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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.09 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 207
- Explanation for the modification of the dose descriptor starting point:
- The inhalation NOAEC of 700 mg/m3 from the read across of Methyl salicylate is used and adjusted for molecular weight differences for homosalate to be 1207 mg/m³ .
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for airborne concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 860 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- According to the statement of toxicokinetic assessment, the absorption rate from dermal route is assumed to be <10% and the absorption rate of oral route is considered to be 100%. Therefore, the oral NOAEL of 86 mg/kg bw/d derived from the read across substance Methyl salicylate is converted to a NOAEL for the dermal route by multiplying with 100/10.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL derived from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
According to the results of toxicokinetic assessment, the inhalation route is not considered further as exposure scenarios for test article do not indicate inhalative exposure to be the likely route of exposure to workers in production. However, an inhalative DNEL was derived based on the NOAEC (700 mg/m³), derived from a subacute read-across study on methyl salicylate, in which no toxic signs and no macroscopic or microscopic effects were seen following exposure to a saturated atmosphere within 28 days (7 hours exposure on 5 days/week). This NOAEC was adjusted to 1207 mg/m³ taking into account molecular weight differences from methyl salicylate to homosalate.
The absorption rate from dermal route is assumed to be less than 10% and the absorption rate of oral route is considered to be 100%. Therefore, the oral NOAEL of 50 mg/kg bw/d for general toxicity of methyl salicylate derived in a 2-year carcinogenicity study is converted to an equimolar value of 86 mg/kg bw/d of homosalate and route to route extrapolated to a dermal NOAEL of 860 mg/kg/day by multiplying by a factor of 100/10. As basis for DNEL derivation the result from a chronic study with rats on methyl salicylate was used. In this study, the test item was administered at dosages of 0.1, 0.5, 1 and 2% in diet (equivalent to 50, 250, 500 and 1000 mg/kg bw/d), and controls received diet only. Based on the results of this study, where no test article-related effects were observed at 50 mg/kg bw/d the NOAEL (No Observed Adverse Effect Level) for general toxicity in rats was considered to be 50 mg/kg bw/day (equivalent to 86 mg/kg bw/d homosalate). Hence this study is chosen as basis for dermal DNEL derivation, applying the NOAEL value (86 mg/kg bw/d adjusted to homosalate) in this study. Based on the above description, the basis for the DNEL therefore is this oral NOAEL (86 mg/kg bw/day), and NOAELcorr for the dermal route is 860 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.04 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 207 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The inhalation NOAEC of 700 mg/m3 from the read across of methyl salicylate is used and adjusted for molecular weight differences for homosalate to be 1207 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for airborne concentrations
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 860 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- According to the statement of toxicokinetic assessment, the absorption rate from dermal route is assumed to be <10% and the absorption rate of oral route is considered to be 100%. Therefore, the oral NOAEL of 86 mg/kg bw/d derived from the read across substance Methyl salicylate is converted to a NOAEL for the dermal route by multiplying with 100/10.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL derived from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.86 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 86 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL derived from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
According to the results of toxicokinetic assessment, the inhalation route is not considered further as exposure scenarios for test article do not indicate inhalative exposure to be the likely route of exposure to workers in production. However, an inhalative DNEL was derived based on the NOAEC (700 mg/m³), derived from a subacute read-across study on methyl salicylate, in which no toxic signs and no macroscopic or microscopic effects were seen following exposure to a saturated atmosphere within 28 days (7 hours exposure on 5 days/week). This NOAEC was adjusted to 1207 mg/m³taking into account molecular weight differences from ethyl salicylate to homosalate.
The absorption rate from dermal route is assumed to be less than 10% and the absorption rate of oral route is considered to be 100%. Therefore, the oral NOAEL of 50 mg/kg bw/d for general toxicity of methyl salicylate derived in a 2-year carcinogenicity study is converted to an equimolar value of 86 mg/kg bw/d of homosalate and route to route extrapolated to a dermal NOAEL of 860 mg/kg/day by multiplying by a factor of 100/10. As basis for DNEL derivation the result from a chronic study with rats on methyl salicylate was used. In this study, the test item was administered at dosages of 0.1, 0.5, 1 and 2% in diet (equivalent to 50, 250, 500 and 1000 mg/kg bw/d), and controls received diet only. Based on the results of this study, where no test article-related effects were observed at 50 mg/kg bw/d the NOAEL (No Observed Adverse Effect Level) for general toxicity in rats was considered to be 50 mg/kg bw/day (equivalent to 86 mg/kg bw/d homosalate). Hence this study is chosen as basis for dermal DNEL derivation, applying the NOAEL value (86 mg/kg bw/d adjusted to homosalate) in this study. Based on the above description, the basis for the DNEL therefore is this oral NOAEL (86 mg/kg bw/day), and NOAELcorr for the dermal route is 860 mg/kg bw/day.
To derive the DNEL for oral route the same study was used but no correction for route to route was applied and the adjusted NOAEL of 86 mg/kg bw/d was used directly for DNEL oral derivation, applying the assessment factors as described.
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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