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EC number: 815-966-6 | CAS number: 915972-17-7
- 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:
- 0.2 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 8.9 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.98 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to oral absorption data available, oral absorption rate in Fischer rats is ca. 70%, inhalation absorption was estimated to be 100%.
Considering the respiratory volume of the rat (0.38 m3/kg bw) and correction for activity driven differences of the respiratory volume in workers compared to workers in rest (6.7 m3/10 m3), the following calculation was done:
NOAEC corrected = 8.9 x (70/100) x (1/0.38) x (6.7/10) = 10.98 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL was used as starting point, therefore no additional factor is used.
- AF for differences in duration of exposure:
- 2
- Justification:
- The 1-year study in rats does not cover the whole life span, according to ECHA guidance R.8, an assessment factor of 2 is adequate.
- 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:
- 2.5
- Justification:
- Recommended AF for other interspecies differences / remaining uncertainties (ECHA guidance R.8)
- AF for intraspecies differences:
- 10
- Justification:
- Accounting for differences in worker population with regard to the effects observed.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical (guideline and GLP study).
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation is necessary since a repeated dose oral toxicity study is available. However, time scaling is required since animals were exposed for 6 hours whereas workers can be assumed to work for 8 hours per day. Therefore, the NOAEL was corrected according to:
NOAEL corrected = 1000 x (6h/8h) = 750 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL was used as starting point, 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), according to ECHA Guidance R.8
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used (ECHA Guidance R.8).
- AF for other interspecies differences:
- 2.5
- Justification:
- Recommended AF for other interspecies differences / remaining differences (ECHA Guidance R.8).
- AF for intraspecies differences:
- 10
- Justification:
- Accounting for differences in worker population with regard to the effects observed.
- 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:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The test material is not classified and labelled for acute systemic toxicity, according to Regulation (EC) No 1272/2008 (CLP).
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA.
Long term, systemic DNEL
Occupational exposure to the test substance occurs mainly via inhalation route, and may also occur via dermal route. Therefore two long-term DNELs are calculated for workers.
Long-term inhalation DNEL
There are no relevant experimental data on repeated exposure by inhalation, therefore the oral NOAEL of 8.9 mg/kg bw/d (determined in a 1-year study in F344 rats) was used as point of departure and converted into a corrected inhalation NOAEC of 10.98 mg/m3. Application of the appropriate assessment factors led to the determination of along-term systemic inhalation DNEL of 0.2 mg/m3.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 8.9 mg/kg bw/day |
as determined in 1-year study in rats |
Step 2) Modification of starting point |
70%/100%
0.38 m3/kg bw
6.7 m3/10 m3
|
Ratio of oral to inhalation absorption
Respiratory volume of a rat, corrected for 8 h exposure Correction for activity driven differences of respiratory volumes in workers compared to workers in rest |
Modified dose-descriptor |
NOAEC corrected = 8.9 * (70/100) * (1/0.38) * (6.7/10) = 10.98 mg/m3 |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
1 |
not required (according to ECHA guidance document R.8) |
Remaining differences |
2.5 |
accounting for interspecies differences (according to ECHA guidance document R.8) |
Intraspecies |
10 |
Accounting for differences in worker population |
Exposure duration |
2 |
1-year study as point of departure |
Dose response |
1 |
NOAEL is used as starting point |
Quality of database |
1 |
Guideline and GLP study |
DNEL |
Value |
|
|
10.98 / (1 x 2.5 x 10 x 2 x 1 x 1) =0.2 mg/m3 |
Since no local effects or acute toxicity was observed, the long-term inhalation DNEL of 0.2 mg/m3 is considered sufficient to cover inhalation effects.
Long-term dermal DNEL
For derivation of the long-term systemic dermal DNEL, the dermal NOAEL of 1000 mg/kg bw/d (as determined in a dermal 28-day study in rats) was taken as a basis. This was converted into a corrected dermal NOAEL of 750 mg/kg bw/d based on time extrapolation. Applying all assessment factors, a dermal long-term DNEL for systemic effects of 1.25 mg/kg bw/d is derived.
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 1000 mg/kg bw/day |
as determined in dermal 28-day study in rats |
Step 2) Modification of starting point |
6h/8h |
time scaling for standard 8 hour shift of workers (experimental exposure: 6h) |
Modified dose-descriptor |
NOAEL corrected dermal = 750 mg/kg bw/d |
|
Step 3) Assessment factors |
|
|
Allometric scaling |
4 |
according to ECHA guidance R.8 |
Remaining differences |
2.5 |
according to ECHA guidance R.8 |
Intraspecies |
10 |
according to ECHA guidance R.8 |
Exposure duration |
6 |
28-day study as point of departure |
Dose response |
1 |
NOAEL is used as starting point |
Quality of database |
1 |
Guideline and GLP study |
DNEL |
Value |
|
|
750 / (4 x 2.5 x 10 x 6 x 1 x 1) =1.25 mg/kg bw/day |
Since no local effects or acute toxicity was observed, the long-term dermal DNEL of 1.25 mg/kg bw/d is considered sufficient to cover dermal effects.
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
General
General population is not intended to be exposed to test item via inhalation, oral or dermal route. Therefore, no DNEL (long-term, inhalation and dermal exposure) is derived for general population. As the test item has no bioaccumulation potential no risk assessment for secondary poisoning is required for the general population.
References
(not included as endpoint study record)
- ECHA (2014) Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2.1 ECHA-2010 -G-19 –EN.
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