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EC number: 418-000-8 | CAS number: 163062-28-0 BLEU REN 20
- 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:
- 11.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
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:
- 33.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
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:
- medium 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 needs to be derived. 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) oral toxicity study is available in rats. In this study a NOAEL of 1000 mg/kg bw/day was established. In none of the dose groups treatment related effects were observed on mortality, clinical signs, body weight, food consumption, ophthalmic examinations, clinical pathology investigations, and organ weight. Only an abnormal blue color was observed at the macroscopic examination in several organs and tissues mainly of animals receiving 1000 mg/kg/day. Blue pigmentation was observed microscopically in the kidneys and testes of treated animals receiving 1000 mg/kg/day, sacrificed after 4 weeks of treatment. This finding was still evident after two week of recovery. This coloration is considered to be a sign of test substance absorption, distribution and excretion. Therefore, a NOAEL of 1000 mg/kg bw was determined. Since only a sub-acute oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation route.
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 default factor of 2 in the case of oral-to-inhalation extrapolation. This approach will be taken forward to DNEL derivation.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.In the available acute dermal study no effects were observed (RCC 2001). In the absence of route-specific information a ratio of 0.1 for oral to dermal absorption is provisionally suggested for the risk assessment of the substance, based on its physico-chemical properties.
Worker DNELs
Long-term
Long-term – dermal, systemic effects (based on sub-acute oral 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 |
0.1 |
Based on low log Kow and very high water solubility, dermal absorption is expected to be low. A ratio of 0.1 for oral to dermal absorption is therefore provisionally suggested for DNEL derivation. |
Modified dose-descriptor |
1000 / 0.1 = 10000 mg/kg bw/day |
|
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 |
|
|
10000 / (4 x 2.5 x 5 x 6 x 1 x 1) = 33.3 mg/kg bw/day |
Long-term – inhalation, systemic effects (based on sub-acute oral 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 |
2
0.38 m3/kg bw
6.7 m3/10 m3 |
The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 2 in case of oral 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 / 2 / 0.38 x (6.7/10) = 881.6 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 |
|
|
881.6 / (2.5 x 5 x 6 x 1 x 1) =11.8 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
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:
- 16.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
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:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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 needs to be derived. 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) oral toxicity study is available in rats. In this study a NOAEL of 1000 mg/kg bw/day was established. In none of the dose groups treatment related effects were observed on mortality, clinical signs, body weight, food consumption, ophthalmic examinations, clinical pathology investigations, and organ weight. Only an abnormal blue color was observed at the macroscopic examination in several organs and tissues mainly of animals receiving 1000 mg/kg/day. Blue pigmentation was observed microscopically in the kidneys and testes of treated animals receiving 1000 mg/kg/day, sacrificed after 4 weeks of treatment. This finding was still evident after two week of recovery. This coloration is considered to be a sign of test substance absorption, distribution and excretion. Therefore, a NOAEL of 1000 mg/kg bw was determined. Since only a sub-acute oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation route.
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 default factor of 2 in the case of oral-to-inhalation extrapolation. This approach will be taken forward to DNEL derivation.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.In the available acute dermal study no effects were observed (RCC 2001). In the absence of route-specific information a ratio of 0.1 for oral to dermal absorption is provisionally suggested for the risk assessment of the substance, based on its physico-chemical properties.
General population DNELs
Long-term
Long-term – dermal, systemic effects (based on sub-acute oral 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 |
0.1 |
Based on low log Kow and very high water solubility, dermal absorption is expected to be low. A ratio of 0.1 for oral to dermal absorption is therefore provisionally suggested for DNEL derivation. |
Modified dose-descriptor |
1000 / 0.1 = 10000 mg/kg bw/day |
|
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 |
|
|
10000 / (4 x 2.5 x 10 x 6 x 1 x 1) = 16.7 mg/kg bw/day |
Long-term – inhalation, systemic effects (based on sub-acute oral 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 |
2
1.15 m3/kg bw
|
The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 2 in case of oral 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 / 2 / 1.15 = 434.8 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 |
|
|
434.8 / (2.5 x 10 x 6 x 1 x 1) = 2.9 mg/m3 |
Long-term – oral, systemic effects (based on sub-acute oral 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 factor |
Exposure duration |
6 |
Extrapolation to chronic exposure based on a sub-chronic 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 |
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.