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EC number: 401-000-7 | CAS number: 198153-83-2
- 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:
- 2.35 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Only dermal route available
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation to chronic exposure based on a sub-acute toxicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation to chronic exposure based on a sub-acute toxicity study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling in case of rat to human extrapolation.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
- Justification:
- Standard assessment factor
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:
- low hazard (no threshold derived)
Additional information - workers
According to the REACH Guidance on information requirements and chemical safety assessment, a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
Short-term toxicity
According to the REACH guideline (R8, Appendix R 8-8), a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential risk for high peak exposures. Since the substance is not classified for acute dermal, inhalation, and oral toxicity, no short-term DNELs needs to be derived for these routes of exposure. The substance is also not classified as irritating to the skin and not sensitizing. Therefore no derivation of the DNEL for local dermal effects and for sensitization is needed. No data is available whether the test substance could cause irritation to the respiratory track and therefore no DNEL could be derived
Long-term toxicity
A subacute (28-days) dermal toxicity study is available in rats. In this study a NOAEL of 1000 mg/kg bw/day was established for systemic effects and a NOAEL of 40 mg/kg bw/day for local effect. No treatment related effects were observed on mortality, clinical signs, food consumption, body weight, ophthalmoscopic examinations, clinical laboratory investigations, and organ weights. Treatment-related gross and microscopic findings were observed at the application site at dose-dependent incidence and severity. Macroscopically, the lesions consisted in sores and scabs of varying size,microscopically, minimal to severe inflammation with slight to marked acanthosis was observed. Since treatment-related dose depended alterations were observed macroscopically and microscopically in the treated skin, the NOAEL for local effects was determined to be 40 mg/kg/bw, while the NOAEL for systemic effects was determined to be 1000 mg/kg bw/day. However, the administered test substance was dissolved in 4% aqueous sodium CMC and placed on the skin under occlusive dressing for 6 hours per day. The combination of exposure to a gel like formulation and the prevention of evaporation of moisture from the skin surface due to the occlusive condition will result in skin irritation regardless of the substance used.
Since only a sub-acute dermal toxicity study is available a route-to-route extrapolation is needed to derive the systemic DNELs for oral and inhalation route regarding long-term exposure.
According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information on the starting route, to include a factor on a case-by-case basis. The low log Pow (<-1) value and the high water solubility (>10000 mg/L) suggest that the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for these substances will be low. On the assumption that the physicochemical properties of the test substance reduces the absorption of the test substance, a factor of 10 is introduced when performing dermal to inhalation and dermal to oral extrapolation.
Worker DNELs
Long-term
Long-term – dermal, systemic effects (based on sub-acute dermal toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects observed at any dose level. |
Step 2) Modification of starting point |
- |
- |
Step 3) Assessment factors |
|
|
Interspecies |
4 x 2.5 |
Assessment factor for allometric scaling. |
Intraspecies |
5 |
Default assessment factor for workers |
Exposure duration |
6 |
Extrapolation to chronic exposure based on a sub-acute toxicity study |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
1000 / (4 x 2.5 x 5 x 6 x 1 x 1) =3.33 mg/kg bw/day |
Long-term – inhalation, systemic effects (based on sub-acute dermal toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects observed at any dose level. |
Step 2) Modification of starting point |
10
0.38 m3/kg bw
6.7 m3/10 m3 |
On the assumption that the physicochemical properties of the test substance reduces the absorption of the test substance, a factor of 10 is introduced when performing dermal to inhalation extrapolation.
Standard respiratory volume of a rat, corrected for 8 h exposure, as proposed in the REACH Guidance on information requirements and chemical safety assessment (R.8.4.2).
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest. |
Modified dose-descriptor |
1000 / 10 / 0.38 x (6.7/10) = 176.3 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
2.5 |
For inhalation studies only a factor 2.5 is used, and no correction is made for differences in body size, because extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements. |
Intraspecies |
5 |
Default assessment factor for workers |
Exposure duration |
6 |
Extrapolation to chronic exposure based on a sub-acute toxicity study |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
176.3 / (2.5 x 5 x 6 x 1 x 1) =2.35 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 580 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Only dermal route available
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation to chronic exposure based on a sub-acute toxicity study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation to chronic exposure based on a sub-acute toxicity study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling in case of rat to human extrapolation.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default assessment factor
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:
- 167 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Only dermal route available
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation to chronic exposure based on a sub-acute toxicity study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for allometric scaling in case of rat to human extrapolation.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
According to the REACH Guidance on information requirements and chemical safety assessment, a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
Short-term toxicity
According to the REACH guideline (R8, Appendix R 8-8), a DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential risk for high peak exposures. Since the substance is not classified for acute dermal, inhalation, and oral toxicity, no short-term DNELs needs to be derived for these routes of exposure. The substance is also not classified as irritating to the skin and not sensitizing. Therefore no derivation of the DNEL for local dermal effects and for sensitization is needed. No data is available whether the test substance could cause irritation to the respiratory track and therefore no DNEL could be derived
Long-term toxicity
A subacute (28-days) dermal toxicity study is available in rats. In this study a NOAEL of 1000 mg/kg bw/day was established for systemic effects and a NOAEL of 40 mg/kg bw/day for local effect. No treatment related effects were observed on mortality, clinical signs, food consumption, body weight, ophthalmoscopic examinations, clinical laboratory investigations, and organ weights. Treatment-related gross and microscopic findings were observed at the application site at dose-dependent incidence and severity. Macroscopically, the lesions consisted in sores and scabs of varying size, microscopically, minimal to severe inflammation with slight to marked acanthosis was observed. Since treatment-related dose depended alterations were observed macroscopically and microscopically in the treated skin, the NOAEL for local effects was determined to be 40 mg/kg/bw, while the NOAEL for systemic effects was determined to be 1000 mg/kg bw/day. However, the administered test substance was dissolved in 4% aqueous sodium CMC and placed on the skin under occlusive dressing for 6 hours per day. The combination of exposure to a gel like formulation and the prevention of evaporation of moisture from the skin surface due to the occlusive condition will result in skin irritation regardless of the substance used. Since only a sub-acute dermal toxicity study is available a route-to-route extrapolation is needed to derive the systemic DNELs for oral and inhalation route regarding long-term exposure.
According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route-specific information on the starting route, to include a factor on a case-by-case basis.The low log Pow (<-1) value and the high water solubility (>10000 mg/L) suggest that the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for these substances will be low.On the assumption that the physicochemical properties of the test substance reduces the absorption of the test substance, a factor of 10 is introduced when performing dermal to inhalation and dermal to oral extrapolation.
General population DNELs
Long-term
Long-term – dermal, systemic effects (based on sub-acute dermal toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects observed at any dose level. |
Step 2) Modification of starting point |
- |
- |
Step 3) Assessment factors |
|
|
Interspecies |
4 x 2.5 |
Assessment factor for allometric scaling. |
Intraspecies |
10 |
Default assessment |
Exposure duration |
6 |
Extrapolation to chronic exposure based on a sub-acute toxicity study |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
1000 / (4 x 2.5 x 10 x 6 x 1 x 1) =1.67 mg/kg bw/day |
Long-term – inhalation, systemic effects (based on sub-acute dermal toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects observed at any dose level. |
Step 2) Modification of starting point |
10
1.15 m3/kg bw
|
On the assumption that the physicochemical properties of the test substance reduces the absorption of the test substance, a factor of 10 is introduced when performing dermal to inhalation extrapolation.
Standard respiratory volume of a rat, corrected for 24 h exposure, as proposed in the REACH Guidance on information requirements and chemical safety assessment (R.8.4.2). |
Modified dose-descriptor |
1000 / 10 / 1.15 = 87.0 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
2.5 |
For inhalation studies only a factor 2.5 is used, and no correction is made for differences in body size, because extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans; animals and humans breathe at a rate depending on their caloric requirements. |
Intraspecies |
10 |
Default assessment factor |
Exposure duration |
6 |
Extrapolation to chronic exposure based on a sub-acute toxicity study |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
87.0 / (2.5 x 10 x 6 x 1 x 1) =580 µg/m3 |
Long-term – oral, systemic effects (based on sub-acute dermal toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
No adverse effects observed at any dose level. |
Step 2) Modification of starting point |
10 |
On the assumption that the physicochemical properties of the test substance reduces the absorption of the test substance, a factor of 10 is introduced when performing dermal to oral extrapolation. |
Modified dose-descriptor |
1000 / 10 = 100 mg/kg bw/day |
|
Step 3) Assessment factors |
|
|
Interspecies |
4 x 2.5 |
Assessment factor for allometric scaling. |
Intraspecies |
10 |
Default assessment factor |
Exposure duration |
6 |
Extrapolation to chronic exposure based on a sub-chronic toxicity study |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
100 / (4 x 2.5 x 10 x 6 x 1 x 1) =167 µg/kg bw/day |
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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