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Diss Factsheets
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EC number: 200-839-4 | CAS number: 75-10-5
- 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:
- 7 035 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):
- 7.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 105 000 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52 762.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction of exposure duration in study (6 hrs/day, 5 days/week) to default worker exposure (8 hrs/day, 5 days/week);
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 m3).
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- already taken into consideration in the calculation of tle modified descriptor starting point.
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- 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; animal and humans breathe at a rate depending on their caloric requirements.
- AF for other interspecies differences:
- 1
- Justification:
- no other interspecies differences
- AF for intraspecies differences:
- 3
- Justification:
- 3 was considered to address the intraspecies extrapolation (worker subpopulation). As no effects were observed at the highest tested concentration (50000 ppm v/v) an intraspecies assessment factor of 3 is considered as amply sufficient.
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of the whole database
- AF for remaining uncertainties:
- 1
- Justification:
- no uncertainties remaining
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:
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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.
As the substance is a gas, oral and dermal routes of exposure are considered to be irrelevant, therefore no DNELs were derived for these routes.
As the substance is not classified for acute toxicity, according to the REACH “Guidance on information requirements and chemical safety assessment” (R.8.4.3.1), no acute / short-term exposure DNELs need to be derived.
For long-term exposure, a subchronic (13 weeks) toxicity study with rats is available. No adverse effects were observed at the highest concentration tested (50000 ppm (105000 mg/m3)).
As no local effects were observed in long-term exposure studies, no DNEL for local effects was derived.
The DNEL for long-term exposure - systemic effects for workers is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 105000 mg/m3 |
The highest concentration tested in the 13 week inhalation study with rats; no adverse effects have been observed. |
Step 2) Modification of starting point |
6/8
6.7 m3/10 m3 |
Correction of exposure duration in study (6 hrs/day, 5 days/week) to default worker exposure (8 hrs/day, 5 days/week);
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest (6.7 m3/10 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; animal and humans breathe at a rate depending on their caloric requirements. |
Intraspecies |
3 |
3 was considered to address the intraspecies extrapolation (worker subpopulation). As no effects were observed at the highest tested concentration (50000 ppm v/v) an intraspecies assessment factor of 3 is considered as amply sufficient. |
Exposure duration |
1 |
1 was considered to address the exposure duration extrapolation (from subchronic to chronic exposute). HFC-32 showed no adverse effects at the highest tested concentration (50000 ppm v/v) both in subacute and subchronic studies in rats. No dependence on exposure duration is observable. Thus, the assessment factor is not considered necessary. |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For workers |
105000 x 6/8 x 6.7/10 / (2.5 x 3 x 1 x 1 x 1) = 7035 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 750 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):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 105 000 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 18 750 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction of exposure duration in study (6 hrs/day) to default general population exposure (24 hrs/day) [1].
Correction ofdifferent exposure conditions (5 days/week in the subchronic study, 7 days/week of exposure for general population)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- Justification:
- already taken into consideration in the calculation of the modified dose descriptor starting point
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- 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; animal and humans breathe at a rate depending on their caloric requirements.
- AF for other interspecies differences:
- 1
- Justification:
- no other interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- As the general population includes the elderly and juvenile citizens, which are considered to be more sensitive, a default assessment factor of 10 is proposed in the REACH Guidance (R.8.4.3.1).
- AF for the quality of the whole database:
- 1
- Justification:
- good quality of the whole database
- 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:
- 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
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.
As the substance is a gas, oral and dermal routes of exposure are considered to be irrelevant, therefore no DNELs were derived for these routes.
As the substance is not classified for acute toxicity, according to the REACH “Guidance on information requirements and chemical safety assessment” (R.8.4.3.1), no acute / short-term exposure DNELs need to be derived.
For long-term exposure, a sub-chronic (13 weeks) toxicity study with rats is available. No adverse effects were observed at the highest concentration tested (50000 ppm (105000 mg/m3)).
As no local effects were observed in long-term exposure studies, no DNEL for local effects was derived.
The DNEL for long-term exposure - systemic effects for general population is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 105000 mg/m3 |
The highest concentration tested in the 90-d inhalation study with rats; no adverse effects have been observed. |
Step 2) Modification of starting point |
6/24 5/7 |
Correction of exposure duration in study (6 hrs/day) to default general population exposure (24 hrs/day)[1]. Correction of different exposure conditions (5 days/week in the subchronic study, 7 days/week of exposure for general population) |
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; animal and humans breathe at a rate depending on their caloric requirements. |
Intraspecies |
10 |
As the general population includes the elderly and juvenile citizens, which are considered to be more sensitive, a default assessment factor of 10 is proposed in the REACH Guidance (R.8.4.3.1). |
Exposure duration |
1 |
1 was considered to address the exposure duration extrapolation (from subchronic to chronic exposure). HFC-32 showed no adverse effects at the highest tested concentration (50000 ppm v/v) both in subacute and subchronic studies in rats. No dependence on exposure duration is observable. Thus the assessment factor is not considered necessary. |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For general population |
105000 x 6/24 x 5/7 / (2.5 x 10 x 1 x 1 x 1) =750 mg/m3 |
[1]Exposure duration for humans indirect exposed via the environment is assumed 24 hours per day, for consumers the exposure duration is assumed 1-24 hours per day (depending on the exposure scenario).
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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