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EC number: 212-222-7 | CAS number: 770-35-4
- 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: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The methods followed were comprehensively documented in the report. The report included GLP and Quality Assurance statements, signed by the Study Director and Head of the QA Unit, respectively. Although not specifically referenced in the report, generally the study followed EPA Protocol Guideline 870.3200 "21/28-Day dermal toxicity" and OECD 410: "Repeated Dose Dermal Toxicity: 21/28 day." Specifically, the numbers and type of test animals used and their husbandry conditions followed guidance. Test material characterization was adequate. The amount of test material applied complied with guidance, the length of the treatment period was sufficient for this type of test, and evaluation criteria and statistical methods were typical for this type assay and adequately recorded.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline 870.3200 "21/28-Day dermal toxicity" and OECD 410: "Repeated Dose Dermal Toxicity: 21/28 day."
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- 1-phenoxypropan-2-ol
- EC Number:
- 212-222-7
- EC Name:
- 1-phenoxypropan-2-ol
- Cas Number:
- 770-35-4
- Molecular formula:
- C9H12O2
- IUPAC Name:
- 1-phenoxypropan-2-ol
- Reference substance name:
- 1-phenylpropan-2-ol
- EC Number:
- 211-821-0
- EC Name:
- 1-phenylpropan-2-ol
- Cas Number:
- 698-87-3
- IUPAC Name:
- 1-phenylpropan-2-ol
- Details on test material:
- Identity: Dowanol-PPh (1-phenoxy-2-hydroxypropane or
propylene glycol phenyl ether). CAS # 770-35-4 (also
41593-38-8)
Batch No.: LE08011T01
Purity: 95.55% (4.37% DiPPh, 0.08% Phenol)
Supplied as: Not reported
Vapor Pressure: <1.0 mmHg
Specific Gravity: 1.059
Appearance: Liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at dosing: Approximately 5 months of age
- Source: Hazleton-Dutchland, Inc., Denver, PA
- Acclimation period: At least 14 days
- Average weight at start of study: 3-4 kilograms
- Assignment to groups: Computer generated, random number tables
- Diet: Certified Rabbit Chow #5322 (Ralston Purina Company, St. Louis, MO)
- Access to food: Restricted to 8 ounces per day
- Access to water: Available ad libitum in glass bottles
- Method of Identification: Ear tags
- Housing: Individually in stainless steel cages with wire-mesh bottoms
ENVIRONMENTAL CONDITIONS (for non-exposure periods):
- Temperature: ~20°C (Recording frequency not reported)
- Humidity: ~50%. (Recording frequency not reported)
- Air changes: Not specified
- Photoperiod: 12 hr light/12 hr dark
Administration / exposure
- Route of administration:
- dermal
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Propylene glycol phenyl ether was applied daily to the clipped dorsal skin of rabbits (5/sex/dose) at doses of 0, 100, 300, or 1000 mg/kg body weight/day, 5 days/week, over a period of 4 weeks (total of 19 applications). The control group was treated with approximately 1 ml/kg/day distilled water. Propylene glycol phenyl ether was applied uniformly over a 10 x 15 cm area of the back using a syringe with a blunt needle. The dose was covered with gauze, non-absorbent cotton, then an occlusive bandage, all held in place for 6 hours with a lycra/spandex jacket. After the 6 hour exposure period, the bandage was removed and the area washed clean of Propylene glycol phenyl ether with a water-dampened towel.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- not applicable
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once daily, 5 days/week (19 applications total)
- Duration of test:
- 28 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
100 mg/kg body weight/day
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
300 mg/kg body weight/day
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 rabbits/sex/dose
- Control animals:
- other: yes, distilled water (~1 ml/kg)
- Details on study design:
- Propylene glycol phenyl ether was applied daily to the clipped dorsal skin of rabbits (5/sex/dose) at doses of 0, 100, 300, or 1000 mg/kg body weight/day, 5 days/week, over a period of 4 weeks (total of 19 applications). The control group was treated with approximately 1 ml/kg/day distilled water. Propylene glycol phenyl ether was applied uniformly over a 10 x 15 cm area of the back using a syringe with a blunt needle. The dose was covered with gauze, non-absorbent cotton, then an occlusive bandage, all held in place for 6 hours with a lycra/spandex jacket. After the 6 hour exposure period, the bandage was removed and the area washed clean of Propylene glycol phenyl ether with a water-dampened towel.
Over the course of the study, rabbits were monitored for clinical signs of toxicity, body weight changes, hematological, clinical chemistry, and urinalysis changes, as well as gross and microscopic pathology.
Reproductive organs were weighed and subjected to gross and histopathological evaluation. Testis of the males were weighted but female reproductive organs were not. In control and high dose males, the following reproductive tissues were examined microscopically: testis, epididymides, seminal vesicles, and prostate. In control and high dose females, the following reproductive tissues were examined: mammary glands, ovaries, oviducts, uterus, cervix, and vagina - Statistics:
- Descriptive statistics (mean and standard deviation) were reported for white blood cell differential counts and red blood cell indices. Body weights, absolute and relative organ weights, clinical chemistry data and hematology data were evaluated by Bartlett's test for equality of variances. Based on the outcome of Bartlett's test, exploratory data analyses were performed by a parametric or non-parametric analysis of variance (ANOVA), followed respectively by Dunnett's test or the Wilcoxon Ran-Sum test with a Bonferroni correction for multiple comparisons. Statistical outliers were identified by a sequential test and excluded accordingly
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No toxicity to reproductive organs was evident based on organ weights, gross observation, or microscopic examination
Observed effects
Reproductive Organs: No significant differences in testes weights were evident among Propylene glycol phenyl ether treated males. Female reproductive organs were not weighed. In males, gross examination revealed no unusual lesions of testes, epididymides, seminal vesicles, or prostate. In females, gross examination revealed no abnormalities of mammary glands, ovaries, oviducts, uterus, cervix, or vigina. The testis of control and high dose
males were normal. Epididymides of all of the high dose males were normal but one of the controls had very slight chronic interstitial unilateral inflammation and a second control had slight granulomatous, unilateral inflammation of the musculature. Seminal vesicles of all control and treated males were normal. The prostates of all control and treated males were normal. In females, ovaries, oviducts, uteri, cervix, and vagina all were normal. Mammary glands of two of the control females exhibited galactocels but all Propylene glycol phenyl ether treated females were normal. To summarize, no reproductive toxicity was evident from treatment with Propylene glycol phenyl ether.
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Conclusions:
- Propylene glycol phenyl ether applied dermally to the backs of rabbits for 6 hr/day, 5 days/wk over a 28 day period produced no toxicity at dose levels up to 1000 mg/kg-day. This study established a NOAEL of 1000 mg/kg-day. No toxicity to reproductive organs was evident based on organ weights, gross observation, or microscopic examination.
- Executive summary:
Propylene glycol phenyl ether was applied dermally at levels of 100, 300 and 1000 mg/kg body weight/day to the backs of rabbits (5 rabbits/sex/dose) for 6 hr/day, 5 days/wk over a 28 day period (total of 19 applications). The control group was treated with approximately 1 ml/kg/day distilled water. Propylene glycol phenyl ether was applied uniformly over a 10 x 15 cm area of the back using a syringe with a blunt needle. The dose was covered with gauze, non-absorbent cotton, then an occlusive bandage, all held in place for 6 hours with a lycra/spandex jacket. After the 6 hour exposure period, the bandage was removed and the area washed clean of Propylene glycol phenyl ether with a water-dampened towel.
All rabbits survived treatment with no changes in body weights and no overt signs of systemic toxicity. All subjects showed some dermal irritation at the site of Propylene glycol phenyl ether application, characterized by moderate exfoliation and hyperemia in the high dose group, slight exfoliation and transient hyperemia in the mid-dose group, and very slight exfoliation in the low dose group. No changes were noted in absolute or relative organ weights compared to controls. No consistent changes were noted in clinical laboratory studies other than a slight increase in platelet counts in males, which was statistically significant in high dose group and approached significance in mid-dose males. Females showed no platelet response to Propylene glycol phenyl ether exposure. No histopathological changes were noted upon examination of tissues from the high-dose subjects.
Reproductive Organs: No significant differences in testes weights were evident among Propylene glycol phenyl ether treated males. Female reproductive organs were not weighed. In males, gross examination revealed no unusual lesions of testes, epididymides, seminal vesicles, or prostate. In females, gross examination revealed no abnormalities of mammary glands, ovaries, oviducts, uterus, cervix, or vigina. The testis of control and high dose males were normal. Epididymides of all of the high dose males were normal but one of the controls had very slight chronic interstitial unilateral inflammation and a second control had slight granulomatous, unilateral inflammation of the musculature. Seminal vesicles of all control and treated males were normal. The prostates of all control and treated males were normal. In females, ovaries, oviducts, uteri, cervix, and vagina all were normal. Mammary glands of two of the control females exhibited galactocels but all Propylene glycol phenyl ether treated females were normal. To summarize, no reproductive toxicity was evident from treatment with Propylene glycol phenyl ether.
This study established a NOAEL of 1000 mg/kg-day. No toxicity to reproductive organs was evident based on organ weights, gross observation, or microscopic examination.
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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