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Diss Factsheets
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EC number: 204-420-7 | CAS number: 120-72-9
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer-reviewed journal
- Justification for type of information:
- Data is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- FURTHER STUDIES ON INCOMPLETE CARCINOGENESIS: TRIETHYLENE MELAMINE (T.E.M.), 1,2-BENZANTHRACENE AND ,3-PROPIOLACTONE, AS INITIATORS OF SKIN TUMOUR FORMATION IN THE MOUSE.
- Author:
- F. J. C. ROE AND M. H. SALAMAN.
- Year:
- 1 954
- Bibliographic source:
- Cancer Research Department, London Hospital Medical College, London, E.1. December 18, 1954.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below mentioned
- Principles of method if other than guideline:
- Subchronic repeated dermal toxicity study was conducted to determine the toxicity of test substance in male mice.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl formate
- EC Number:
- 203-721-0
- EC Name:
- Ethyl formate
- Cas Number:
- 109-94-4
- Molecular formula:
- C3H6O2
- IUPAC Name:
- Ethyl formate
- Details on test material:
- - Name of test material (as cited in study report): Ethyl frmate
- Molecular formula (if other than submission substance): C3H6O2
- Molecular weight (if other than submission substance): 74.0784 g/mole
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): No data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Stock albino of the " S " strain
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Details on test animal
- Age at study initiation: 7-9 weeks old.
- Diet :fed on cubes prepared according to the Rowett Institute plus fresh greenstuff twice a week formula
- Water : ad libitum
- Acclimation period:
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: Acetone
- Details on exposure:
- Details on dermal exposure
PREPARATION OF DOSING SOLUTIONS:
All solutions were prepared weight per total volume in the solvent. The preparation of glycine ethyl ester from the hydrochloride is described in the experimental section. The podophyllin extract used was prepared from the crude resin by extraction with acetone. Dosage was calculated on the dry weight of the extract after filtration and evaporation.
positive control: croton oil
TEST SITE
- Area of exposure: whole back, from forelimbs to tail.
The hair was clipped from the whole back, from forelimbs to tail, before treatment and at intervals when necessary. Solutions were delivered from calibrated pipettes, care being taken that they spread as evenly as possible over the whole
clipped area. A glass spreader was used for solutions which did not otherwise spread easily. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 weeks
- Frequency of treatment:
- 10 weekly applications of 0.3ml neat agent
Doses / concentrations
- Dose / conc.:
- 2 760 mg/kg bw/day
- No. of animals per sex per dose:
- No data
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- HISTOPATHOLOGY: Yes
- Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Specimens of skin from mice additional to each group were removed under ether anaesthesia three days after one and/or two applications of the test substance. Mice which died during or were killed at the end of the tests were examined post mortem for lung adenomata and other abnormalities. Specimens for histological examination were fixed in Zenker's fluid, embedded in paraffin wax, and stained with haematoxylin and eosin-Biebrich scarlet.
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 2 760 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other: No Epidermal hyperplasia observed.
Target system / organ toxicity
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 2760 mg/kg bw/day when male “s” strain mice were treated by test substance for 10 weeks dermally.
- Executive summary:
10 weeks repeated dermal study was conducted for test substance on male “s” strain mice with the dose concentration of 2760 mg/kg bw/day (0.3ml in acetone applied) and the histopathologic analysis is done to determine the toxic effects. No significant activity was observed In terms of epidermal hyperplasia. Therefore, NOAEL was considered to be 2760 mg/kg bw/day for test substance when male “s” strain mice were treated for 10 weeks
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