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EC number: 204-557-2 | CAS number: 122-60-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
- Reference Type:
- publication
- Title:
- Morphologic expression of glandular differentiation in the epidermoid nasal carcinomas induced by phenylglycidyl ether inhalation.
- Author:
- Lee KP, Schneider PW, Trochimowicz HJ
- Year:
- 1 983
- Bibliographic source:
- Am J Pathol 111(2): 140-8
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 979
- Reference Type:
- publication
- Title:
- Unnamed
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- only 2 concentrations tested, animals were not treated during holidays
- GLP compliance:
- yes
- Remarks:
- no certificate
Test material
- Reference substance name:
- 2,3-epoxypropyl phenyl ether
- EC Number:
- 204-557-2
- EC Name:
- 2,3-epoxypropyl phenyl ether
- Cas Number:
- 122-60-1
- Molecular formula:
- C9H10O2
- IUPAC Name:
- 2-(phenoxymethyl)oxirane
- Details on test material:
- - Name of test material (as cited in study report): Oxirane, (phenoxymethyl)-
- Physical state: colorless liquid
- Analytical purity: 99%
No further information.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Chr:CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 4 weeks
- Weight at study initiation: 131 g (males), no data were given for female rats
- Housing: 3 animals/stainless steel, wire-mesh cages
- Diet (ad libitum): Purina Laboratory Chow Checker #5001
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 4.6 m3 stainless steel and glass chambers, quadrangular in shape with pyramidal tops and bottoms were used for the first 23 months, then 3.5 m3 chambers similarly constructed; all chambers were operated in one-pass, flow-through mode with an air flow rate of approximately 1200 l/min.
- Method of holding animals in test chamber: whole body exposure
- Source and rate of air: approximately 1200 l/min
- Method of conditioning air: Chamber atmospheres were generated by heating liquid PGE in glass washing bottles mounted in silicone oil baths maintained at approximately 125%. Nitrogen gas was metered through the heated sample and the PGE-laden vapours delivered through heated Teflon tubing to the chamber air flow.
- Treatment of exhaust air: exhaust air from chambers were passed through a 1.0 normal NaOH solution for removal of the test substance
TEST ATMOSPHERE
- Brief description of analytical method used: Approximately 10 liter samples of chamber atmospheres were drawn through impingers which contained 0.1 normal NaOH in a 50:50 ethanol:water mixture. The trapped PGE was compared against standards, prepared by adding PGE to the-NaOH solution, with a Bausch and Lomb Nodel 710 spectrophotometer at 270 nm. Chamber atmospheres were measured at approximately 60-minute intervals during each 6-hour exposure with daily time-weighted average concentrations calculated from these data. - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week, excluding holidays
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 1, 12 ppm
Basis:
nominal conc.
corresponding to ca. 0.006 and 0.07 mg/l (calculated by Derelanko M, 2008)
- Remarks:
- Doses / Concentrations:
1.04 +/- 0.11, 11.8 +/- 0.78 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 100
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: The exposure concentrations for this study were based on results of an acute study (6 male rats exposed to 29 ppm of the test substance for 4 hours/day, 5 days/week for 2 weeks followed by a 2 week recovery period) and a subchronic study (32 male and 32 female rats were exposed to 1, 5 or 12 ppm of the test substance for 6 hours/day, 5 days/week for 90 days followed by a 90-day postexposure recovery period).
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily on working days, once on holidays and weekends
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: during each weighing
BODY WEIGHT: Yes
- Time schedule for examinations: twice monthly for the first 6 month, then once monthly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 12, 18 and 24 month after initiation of the study
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data.
- Parameters checked: The hematological parameters measured at each interval consisted of erythrocyte and leukocyte counts; relative (percent of total leukocytes) numbers of neutrophils, lymphocytes, eosinophils, monocytes, and basophils; hemoglobin and hematocrit. Mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration indices were calculated from the erythrocytic data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 12, 18 and 24 month after initiation of the study
- Animals fasted: No data
- How many animals: No data
- Parameters checked: Clinical chemistry examinations consisted of measures of bilirubin, urea nitrogen, and total protein concentrations, and serum activities of alkaline phosphatase, glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, gamma-glutamyl transpeptidase, and lactate dehydrogenase.
URINALYSIS: Yes
- Time schedule for collection of urine: 12, 18 and 24 month after initiation of the study
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked: A 16-hour urine specimen was collected from each rat designated for clinical evaluation before the taking of blood samples. Urine samples were measured for volume, osmolality, and pH and analyzed for the presence of blood, sugar (glucose), urobilinogen, bilirubin, protein, and acetone. Urine color and appearance were recorded and the sediment from pooled group samples was examined microscopically. - Sacrifice and pathology:
- GROSS PATHOLOGY and HISTOPATHOLOGY: Yes
The brain, heart, lungs, liver, spleen, kidneys, stomach, adrenal glands, pituitary, thymus, and testes were weighed and relative organ weights (organ weight to final body weight ratio expressed as percent body weight) were calculated. These organs were also weighed from all rats sacrificed in extremis although relative organ weights were not calculated. Along with these organs, the trachea, salivary glands, esophagus, duodenum, jejunum, ileum, colon, cecum, pancreas, bladder, thyroid, parathyroids, epididymides, prostate, seminal vesicles, ovaries, uterus, mammary gland, eyes, exorbital lacrimal gland, ears (external auditory canal with Zyinbal's gland), lymph nodes (tracheobronchial, cervical, and mesenteric), skeletal muscle (thigh), femur, femoral bone marrow, skin, spinal cord, sciatic nerve, nasal tissue (three coronal sections from the anterior and two coronal sections from the posterior nasal cavity), adipose tissue, and all gross lesions were examined microscopically from male and female rats in all exposure groups. These tissues were also examined from all rats that were sacrificed in extremis or found dead (tissue integrity permitting). The lungs, trachea, thyroid, parathyroids, pituitary, adrenal glands, testes, and kidneys were fixed in Bouin's solution while all other tissues were fixed in 10% formalin. The tissue sections were stained with hemotoxylin and eosin, alcian blue, or trichrome stains or by the periodic acid-Shiff (PAS) method. - Other examinations:
- The epichlorohydrin content present in the test substance was determined.
As part of the analyses of purity, the American Public Health Association (APHA) color of the test substance was determined. - Statistics:
- Body weights, organ weights (absolute and relative), and clinical laboratory data were analyzed by a one-way analysis of variance. When the test for difference among the test group means (F-test) was significant, pairwise comparisons were made between test and control groups. For body weights, body weight gains, and clinical laboratory data these comparisons were made with the least significant difference (LSD) test. For organ weights, the comparisons were made with both LSD and Dunnett's tests. Bartlett's test for homogeneity of variances and a test for linear trend were conducted on the organ weight data. The incidences of clinical observations and mortality were analyzed by Fisher's Exact test. Survival probabilities were estimated by the Kaplan-Meier procedure and differences in survival among groups were judged by the dose-response test of Tarone. Significance for the comparisons of means was judged at the p < 0.05 level.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- survival of male rats exposed to 12 ppm was significantly lower (6 %) than that of male control-group rats and exhibited an exposure-related decrease
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- survival of male rats exposed to 12 ppm was significantly lower (6 %) than that of male control-group rats and exhibited an exposure-related decrease
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 9% greater body weight gain in male rats exposed to 12 ppm compared to control male rats; since food intake was not monitored, biological significance is unclear
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- total leukocyte counts tended to be slightly higher among 12 ppm exposed male rats than among control male rats throughout the study
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- dose-related nasal tumors were developed in the rats exposed to the test substance at 12 ppm
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- undifferentiated glandular cells of the nose appear to differentiate to neoplastic squamous cells
- Details on results:
- GROSS PATHOLOGY
A significantly greater incidence of nasal tumors, most of which were epidermoid carcinomas, was observed in rats exposed to 12 ppm of the test substance. These tumors, which developed in the anterior nasal cavity and frequently invaded the dorso-lateral bones, protruded outward from the nasal cavity causing extensive osteolysis. While one such tumor was detected in a control male rat, none occurred in rats exposed to 1.0 ppm. In addition, rhinitis and squamous metaplasia or dysplasia of the respiratory epithelium and subepithelial gland and in the anterior or nasal cavity occurred with significantly greater frequency in the 12 ppm rats after 24 months on study (see Table 1).
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 0.07 mg/L air (nominal)
- Based on:
- test mat.
- Remarks:
- corresponding to 12 ppm
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 0.006 mg/L air (nominal)
- Based on:
- test mat.
- Remarks:
- corresponding to 1 ppm
- Sex:
- male/female
- Basis for effect level:
- other: no effects
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Any other information on results incl. tables
Table 1: Incidence of pathologic changes in the air passage and nasal tumors of rats (males and females) exposed to the test substance
|
Exposure level (ppm) |
||
0 |
1 |
12 |
|
Rhinitis |
39/176 (22%) |
40/171 (23.3%) |
136/174 (78.1%) |
Squamous metaplasia, nasal epithelium |
6/176 (3.4%) |
8/171 (4.7%) |
125/174 (72.0%) |
Nasal tumor |
1/176 (0.6%) |
-- |
13/174 (7.5%) |
Tracheitis |
13/176 (7.3%) |
13/171 (7.6%) |
16/174 (9.2%) |
Epithelial desquamation/regeneration, trachea |
-- |
-- |
3/174 (1.7%) |
Bronchitis, bronchopneumonia |
2/176 (1.1%) |
3/171 (1.8%) |
7/174 (4.0%) |
Epichlorohydrin was present in the test substance at levels of 25 ppm (in supply containers) and 2.5 ppm (in material that had been used to generate test atmospheres). However, the concentration of epichlorohydrin in the test atmospheres was considered to be very low. Whether the low levels of epichlorohydrin present in the test atmospheres contributed to the development of the nasal tumors observed in this study is, however, uncertain.
The APHA values obtained for PGE ranged from 5-500 for the study. APHA color values of 0-50 are considered "water white" in color whereas values of 500 or greater are considered to be "dark red". Thus, an increase in the APHA value for a liquid over time could be suggestive of the formation of a decomposition product.
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.
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.
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