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Diss Factsheets
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EC number: 205-516-1 | CAS number: 141-97-9
- 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:
- 29.167 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 875 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Oral absorption is estimated to be approximately 50%; inhalation absorption of 100% is assumed
- AF for dose response relationship:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance. The use of a larger AF is not warranted on the basis of the data available
- AF for differences in duration of exposure:
- 6
- Justification:
- Starting point was extrapolated from a subacute to a chronic exposure period
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default AF of 4 is used, according to ECHA REACH Guidance
- AF for other interspecies differences:
- 1
- Justification:
- AF 1 used, no indication for differences in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 5
- Justification:
- A default AF of 5 is used, according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- AF of 1 is appropriate: the database is comprehensive and of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance
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:
- 8.333 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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Data indicate a similar extent of absorption following oral and dermal exposure; correction for differences in the extent of absorption is not required.
- AF for dose response relationship:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance. The use of a larger AF is not warranted on the basis of the data available.
- AF for differences in duration of exposure:
- 6
- Justification:
- Starting point was extrapolated from a subacute to a chronic exposure period
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default AF of 4 is used, according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 1
- Justification:
- AF 1 used, no indication for differences in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 5
- Justification:
- A default AF of 5 is used, according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- AF of 1 is appropriate: the database is comprehensive and of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance.
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
Toxicology summary
Toxicokinetics
EAA is a small, relatively mobile mobile, relatively volatile and uncharged molecule with good solubility in hydrophilic and hydrophobic solvents. It is rapidly and to a high degree absorbed after oral exposure, but also causes local toxicity to the intestines. Absorption via the dermis is comparatively lower which may also be due to the volatile behavior. EAA is rapidly excreted after hydrolysis of the ester function and also rapidly eliminated during metabolism. Tests with repeated dose administration demonstrate that cumulation in the body can be excluded.
Acute toxicity
Acute oral toxicity
The acute oral toxicity on rats was determined to be 10'800 mg/kg.
Acute dermal toxicity
The acute dermal toxicity on rats was found to be > 2000 mg/kg.
Acute inhalation toxicity
Study not performed; dermal route was chosen instead.
Irritation/Corrosion
MAA was found to be non-irritating to skin and eyes.
Sensitisation
MAA is not a skin sensitiser.
Repeated dose toxicity
The appropriate doese levels were evaluated in a range-finding test. Based on this RF-study, dose levels of 0, 50, 225 and 1000 mg/kg b.w./day were fixed for the main study, including 2-weeks recovery for low and high dose groups. There were neither premature deaths nor clinical signs as a result of treatment with EAA. No mortality and no clinical symptoms were noted. Furthermore, there were no treatment-related effects observed on body weights, hematology, clinical chemistry, urinalysis, and organ weights. There were also no necropsy and histological findings. In conclusion, in the absence of any effect, the NOEL and NOAEL were determined to be 1000 mg/kg/day.
Genetic toxicity
The test item EAA was tested for genetic toxicity in three in-vitro studies, all with and without metabolic activation. A reverse mutation assay (Ames test), a chromosomal aberration test and an HPRT-test (gene mutation) were performed, according to the corresponding OECD-guidelines. The Ames test used Salmonella typhimurium and E.coli strains and showed a negative result (non-mutagenic). The chromosomal aberration test performed with Chinese V79 cells did not induce clastogenic effects. The HPRT-test used V79 cells and showed neither genotoxicity nor cytotoxicity, therefore EAA was considered to be non mutagenic in this test system
Toxicity to reproduction
The study was performed according to OECD-guideline no. 421. The administration route was oral gavage. Ten animals were treated per sex and dose groups resulting in a total of 80 animals. Dose levels were 0, 50, 225 and 1000 mg/kg/day. There were no effects on clinical signs, mortality, body weights, food consumption. There were minor effects in the highest dose groups on reproduction. However, these findings were considered to be not relevant and therefore, a NOEL of 1000 mg/kg/day was established.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 375 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Oral absorption is estimated to be approximately 50%; inhalation absorption of 100% is assumed
- AF for dose response relationship:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance. The use of a larger AF is not warranted on the basis of the data available
- AF for differences in duration of exposure:
- 6
- Justification:
- Starting point was extrapolated from a subacute to a chronic exposure period
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default AF of 4 is used, according to ECHA REACH Guidance
- AF for other interspecies differences:
- 1
- Justification:
- AF 1 used, no indication for differences in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- A default AF of 10 is used, according to ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- AF of 1 is appropriate: the database is comprehensive and of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance
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:
- 4.167 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):
- 240
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Data indicate a similar extent of absorption following oral and dermal exposure; correction for differences in the extent of absorption is not required.
- AF for dose response relationship:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance. The use of a larger AF is not warranted on the basis of the data available.
- AF for differences in duration of exposure:
- 6
- Justification:
- Starting point was extrapolated from a subacute to a chronic exposure period
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default AF of 4 is used, according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 1
- Justification:
- AF 1 used, no indication for differences in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- A default AF of 10 is used, according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- AF of 1 is appropriate: the database is comprehensive and of good quality.
- AF for remaining uncertainties:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance.
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:
- 4.167 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):
- 240
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Data indicate a similar extent of absorption following oral and dermal exposure; correction for differences in the extent of absorption is not required.
- AF for dose response relationship:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance. The use of a larger AF is not warranted on the basis of the data available.
- AF for differences in duration of exposure:
- 6
- Justification:
- Starting point was extrapolated from a subacute to a chronic exposure period
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- A default AF of 4 is used, according to ECHA REACH Guidance.
- AF for other interspecies differences:
- 1
- Justification:
- AF 1 used, no indication for differences in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- A default AF of 10 is used, according to ECHA REACH Guidance.
- AF for the quality of the whole database:
- 1
- Justification:
- AF of 1 is appropriate: the database is comprehensive and of good quality
- AF for remaining uncertainties:
- 1
- Justification:
- A default AF of 1 is used, according to ECHA REACH Guidance.
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
Toxicology summary
Toxicokinetics
EAA is a small, relatively mobile mobile, relatively volatile and uncharged molecule with good solubility in hydrophilic and hydrophobic solvents. It is rapidly and to a high degree absorbed after oral exposure, but also causes local toxicity to the intestines. Absorption via the dermis is comparatively lower which may also be due to the volatile behavior. EAA is rapidly excreted after hydrolysis of the ester function and also rapidly eliminated during metabolism. Tests with repeated dose administration demonstrate that cumulation in the body can be excluded.
Acute toxicity
Acute oral toxicity
The acute oral toxicity on rats was determined to be 10'800 mg/kg.
Acute dermal toxicity
The acute dermal toxicity on rats was found to be > 2000 mg/kg.
Acute inhalation toxicity
Study not performed; dermal route was chosen instead.
Irritation/Corrosion
MAA was found to be non-irritating to skin and eyes.
Sensitisation
MAA is not a skin sensitiser.
Repeated dose toxicity
The appropriate doese levels were evaluated in a range-finding test. Based on this RF-study, dose levels of 0, 50, 225 and 1000 mg/kg b.w./day were fixed for the main study, including 2-weeks recovery for low and high dose groups. There were neither premature deaths nor clinical signs as a result of treatment with EAA. No mortality and no clinical symptoms were noted. Furthermore, there were no treatment-related effects observed on body weights, hematology, clinical chemistry, urinalysis, and organ weights. There were also no necropsy and histological findings. In conclusion, in the absence of any effect, the NOEL and NOAEL were determined to be 1000 mg/kg/day.
Genetic toxicity
The test item EAA was tested for genetic toxicity in three in-vitro studies, all with and without metabolic activation. A reverse mutation assay (Ames test), a chromosomal aberration test and an HPRT-test (gene mutation) were performed, according to the corresponding OECD-guidelines. The Ames test used Salmonella typhimurium and E.coli strains and showed a negative result (non-mutagenic). The chromosomal aberration test performed with Chinese V79 cells did not induce clastogenic effects. The HPRT-test used V79 cells and showed neither genotoxicity nor cytotoxicity, therefore EAA was considered to be non mutagenic in this test system
Toxicity to reproduction
The study was performed according to OECD-guideline no. 421. The administration route was oral gavage. Ten animals were treated per sex and dose groups resulting in a total of 80 animals. Dose levels were 0, 50, 225 and 1000 mg/kg/day. There were no effects on clinical signs, mortality, body weights, food consumption. There were minor effects in the highest dose groups on reproduction. However, these findings were considered to be not relevant and therefore, a NOEL of 1000 mg/kg/day was established.
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