding. Male and female mice were group-housed by sex during quarantine and for the I-week premating period. Subsequently, the animals were housed individually or as breeding pairs. Deionized/filtered water and ground rodent chow (NIH-07) were provided ad libitum. Automatically controlled photoperiods were 14 hr light/10 and temperature was maintained at 70 ± 2°F. Cages were sanitized weekly using detergent and 180°F water.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- The treatment solutions for each test compound were independently formulated by mixing the test compound (w/v) directly into different proportions of distilled water. An aliquot of each formulation of each chemical in the drinking water and the control water and bulk chemical were sent to Midwest Research Institute at 6-week intervals for confirmation of dose levels and certification of the stability of the bulk chemical.
- Details on mating procedure:
- Triethylene glycol was administered in drinking water to breeding pairs (20 pairs per treatment group, 40 control pairs) during a 98-day cohabitation period.
- Duration of treatment / exposure:
- beginning 1 week before mating of the F0-generation until end of lactation period of the F2-generation
- Frequency of treatment:
- continuously
- Details on study schedule:
- Reproductive function was assessed by the number oflitters per pair, live pups per litter, proportion of pups born alive, and pup weight.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 0.3; 1.5 and 3% (= 0, 590, 3300 and 6780 mg/kg bw/day)
Basis:
nominal in water
- No. of animals per sex per dose:
- 20 males and 20 females per dose group , 40 control animals per sex in the control group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- This study consists of 4 tasks:
Task 1 - dose-setting study
Task 2 - continuous breeding phase
Task 3 - crossover mating trial used to determine the affected sex when a positive effect on fertility is detected in Task 2
Task 4 - assesses the reproductive performance of the offspring from Task 2 breeding pairs
On the basis of the reduced body weight gain and increased mortality (12.5%) in the 5% test group, exposure levels of 0, 0.3, 1.5 and 3% TEG were selected for this study.
Examinations
- Parental animals: Observations and examinations:
- Body weight, kidney weight, liver weight, mortality, food consumption, water consumption, clinical signs.
- Oestrous cyclicity (parental animals):
- Estrous cycle length
- Sperm parameters (parental animals):
- Spem concentration, motility, and morphology
- Litter observations:
- Pup growth to weaning, mortality
- Postmortem examinations (parental animals):
- Litters/pair, live pups/litter, cumulative days to litter, absolute testes/epididymis weight, sex accessory gland weight, epidid. sperm parameters.
- Statistics:
- Statistical analysis was performed. The level of significance for all tests was set at p<0.05.
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
During Task 2, a total of 6 animals died - 2 females in the control, 1 male and 1 female in the 1.5% test group and 2 females in the 3% test group. The random distribution of deaths across treatment groups suggests that they were not treatment-related.
TEG during Task 2 had no effect on fertility or reproductive performance as indicated by the proportion of pairs able to produce at least 1 litter, number of litters produced per pair, number of live pups per litter or proportion of pups born alive. Continuous exposure to 1.5 or 3% significantly reduced mean live pup weight compared to the corresponding weights in the 0 and and 0.3% test group. Since TEG exerted minimal effects on reproductive performance in the Task 2 parental mice (P generation), the effect of TEG on 2 -generation fertility was assessed. The exposure was continued and the final Task 2 litters (F1), of the control and 3% TEG groups were reared to maturity (74 +/- 10 days) and then these F1 offspring were mated to non-siblings from the same treatment group. Mice from the final Task 2 litters were weighed at births and on day 21 and day 74 +/- 10, and no significant differences were observed.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 6 780 mg/kg bw/day
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results: F1 generation
Details on results (F1)
Necropsy of the F1 male offspring showed that the highest concentration had no effect on body weight, testis, epididymis, seminal vesicle, or prostate weight, epididymal sperm concentration, percentage motile sperm, or percentage morphologically abnormal sperm. Necropsy of the F1 females showed no change in body or liver weight. The weights of the brain, pituitary, ovary, oviduct, and uterus were similarly unaffected. In contrast, TEG significantly increased liver weight in males and when organ weights were adjusted for body weight, 3% TEG significantly increased female liver weight compared to controls.
Furthermore, similar to the P generation, continuous exposure of the F1 mice to 3% TEG affected neither the mating index nor the fertility index.
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 6 780 mg/kg bw/day
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Effect of TEG on fertility and reproductive performance:
0% TEG | 0.3% TEG | 1.5% TEG | 3.0% TEG | |
No. fertile/No. cohabited | 37/37 | 19/20 | 18/18 | 18/18 |
Litters/pair | 4.8 +/- 0.1 (37) | 4.8 +/-0.2 (19) | 4.8 +/- 0.2 (18) | 4.6 +/- 0.3 (18) |
Live pups/litter | 11.7 +/- 0.4 (37) | 12.2 +/- 0.5 (19) | 11.7 +/- 0.6 (18) | 10.9 +/- 0.7 (18) |
Proportions of pups born alive | 0.96 +/- 0.02 (37) | 0.98 +/-0.01 (19) | 0.97 +/- 0.02 (18) | 0.96 +/-0.03 (18) |
Live pup weight (g) | 1.66 +/- 0.02 (37) | 1.63 +/- 0.02 (19) | 1.60 +/- 0.02 (18)* | 1.59 +/- 0.02 (18)* |
* Pairs of mice were cohabited and dosed with the appropoirate chemical for 14 weeks. Pairs were considered fertile if they produced one or more litters.
Effect of TEG on male body and organ weights and sperm parameters at necropsy (The 5th litter produced during Task 2 was allowed to grow until 74 +/- 10 days of age. They received either control or chemical treatment via lactation until weaning and then dosed with drinking water until necropsy at 95 +/- 10 days of age. Each value is the mean +/- SE of 20 mice. ND = parameter not determined.)
Weight or sperm parameter | 0 (control) | 3% |
Body (g) | 33.2 +/- 0.4 | 33.1 +/- 0.9 |
Liver (g) | 2.02 +/- 0.03 | 2.13 +/- 0.05* |
Kidneys/adrenals (g) | ND | ND |
Right testis (mg) | 120 +/- 4 | 115 +/- 4 |
Right epididymis (mg) | 47 +/- 1 | 43 +/- 1 |
Prostate (mg) | 34 +/- 4 | 32 +/- 3 |
Seminal vesicles (mg) | 285 +/- 13 | 305 +/- 17 |
Motile sperm (%) | 52 +/- 7 | 54 +/- 5 |
Abnormal sperm (%) | 5.8 +/- 1.5 | 4.9 +/- 1.4 |
Sperm concentration** | 700 +/- 35 | 719 +/-38 |
* significantly different (p<0.05) from the control group
** No. sperm x 10(3)/mg caudal tissue
Effect of TEG on female body and organ weights at necropsy (The 5th litter produced during Task 2 was allowed to grow until 74 +/- 10 days of age. They received either control or chemical treatment via lactation until weaning and then dosed drinking water until necropsy at 95 +/- 10 days of age. Each value is the mean +/- SE of 20 animals.)
Weight (g) | 0 (control) | 3% |
Body | 30.4 +/- 0.5 | 29.4 +/- 0.6 |
Liver | 2.01 +/- 0.05 | 2.02 +/- 0.07 |
Applicant's summary and conclusion
- Conclusions:
- The test substance was not a reproductive toxicant in either generation of mice when administered in drinking water at concentrations of up to 3%, although developmental toxicity was noted in the first generation as reduced pup body weight.
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.