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Diss Factsheets
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EC number: 904-908-6 | CAS number: -
- 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:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of Methyl Salicylate on Rat Reproduction
- Author:
- T. F. X. COLLINS, W. H. HANSEN, AND H. V. KEELER
- Year:
- 1 969
- Bibliographic source:
- Bureau of Foods and Pesticides, Food and Drug Administration, U.S. Department of Health, Education, and Welfare, Washington, D.C. 20204
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: three-generation reproductive toxicity
- Principles of method if other than guideline:
- Principles included in the following reference: FITZHUGH, 0. G. (1968). Modern Trends in Toxicology, I (E. Boyland and R. Goulding, eds.), pp. 75-85. Butterworth, London.
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl salicylate
- EC Number:
- 204-317-7
- EC Name:
- Methyl salicylate
- Cas Number:
- 119-36-8
- Molecular formula:
- C8H8O3
- IUPAC Name:
- methyl salicylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Methyl salicylate
- Molecular formula (if other than submission substance): C8H8O3
- Molecular weight (if other than submission substance): 152.14 g/mol
- Smiles notation (if other than submission substance):
- Physical state: colourless, oily liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
Constituent 1
- Specific details on test material used for the study:
- Synthetic methyl salicylate* was mixed with Purina Laboratory Chow at concentrations of 0, 500, 1500, 3000, and 5000 ppm and fed ad libitum. The diet was prepared every 14 days in a manner identical to that of Webb and Hansen (1963) and according to the results of Jones et al, (1962).
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 100 days
- Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 75 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 20 males and 20 females in each dose group
- Control animals:
- not specified
Examinations
- Litter observations:
- At the birth of the first litter (F,,) observations were made of the number of stillborn and liveborn young and of grossly visible abnormalities. Litters were similarly observed on day 4 and counts were made of the number and conditions of the living pups. When litters exceeded 10 at day 4, the number of pups was reduced to 10. At weaning the animals were sacrificed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not examined
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 75 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F1 generation
General toxicity (F1)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant decreases in average litter size were found in the second generation in the second mating at 3000 ppm (P K 0.05) and in both matings at 5000 ppm. Although decreases were seen at 1500 ppm, they were not statistically significant because of the large variation in progeny between females within a group. A dose-related decrease in average litter size per female exposed was apparent in both matings of the second generation starting at 1500 ppm. When the results were combined for all generations, mating 1 and mating 2, there was a clearly dose-related decrease starting at 1500 ppm.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 75 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Results: F2 generation
General toxicity (F2)
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant decreases in average litter size were found in the second generation in the second mating at 3000 ppm (P K 0.05) and in both matings at 5000 ppm. Although decreases were seen at 1500 ppm, they were not statistically significant because of the large variation in progeny between females within a group. A dose-related decrease in average litter size per female exposed was apparent in both matings of the second generation starting at 1500 ppm. When the results were combined for all generations, mating 1 and mating 2, there was a clearly dose-related decrease starting at 1500 ppm.
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- ca. 75 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 150 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- yes
Applicant's summary and conclusion
- Conclusions:
- Adverse effects were seen at the 3000 and 5000 ppm dose levels (150 and 250 mg/kg), particularly in second generation matings which showed consistent, statistically significant decreases for average litter size, average number of liveborn, and average numbers of survivors to day 4 and day 21. Although no statistically significant decreases were shown in any generation at the 500 or 1500 ppm dose levels (25 and 75 mg/kg) of methyl salicylate fed alone, there were decreases in the number of progeny born per female exposed to mating. These decreases were not significant because of the large variation in number of progeny between females within a group. The decreases, although not statistically significant, indicate possible adverse biological effects.
- Executive summary:
The flavoring agent methyl salicylate was fed at 0, 500, 1500, 3000, and 5000 ppm to Osborne-Mendelr ats for 3 generations,No significant decrease was seen in
the fertility index at any dose.A t the 3000-a nd 5000-ppm levels significant decreases were seen in average litter size, average number of livebom progeny, average number of survivors to day 4, and average number of survivors to weaning.T he decreasews ereg reatesti n the secondg eneration. The decreases eenin the number of liveborn progeny appeared o be dose-related.
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