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EC number: 204-589-7 | CAS number: 122-99-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Jul 1983 - 28 Mar 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Evaluation of a new reproductive toxicology protocol using diethylstilbesterol (DES) as a positive control compound
- Author:
- Reel, J. R. et al.
- Year:
- 1 985
- Bibliographic source:
- Journal of American College of Toxicology 4: 147-162
- Reference Type:
- publication
- Title:
- Assessment of ethylene glycol and monophenyl ether reproductive toxicity using a continunous breeding protocol in Swiss CD-1 mice
- Author:
- Heindel, J. J. et al.
- Year:
- 1 990
- Bibliographic source:
- Fund Appl Toxicol 15: 683-696
- Reference Type:
- publication
- Title:
- Ethylene Glycol Monophenyl Ether
- Author:
- Lamb, J. C. and Reel, J. R.
- Year:
- 1 997
- Bibliographic source:
- Environmental Health Perspectives 105(1): 225-226
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Reproductive Assessment by Continuous Breeding (RACB); protocol devised by the NTP
- Version / remarks:
- The RACB protocol does not possess a defined pre-mating exposure. Especially potential effects on male fertility are less likely to become manifest than in the OECD 416 protocol. This deficiency is in part compensated by the cross-breeding (Task 3) which demonstrated the absence of effects on male fertility after a one-week pre-mating exposure.
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Research Triangle Institute
- Limit test:
- no
Test material
- Reference substance name:
- 2-phenoxyethanol
- EC Number:
- 204-589-7
- EC Name:
- 2-phenoxyethanol
- Cas Number:
- 122-99-6
- Molecular formula:
- C8H10O2
- IUPAC Name:
- 2-phenoxyethan-1-ol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ethylene glycol monophenyl ether (EGPE)
- Physical state:
- Analytical purity: 94-95 % (according to Heindel, J. J. et al., 1990)
- Impurities (identity and concentrations): 6 impurities estimated at a total concentration of 5.5-6.0 % were reported, with none of them exceeding 1.0 %
- Lot/batch No.: C093082 / 01
- Stability under test conditions: Doses were freshly prepared on a weekly basis. Analysis of EGPE in the feed showed a 5.0 % loss in the course of one week.
- Storage condition of test material: stored tightly sealed at 25 °C
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding laboratories Inc., NY
- Age at study initiation: 11 weeks of age at the start of the continuous breeding
- Diet (e.g. ad libitum)
- Water (ad libitum)
- Housing: group housed in solid bottom polypropylene or polycarbonate cages
- Acclimation period: 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): monitored by electronic hygrothermographs
- Air changes (per hr): 12-14 times per hour
- Photoperiod (hrs dark / hrs light): 10 /14
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
Each dose of ethylene glycol monophenyl ether (EGPhE) was independently blended into a small amount of ground feed. This mixture was added to a preweighed portion of feed and mixed in a blender for 15 min. Dosed feed was found to lose about 5% of test material over 7 days, therefore, dosed feed was prepared fresh weekly. Concentrations were found to be within 96-105 % of target levels. - Details on mating procedure:
- Premating exposure period
Male : 7 days
Female : 7 days
Continuous breeding
Deviation from OECD 416: Differing from the defined pre-mating treatment period laid out in OECD 416, the RACB protocol involves a 98-day continuous breeding period. Unlike the OECD protocol, copulation takes place among animals without appreciable pre-treatment. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analysis of aliquots of 6 representative samples over the study period revealed EGPE concentrations in the preparations which were within 96-105 % of the expected values.
- Duration of treatment / exposure:
- 7 days prior to and during a 98-day cohabitation period
- Frequency of treatment:
- Oral feed:
in food, offered ad libitum - Details on study schedule:
- Task 1: 14-day dose setting study (range finder)
Task 2: Both sexes were dosed for 7 days prior to and during a 98-day cohabitation period
Task 3: Pairs (P) are mated for 7 days or until a copulatory plug was detected. Treatment was discontinued for all animals during this week then reinstated at the appropriate dose until necropsy (3 weeks after the 7-day cross-over period).
Task 4: the last litter from task 2 is nursed, weaned, reared to sexual maturity while housed by sex two or three per cage and exposed to the same concentration of the test materials as their parents. At 74 ± 10 days of age, males and females from different litters within the same treatment group are cohabited for 7 days or until copulatory plug was seen and then housed individually until delivery. At the end of Task 4, the F1 mice were sacrificed and necropsied.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.25 other: % (nominal)
- Remarks:
- main study (concentrations selected on the basis of range finder)
- Dose / conc.:
- 1.25 other: % (nominal)
- Remarks:
- main study (concentrations selected on the basis of range finder)
- Dose / conc.:
- 2.5 other: % (nominal)
- Remarks:
- main study (concentrations selected on the basis of range finder)
- Dose / conc.:
- 1 other: % (nominal)
- Remarks:
- range finder
- Dose / conc.:
- 2.5 other: % (nominal)
- Remarks:
- range finder
- Dose / conc.:
- 5 other: % (nominal)
- Remarks:
- range finder
- Dose / conc.:
- 10 other: % (nominal)
- Remarks:
- range finder
- No. of animals per sex per dose:
- Task 1: 8 animals per sex per group
Task 2: 40 breeding pairs for control, 20 breeding pairs per treatment group
Task 3: 3 groups of 20 pairs
Task 4: 19 pairs/group - Control animals:
- yes, plain diet
- Details on study design:
- Animals were 6 weeks old upon receipt and were quarantined for 2-5 weeks. During this period, 2 females and 2 males were killed and their sera was analyzed for 11 viruses. All tests were negative. They were randomly assigned to groups by body weight.
Examinations
- Parental animals: Observations and examinations:
- Food consumption, parental body weights (time not specified), mortality and clinical signs of toxicity of parents were evaluated.
- Oestrous cyclicity (parental animals):
- examined
- Sperm parameters (parental animals):
- testes weight, epididymes weight, enumeration of cauda epididymidis sperm reserve, sperm motility, sperm morphology
- Litter observations:
- number and sex of pups, live births, live pup weight
- Postmortem examinations (parental animals):
- Organ weights:
Uterus, ovaries, testes, epididymes (total and cauda), prostate, seminal vesicles, brain, liver, pituitary
Histopathology:
Vagina
uterus
ovaries
oviduct
testis
epididymes
seminal vesicle
prostate
coagulating gland - Postmortem examinations (offspring):
- Organ weights:
Uterus, ovaries, testes, epididymes (total and cauda), prostate, seminal vesicles, brain, liver, pituitary
Histopathology:
Vagina
uterus
ovaries
oviduct
testis
epididymes
seminal vesicle
prostate
coagulating gland - Statistics:
- The Cochran-Armitage test was used to evaluate any dose-related trends in fertility. A chi square test was used to analyze data from Task 3. Pairwise comparisons between the control and dosed groups were made with the Fisher's exact test. The number of litters and the number of live pups per litter were computed on a fertile pair basis and treatment group means were determined. Dose groups means for these variables, the sex ratio and the proportion of live pups were analyzed using a Kruskal-Wallis test. Ordered differences were tested for by Jonckheere's test.
The Wilcoxon-Mann-Whitney U test was used to make intergroup pairwise comparisons.
An analysis of covariance was performed to correct for the potential effect of the number of pups per litter on the average pup weight. The covariate used was average litter size, including live and dead pups. Least squares estimated of dose group means, adjusted for litter size, were computed and tested for overall equality using an F test and pairwise equality was tested using a t test. Average organ weights adjusted for body weight were tested for equality an analysis of covariance. Absolute organ weights were analyzed by the Kruskal-Wallis and Wilcoxon-Mann-Whitney U tests. Dose-related trends were tested for by Jonckheere's test.
Analyses were performed on data for males and females separately and with both sexes combined. The criterion for significance was p<0.05.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
Task 2: Continuous exposure of CD-1 mice to these dietary levels had no effect on the number of pairs able to produce at least one litter. No effect on the sex (males/total) of pups born alive was observed. In contrast, exposure to 2.5 % in the feed tended to reduce the number of litters delivered perpair and significantly reduced the average litter size and proportion of pups born alive compared to the control and the 0.25 % and 1.25 % groups. Further there was a significant (p < 0.01) dose-related decrease in live pup weight during continuous exposure of F0 breeding pairs as revealed by Jonckheere’s Test. Live pup weight adjusted for total pups per litter showed a similar dose-related pattern.
Task 3: The proportion of detected matings, fertile pairs pups born alive, sex of pups born alive (males/total) or number of pups/litter did not differ significantly across the three combinations of breeding pairs, absolute live pup weight (sexes combined) adjust for total pups / litter was significantly (p>0.01) decreased for the control males x 2.5 % test substance females versus the control females x control males and 2.5 % test substance males x control females. The results implied that 2-phenoxyethanol was selectively fetotoxic in the F0 females. The control and 2.5 % test substance exposed F0 mice were necropsied three weeks after the 7-day crossover mating period. No significant effects were observed in % motile sperm, sperm concentration, or % abnormal sperm in cauda epididymidis between male control mice and males of the 2.5 % test group. Also no significant effects were observed with respect to brain, pituitary, left testis/epididymes, right testis and prostate weights. However, body weight and seminal vesicle weight were significantly reduced (p > 0.05) and liver weight significantly increased (p > 0.01). When adjusted to body weight the differences in seminal vesicle weight was no longer statistically significant different from control. Liver weight was also significantly increased in female mice fed 2.5 % test substance in the diet compared to control. Body, brain, pituitary, ovary/oviduct and uterine weights did not differ significantly when compared to control.
EGPE reduced reproductive performance at doses that increased liver weights in treated F0 mice.
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Remarks:
- general effects
- Effect level:
- ca. 3 700 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- Dose descriptor:
- LOAEL
- Remarks:
- reproductive effects
- Effect level:
- > 3 700 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: based on the absence of effects on male fertility
- Dose descriptor:
- LOAEL
- Remarks:
- general effects
- Effect level:
- ca. 3 700 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- organ weights and organ / body weight ratios
- Dose descriptor:
- LOAEL
- Remarks:
- reproductive effects
- Effect level:
- ca. 1 875 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Remarks:
- general effects
- Effect level:
- ca. 1 875 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: no adverse effects
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive effects
- Effect level:
- ca. 3 700 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: no adverse effects
- Dose descriptor:
- NOAEL
- Remarks:
- general effects
- Effect level:
- ca. 1 875 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: no adverse effects
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive effects
- Effect level:
- ca. 1 875 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: no adverse effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
Details on results (F1)
After the delivery of the F2 pups, the control and the 1.25 % group F1 mice were killed and necropsied. The 1.25 % mice weighed 13 % less than controls, their absolute testes weight was 16 % less, and relative seminal vesicles weight was 14 % less than control. The 1.25 % female test group weighed 7 % less than controls; there were no adjusted weight changes in the treated females. There were no treatment-related alterations in epididymal sperm concentration, motility, or morphology.
The test substance caused reduced body weight in neonates in Task 2, 3, and 4, and reduced post-natal survival in F1 animals that were raised to sexual maturity.
Effect levels (F1)
open allclose all
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- ca. 1 875 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- ca. 1 875 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- ca. 375 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- ca. 375 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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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