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Diss Factsheets
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EC number: 200-838-9 | CAS number: 75-09-2
- 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:
- 176 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: MAK assessmment (2016)
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 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 582 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Several studies available
- AF for dose response relationship:
- 1
- Justification:
- dose-response available
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 5
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- database OK
- 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
DNEL Workers via the dermal route
Systemic Long term exposure
From the available data set, regarding the oral route of exposure a chronic NOAEL of 6 mg/kg bw/day based on liver and haematological effects (LOAEL of 52 mg/kg bw/day) is selected as most critical one. This NOAEL is used as starting point for the DNEL derivation.
Long-term – dermal, systemic effects (based on 2-year oral toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL oral: 6 mg/kg bw/day |
liver and haematological effects |
Step 2) Modification of starting point |
NOAEL oral 6 mg/kg bw/day*(97/1) = corrected NOAEL dermal 582 mg/kg bw/day |
|
Step 3) Assessment factors |
||
Interspecies |
4 x 2.5 |
Assessment factor for allometric scaling and remaining uncertainties. |
Intraspecies |
5 |
Default assessment factor |
Exposure duration |
1 |
No factor for exposure duration is needed since the NOAEL was derived in a chronic study. |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
582 / (4 x 2.5 x 5 x 1 x 1 x 1) =12 mg/kg bw/day |
*Oral absorption set at 97% (see above); dermal absorption set at 1% under non-occlusive conditions
Guidance by e.g., the exposure model ECETOC TRA, indicates that although EASE (and hence ECETOC TRA) provides an exposure estimate for high volatile liquids (i.e., with a vapour pressure > 10 kPa), in practice such exposure would not occur in the case of very volatile substances as the substance would never be in contact with the skin for a sufficient period of time (due to fast evaporation) to enable significant dermal permeation to occur (Patel et al., 2002). Therefore, in the case of nonocclusive conditions, this means that any quantitative estimate may be set at the level of PROC 1 and 3 for substances having a vapour pressure greater than ca. 30 kPa (ECETOC TRA vs 3). Dichloromethane has a vapour pressure of 58.4 kPa at 25ºC and as such is highly volatile.
PROC 1 results in a predicted dermal exposure of 0.03 mg/kg bw/day, whereas PROC 3 (worst case) results in a predicted dermal exposure of 0.69 mg/kg bw/day, thus indicating safe use for the worker.
Regarding absorption through the skin, we have already advised in each exposure scenario: ‘Avoid all skin contact with product, clean up contamination/spills as soon as they occur. Wear gloves (tested to EN374) if hand contamination is likely, and wash off any skin contamination immediately. Provide basic employee training to prevent / minimise exposures and to report any skin problems that may develop.’ In addition the substance is to be labelled with ‘P280: Wear protective gloves/protective clothing/eye protection/face protection.’
12 mg/kg bw/day, will be used in the risk characterisation.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 44 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: based on MAK (2016)
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:
- DNEL (Derived No Effect Level)
- Value:
- 5.82 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 582 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Several studies available
- AF for dose response relationship:
- 1
- Justification:
- dose-response available
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 10
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- database OK
- 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.06 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
not applicable (oral study)
- AF for dose response relationship:
- 1
- Justification:
- dose-response available
- AF for differences in duration of exposure:
- 1
- Justification:
- chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 10
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- database OK
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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
DNEL General population via the dermal route
Systemic Long terme exposure
From the available data set, regarding the oral route of exposure a chronic NOAEL of 6 mg/kg bw/day based on liver and haematological effects (LOAEL of 52 mg/kg bw/day) is selected as most critical one. This NOAEL is used as starting point for the DNEL derivation.
Long-term – dermal, systemic effects (based on 2-year oral toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL oral: 6 mg/kg bw/day |
liver and haematological effects |
Step 2) Modification of starting point |
NOAEL oral 6 mg/kg bw/day*(97/1) = corrected NOAEL dermal 582 mg/kg bw/day |
|
Step 3) Assessment factors |
||
Interspecies |
4 x 2.5 |
Assessment factor for allometric scaling and remaining uncertainties. |
Intraspecies |
10 |
Default assessment factor |
Exposure duration |
1 |
No factor for exposure duration is needed since the NOAEL was derived in a chronic study. |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
582 / (4 x 2.5 x 10 x 1 x 1 x 1) =5.82 mg/kg bw/day |
*Oral absorption set at 97% (see above); dermal absorption set at 1% under non-occlusive conditions (for more information see above in discussion for workers).
5.82 mg/kg bw/day, will be used in the risk characterisation.
DNEL General population via the oral route
Systemic Long termexposure
From the available data set,regarding the oral route of exposure a chronic NOAEL of 6 mg/kg bw/day based on liver and haematological effects (LOAEL of 52 mg/kg bw/day) is selected as most critical one. This NOAEL is used as starting point for the DNEL derivation.
Long-term – oral, systemic effects (based on 2-year oral toxicity study with rats)
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 6 mg/kg bw/day |
liver and haematological effects |
Step 2) Modification of starting point |
- |
not applicable |
Step 3) Assessment factors |
|
|
Interspecies |
4 x 2.5 |
Assessment factor for allometric scaling and remaining uncertainties. |
Intraspecies |
10 |
Default assessment factor |
Exposure duration |
1 |
No factor for exposure duration is needed since the NOAEL was derived in a chronic study. |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
|
6 / (4 x 2.5 x 10 x 1 x 1 x 1) =0.06 mg/kg bw/day |
0.06 mg/kg bw/day, will be used in the risk characterisation.
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.