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Diss Factsheets
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EC number: 204-260-8 | CAS number: 118-56-9
- 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
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Carcinogenicity
Administrative data
Description of key information
Based on negative genotoxicity data derived for this substance and supportive information from a 2-year carcinogenicity study with methyl salicylate, carcinogenic properties are not expected.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: It is an old study (1963); no GLP. The protocol and results were reported in adequate detail and included hematological studies, gross pathology, and limited histopathological examinations of key organs and tissues
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 2-year feeding study in rats
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: no data
- Age at study initiation: weanling
- Weight at study initiation: ~ 50 g
- Fasting period before study: no data
- Housing: no data
- Diet: ad libitum
- Water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data- Air changes (per hr): no data
- Photoperiod: no data
IN-LIFE DATES: no data - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:DIET PREPARATION
- Rate of preparation of diet (frequency): every other week
- Mixing appropriate amounts with (Type of food): no data
- Storage temperature of food: all diets were stored in sealed cans under refrigeration
- Other: 10% additional methyl salicylate was added at time of mixing to compensate for evaporation
VEHICLE: none - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- daily
- Post exposure period:
- none
- Remarks:
- Doses / Concentrations:
0, 0.1, 0.5, 1 and 2%
Basis:
nominal in diet
equivalent to 0, 50, 250, 500, and 1000 mg/kg bw/day - No. of animals per sex per dose:
- 25/sex/dose (except for 24 males, 26 females in 2% group)
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: the data reported in the subchronic study in rats by the same authors (methyl salicylate/ dietary administration for 17 weeks in rats).
- Positive control:
- no data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: The rats were weighed weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No
FOOD EFFICIENCY: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 3, 11, 17 and 22 months
- Anaesthetic used for blood collection: No data
- Animals fasted: Yes
- How many animals: 10 rats/dose
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- not reported
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- pituitay lesions
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- pituitary lesions
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- no significant increase in any neoplasm
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Animals of the 1.0% and 2.0% groups developed rough hair coats.
In the high-dose (2.0%) group, half of the animals died by week 8 and all of the animals died by week 49 of the study.
BODY WEIGHT AND WEIGHT GAIN: Animals of the 1.0% and 2.0% groups had statistically significant growth inhibition.
HAEMATOLOGY: no hematological effects were observed
ORGAN WEIGHTS: Average organ weights were similar for all animals. however, relative organ to body weight ratios for the testes of male animals and for the heart and kidneys of the female animals of the 1.0% groups were significantly increased.
GROSS PATHOLOGY
Gross lesions of the pituitary gland were observed in 10 animals of the 0.5% group as compared to four animals in the control group. Incidence in the 1.0% group was similar to controls. Animals of the 2.0% group died before the age at which spontaneous lesions develop.
In the 2% group, 29 of the 50 animals had pneumonia, which appeared to be more acute than regularly observed.
Other gross lesions were seen in similar numbers of rats on all diets.
HISTOPATHOLOGY: NON-NEOPLASTIC
See chronic study.
HISTOPATHOLOGY: NEOPLASTIC
Benign pituitary tumors occurred in similar numbers of surviving rats on all diets, with incidence higher in females than males.
Malignant pituitary tumors occurred in 1 male and 2 female rats on the 0.5% diet, but not the 1.0% diet.
Mammary tumors occurred in females rats on all diets. - Relevance of carcinogenic effects / potential:
- Incidence of tumours in rats exposed to methyl salicylate in the diet was not increased over controls. As discussed in the ECHA dissiminated REACH dossier on methyl salicylate, this study and data on other salicylates suggest that salicylic acid and its esters have no carcinogenic potential.
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: for methyl salicylate
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 860 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: Read-across value for homosalate.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Methyl salicylate is not carcinogenic in this test system.
- Executive summary:
Webb and Hansen (1963) administered methyl salicylate in the diet to groups of 24-25 male and 25-26 female Osborne-Mendel rats at dietary concentrations of 0, 0.1%, 0.5%, 1.0% or 2.0%, providing doses of approximately 0, 50, 250, 500, and 1000 mg/kg body weight/day for two years. All rats in the 1000 mg/kg group died by the 49th week. Body weight of both sexes were significantly decreased in both the 500 and 1000 mg/kg group body weight/day groups.
Gross pituitary gland lesions were found in 10 rats at 250 mg/kg bw/day compared to 4 rats in the control groups. Incidence in the 500 mg/kg/day group was similar to controls, while all animals of the 1000 mg/kg/day group died before the usual age at which many spontaneous lesions develop.
Similar kinds and numbers of tumors occurred in rats of all diets except the 1000 mg/kg/day group (premature decedents), with mammary tumors of the females being the most common. Benign pituitary tumors occurred in similar numbers of surviving rats on all diets, with occurrence predominantly in females. Malignant pituitary tumors occurred in one male and two females receiving 250 mg/kg/day. Since no such tumors were reported in either the lower or higher dose groups (50 and 500 mg/kg/day), this low incidence does not clearly indicate any relation with methyl salicylate treatment.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- rat
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on negative genotoxicity data derived for this substance and supportive information from a 2-year carcinogenicity study with methyl salicylate as read-across substance, carcinogenic properties are not expected and thus the substance is not classified for carcinogenicity according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC).
Additional information
No study on carcinogenicity is available for homosalate but a supportive study with the read-across substance methyl salicylate was negative for carcinogenicity. Based on negative genotoxicity data derived for homosalate and supportive information from a 2-year carcinogenicity study with methyl salicylate, carcinogenic properties are not expected and no further studies are proposed.
Justification for selection of carcinogenicity via oral route endpoint:
No study on carcinogenicity is available for homosalate but a supportive study with the read-across substance methyl salicylate was negative for carcinogenicity.
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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