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Diss Factsheets
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EC number: 810-816-6 | CAS number: 1473386-36-5
- 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:
- 8.8 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:
- 264.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. The recommended approach using oral data and assuming the same absorption for inhalation and oral route is used.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 5
- Justification:
- The ECHA default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 12.5 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:
- 1 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. Since dermal absoption was shown to be 0.26 % for analogous substances DNEL is derived assuming 10 % of oral absorption for dermal absorption as a worst case scenario.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 1
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics.
- AF for intraspecies differences:
- 5
- Justification:
- The ECHA default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General
DNEL derivation for the substance is performed under consideration of the recommendations of ECHA REACH Guidance (2010). In view of the data used for evaluation, the "quality of whole database factors" is considered to amount to a value of 1, and is thus not shown in the calculations presented below.
Acute- systemic effects
A short-term DNEL oral is not required as the acute oral and dermal toxicity of the test item is low. The test item was not classified and labelled for acute systemic toxicity, according to Regulation (EC) No 1272/2008 (CLP). Due to the very low vapour pressure of 2-Propenoic acid, heptadecyl ester, inhalation exposure is not considered as relevant.
Acute/short-term and long-term exposure - local effects
Skin irritation/corrosion and sensitization:
The skin irritation and sensitization potential for read across substances 2-Propenoic acid, heptadecyl ester was assessed in several studies.
The substances has been demonstrated to be no skin irritant, but a skin sensitizer. Therefore 2-Propenoic acid, heptadecyl ester is also considered as no skin irritant, but a skin sensitizer.
Eye irritation:
No irritation potential was observed for 2 -Propenoic acid, heptadecyl esters.
Therefore 2-Propenoic acid, heptadecyl ester is also considered as no eye irritant.
However, the monoalkyl or monoaryl or monoalkylaryl esters of acrylic acid are classified as irritating to eyes, respiratory tract and skin with H315, H319 and H335 according to Regulation (EC) No 1272/2008 (CLP).
Thus, a qualitative risk assessment is conducted.
Long-term exposure-systemic effects
Inhalation exposure
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in the 28 -day repeated dose toxicity study are identified as the relevant dose descriptor (NOAEL = 150 mg/kg bw).The oral NOAEL was converted to an inhalation NOAEC, assuming 100 % absorption via the lung and 100 % absorption via the oral route. Inhalation NOAEC = oral NOAEL x 1/sRV(rat) x ABSoral(rat)/ABSinhalation(human) x sRV(human)/wRV(human) With Oral NOAEL: 150 mg/kg bw/day sRV(rat): 0.38 m3/kg bw (8 hours) [standard respiratory volume of the rat] ABSoral(rat)/ABSinhalation(human): 1 [ratio of oral absorption in the rat to inhalative absorption in the human] sRV(human)/wRV(human): 6.7 m3/10 m3 [ratio of human standard respiratory volume to worker respiratory volume]
Accordingly, the oral NOAEL of 150 mg/kg bw/day is converted in an inhalation NOAEC of 264.5 mg/m3.
Taking the above mentioned assessment factors into account, the following worker DNEL is:
Worker DNEL (inhalation exposure) = 264.5 mg/m3 / (1 x 6 x 1 x 5 x 1 x 1) = 264.5 mg/m3 / 30 = 8.8 mg/m3
Dermal exposure
In order to derive the worker DNEL (long-term dermal exposure), the NOAEL assessed in the 28 -day repeated dose toxicity study are identified as the relevant dose descriptor (NOAEL = 150 mg/kg bw). A low dermal absorption was shown for the structural analogous substance dodecyl methacrylate (0.26 %, Jones, O., 2002). As icosyl acrylate has a longer carbon chain, lower water solubility and a higher log Pow it can be assumed that the substance will not penetrate the stratum corneum. However, the NOAEL, taken from the oral repeated dose study, is modified assuming 10 % absorption through the skin as a worst case approach. Considering the appropriate modification and assessment factors, the worker DNEL (long-term dermal exposure) is calculated as follows: - Modification of the dose descriptor:
Dose descriptor of relevant study: 150 mg/kg bw/d (NOAEL) Dermal absorption: 10 % = NOAEL x 10 = 1500 mg/kg bw/d
Taking the above mentioned assessment factors into account, the following worker DNEL is:
Worker DNEL (dermal exposure) = 1500 mg/kg bw/d / (1 x 6 x 4 x 1 x 5 x 1 x 1) = 1500 mg/kg bw/d / 120 = 12.5 mg/kg bw/d
References - ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2. ECHA-2010 -G-19 –EN.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- no hazard identified
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
The test item was not classified and labelled regarding oral, dermal and inhalative toxicity.
Further no consumer use is intended.
Therefore no DNEL`s were derived for the general population risk assessment of 2-Propenoic acid, heptadecyl ester.
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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