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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 200-867-7 | CAS number: 75-38-7
- 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
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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:
- 1 045 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
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, data from subchronic (13 weeks/90 days) and combined chronic toxicity/carcinogenicity (104 weeks) studies with rats and mice are available. In the 13 week studies, no target organs were consistently identified.
In the combined chronic toxicity/carcinogenicity studies no adverse effects were observed at the highest concentration tested (10000 ppm (26000 mg/m3)).
In this hazard evaluation, the primary studies for DNEL derivation are the chronic toxicity/carcinogenicity studies (TNO (1991) and Bio/dynamics Inc. (1991)). They are preferred above the well-conducted 2 weeks and 13 weeks/90 days studies of Bio/dynamics Inc. (1988; 1989) based on the study duration (chronic vs. semichronic/subacute). They are also preferred above the male/female fertility study in which no effects were observed up to the highest concentration tested (7000 ppm (18000 mg/m3)). As in this fertility study animals were exposed up to 18 weeks and limited histopathology has been performed (study focus was on fertility parameters, not on general toxicity parameters after chronic exposure), this study is not considered as the key study for DNEL derivation.
The two chronic key studies were performed according to currently accepted guidelines and GLP standards. It is believed that the overall quality, detailed description and length of the studies, provides a sound basis for determining the hazard of vinylidene fluoride. Many of the subchronic studies do not have the level of detail provided in the more recent GLP chronic studies. In addition, many of the effects observed in the subchronic studies were not considered to be dose related or transient and in many cases not related to organ pathology. The overall weight of evidence regarding the studies and the inability to reproduce the same effects in the chronic GLP studies should also be taken into consideration.
In conclusion, the NOAEL (10000 ppm (26000 mg/m3) from the chronic toxicity studies is selected for DNEL derivation for systemic effects.
As no local effects were observed in the long-term inhalation exposure studies, no DNEL for local effects was derived.
The DNEL for long-term inhalation exposure - systemic effects for workers is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL:26000mg/m3 |
The highest dose concentration in the combined chronic toxicity/carcinogenicity study with rats; no adverse effects 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 |
5 |
A default assessment factor for workers, as proposed in the REACH Guidance (R.8.4.3.1) |
Exposure duration |
1 |
No extrapolation of exposure duration is required, as the NOAEL is from a chronic study |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For workers |
26000 x 6/8 x 6.7/10 / (2.5 x 5 x 1 x 1 x 1) =1045 mg/m3 |
The worker DNEL value derived for chronic inhalation would have to be adapted in case of a different shift system (= daily exposure time). In that case the amended DNEL would results in virtually the same value under the condition that the weekly exposure time would be almost identical.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 260 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The DNEL for long-term inhalation exposure - systemic effects for the general population is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 26000mg/m3 |
The highest concnetration tested in the combined chronic toxicity/carcinogenicity study with rats; no adverse effects observed |
Step 2) Modification of starting point |
6/24 |
Correction of exposure duration in study (6 hrs/day) to default general population exposure (24 hrs/day)[1]. |
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 |
No extrapolation of exposure duration is required, as NOAEL is based on the chronic study |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For general population |
26000 x 6/24 / (2.5 x 10 x 1 x 1 x 1) =260 mg/m3 |
[1] Since the general population covers the population living around the plant, a correction factor for an exposure duration of 24 hours is applied. There is no exposure to consumers since the polymer does not contain any free monomer and the polymer is still used for industrial uses and never into contact with the general consumers.
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.
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