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Diss Factsheets
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EC number: 203-442-4 | CAS number: 106-92-3
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 0.954 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):
- 10
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 9.54 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health provides for modification of the dose descriptor in calculating DNEL for repeat dose inhalation toxicity.
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 5
- Justification:
- intraspecies – workers
- Justification:
- None
- AF for intraspecies differences:
- 0.5
- Justification:
- For workers (in case of 8 hour exposure / day) Corrected LOAEL (inhalation) = LOAEL (inhalation rat) / AS * srv / Hrv x test time / default working hours. Where: LOAEL: 19 mg/m3 (from 90-day inhalation toxicity study); Srv = 6.7 mg/m3 Hrv = Human respiration rate = 10 m3 / person x 6/8 hours = 19 * 6.7/10 *6/8= 9.54 mg/m3.
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- it is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 896 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4 480 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAEC: derived from LD50 Inhalation Toxicity with appropriate allometric scaling applied. LD50 Inhalation Toxicity = 2.56 mg/l (4 hours) = 2560 mg/m3. APPENDIX R. 8-8 Acute toxicity of Chapter R.8: Characterisation of dose [concentration]-response for human health states in Figure R. 8-5 Decision tree for setting an acute inhalation toxicity DNEL provides for modification of the dose descriptor in calculating DNEL for acute inhalation toxicity. Given a 4-hour exposure is available, it is considered appropriate to scale this value to provide a 4-hour DNEL; the principle that any brief exposure would be below this DNEL
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for interspecies differences (allometric scaling):
- 5
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- None
- AF for intraspecies differences:
- 1.8
- Justification:
- Allometric scaling factor: 4; BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. = 2560 / 4 * 70/10 = 4480 mg/m
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- it is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.26 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- LOAEC
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for interspecies differences (allometric scaling):
- 1.8
- Justification:
- Allometric scaling factor: 4; BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. = 23.6 / 4 * 70/10 = 41.3 mg/m3
- Justification:
- None
- AF for intraspecies differences:
- 5
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- it is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.19 mg/kg bw/day
- 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):
- 40
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 7.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health Example B. 4 Oral# exposure; inhalatory N(L)OAEC rat provides for modification of the dose descriptor in calculating DNEL for repeat dose dermal toxicity (where # denotes similar situation with dermal exposure) Corrected LOAEL (dermal) = inhalatory LOAEC x srv - rat x ABSinh-rat / ABSderm-human Where srv-rat = 0.2 l/min No values exist for ABS. As as a worst case assume ABS inh-rat rat = 100%/ ABSderm-human 50%])
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health; subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for other interspecies differences:
- 0.4
- Justification:
- Corrected LOAEL (dermal) = inhalatory LOAEC x srv - rat x ABSinh-rat / ABSderm-human Where srv-rat = 0.2 l/min No values exist for ABS. As as a worst case assume ABS inh-rat rat = 100%/ ABSderm-human 50%]) Therefore, corrected LOAEL (dermal) = 19 x 0.2 x (100/50) = 7.6 mg/kg/day
- Justification:
- None
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- it is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 127.5 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 550 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-8 Acute toxicity of Chapter R.8: Characterisation of dose [concentration]-response for human health states that although, peak exposures in theory may also occur for the dermal and oral routes, these are not normally assessed, so the establishment of acute toxicity DNELs for dermal and oral peak exposures appears superfluous. However, on a case-by-case basis an ‘acute’ dermal or oral DNEL can be set for comparison with single exposure events. No detailed guidance is given for setting oral or dermal acute toxicity DNELs, but the principles are the same as those described below for setting inhalation acute toxicity DNELs. In the case of the substance effects where seen at above the limit dose used for classification within the EU. However, as the substance is classified as GHS Acute Class 5 for dermal, it is considered appropriate to assess the substance for DNEL. Part B: Hazard Assessment, Section B 6.2 Human health endpoints states that when a limit test has been conducted, and no adverse effects on health have been observed, then the limit dose can be regarded as the dose descriptor in setting the DNEL. In the absence of other information is considered appropriate in this case to utilise the LD50 Dermal toxicity as the DNEL and apply a suitable scaling factor as follows:
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- None
- AF for intraspecies differences:
- 5
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- it is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Taking account of the data from the carcinogenicity studies into consideration, the biological significance of three neoplasms observed in the respiratory tract in male rats could not be assessed due to the lack of historical control data in this strain. The number of tumors in mice is limited, but the rarity of the neoplasms seen in this species and the presence of preneoplastic lesions at the site of the tumors suggests carcinogenic potential. While there is some uncertainty about the mechanism of tumor induction, it is likely that the genotoxic and irritant properties of this substance may play a role in tumourgenesis.
A NOAEL is proposed for carcinogenicity; however, there is insufficient data listed in the report to allow for calculation of DMEL utilisingdose-descriptors T25 and BMD10. Therefore it is proposed that risk characterisation can proceed using a DNEL based on the assumption of a threshold mechanism. The lowest threshold mechanism provided is that for a 90-day inhalation study with a givenLOAEC of 19 mg/m³ (sub chronic; rat) – this value is lower than the NOAEL value proposed from the carcinogenicity study. This data is utilised for the purposes of hazard assessment, with suitable extrapolations.
The “remaining differences” assessment factor is not applied, as it is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.477 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):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 9.54 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health provides for modification of the dose descriptor in calculating DNEL for repeat dose inhalation toxicity.
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 0.5
- Justification:
- For the general public (in case of 8 hour exposure / day) Corrected LOAEL (inhalation) = LOAEL (inhalation rat) / AS * srv / Hrv x test time / default working hours. This is considered appropriate, as the substance is not available to the general public. Where: LOAEL: 19 mg/m3 (from 90-day inhalation toxicity study); Srv = 6.7 mg/m3 Hrv = Human respiration rate = 10 m3 / person x 6/8 hours = 19 * 6.7/10 *6/8= 9.54 mg/m3.
- Justification:
- None
- AF for intraspecies differences:
- 10
- Justification:
- Intraspecies - general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- it is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 448 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4 480 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-8 Acute toxicity of Chapter R.8: Characterisation of dose [concentration]-response for human health states in Figure R. 8-5 Decision tree for setting an acute inhalation toxicity DNEL provides for modification of the dose descriptor in calculating DNEL for acute inhalation toxicity. Given a 4-hour exposure is available, it is considered appropriate to scale this value to provide a 4-hour DNEL; the principle that any brief exposure would be below this DNEL. The following factors are applied: Allometric scaling factor: 4; BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. = 2560 / 4 * 70/10 = 4480 mg/m3. AF = 10 [10 (intraspecies – general population) x 1 (dose-response) x 1 (quality of data base)].
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- None - addresssed in AF for interspecies differences
- AF for other interspecies differences:
- 1.8
- Justification:
- Allometric scaling factor: 4; BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. = 2560 / 4 * 70/10 = 4480 mg/m
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.13 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- None - addresssed in AF for interspecies differences
- AF for other interspecies differences:
- 1.8
- Justification:
- Allometric scaling factor: 4; BW(human) = 70 kg, Hrv = Human respiration rate = 10 m3 / person. = 23.6 / 4 * 70/10 = 41.3 mg/m3.
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.095 mg/kg bw/day
- 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):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health Example B. 4 Oral# exposure; inhalatory N(L)OAEC rat provides for modification of the dose descriptor in calculating DNEL for repeat dose dermal toxicity (where # denotes similar situation with dermal exposure) Corrected LOAEL (dermal) = inhalatory LOAEC x srv - rat x ABSinh-rat / ABSderm-human Where srv-rat = 0.2 l/min No values exist for ABS. As as a worst case assume ABS inh-rat rat = 100%/ ABSderm-human 50%]) Therefore, corrected LOAEL (dermal) = 19 x 0.2 x (100/50) = 7.6 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for other interspecies differences:
- 1.8
- Justification:
- Corrected LOAEL (dermal) = inhalatory LOAEC x srv - rat x ABSinh-rat / ABSderm-human
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 63.75 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 550 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-8 Acute toxicity of Chapter R.8: Characterisation of dose [concentration]-response for human health states that although, peak exposures in theory may also occur for the dermal and oral routes, these are not normally assessed, so the establishment of acute toxicity DNELs for dermal and oral peak exposures appears superfluous. However, on a case-by-case basis an ‘acute’ dermal or oral DNEL can be set for comparison with single exposure events. No detailed guidance is given for setting oral or dermal acute toxicity DNELs, but the principles are the same as those described below for setting inhalation acute toxicity DNELs. In the case of the substance effects where seen at above the limit dose used for classification within the EU. However, as the substance is classified as GHS Acute Class 5 for dermal, it is considered appropriate to assess the substance for DNEL.
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- None
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.095 mg/kg bw/day
- 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):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-2 Bioavailability, route-to-route extrapolation and allometric scaling of Chapter R.8: Characterisation of dose [concentration]-response for human health Example B. 4 Oral exposure; inhalatory N(L)OAEC rat provides for modification of the dose descriptor in calculating DNEL for repeat dose oral toxicity. Corrected LOAEL (oral) = inhalatory LOAEC x srv - rat x ABSinh-rat / ABSoral-human Where srv-rat = 0.2 l/min No values exist for ABS. As as a worst case assume ABS inh-rat rat = 100%/ ABSoral-human 50%]) Therefore, corrected LOAEL (dermal) = 19 x 0.2 x (100/50) = 7.6 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for other interspecies differences:
- 0.4
- Justification:
- See above justification
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.285 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 22.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- APPENDIX R. 8-8 Acute toxicity of Chapter R.8: Characterisation of dose [concentration]-response for human health states that dependant on the steepness of the dose-response curve for the repeated dose effects, the DNEL for acute toxicity could be set for a reference period of 15 minutes at 1-5 times the value (default 3) of the long-term DNEL. The steeper the dose-response relationship, the smaller the multiplying factor. This approach can be used to derive an indicative acute toxicity DNEL for substances NOAEL:7.6 mg/kg bw/day (see long term oral – systemic below for calculations) Default assessment factor: 3 Corrected NOAEL (oral, acute) = 22.8 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for other interspecies differences:
- 0.3
- Justification:
- NOAEL:7.6 mg/kg bw/day (see long term oral – systemic below for calculations) Default assessment factor: 3 Corrected NOAEL (oral, acute) = 22.8 mg/kg bw/day
- AF for intraspecies differences:
- 10
- Justification:
- intraspecies – general population
- AF for the quality of the whole database:
- 1
- Justification:
- Chapter R.8: Characterisation of dose [concentration]-response for human health
- Justification:
- It is considered that there is sufficient safety factors built into the extrapolations utilised to justify omission of this “uncertain” assessment factor
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
It should be noted that the substance will not be available to the general population in its given form; hence this section is essentially redundant. It is included here for completeness purposes.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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