Registration Dossier
Registration Dossier
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EC number: 219-854-2 | CAS number: 2551-62-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6 074 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 60 737 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Not required, starting point is NOAEC.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation to chronic exposure based on a sub-chronic toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route. 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.
- AF for other interspecies differences:
- 1
- Justification:
- No additional interspecies factor is applied as:
- regarding toxicokinetics: no metabolic differences between rats and humans are expected for SF6 based on the substance chemical inertness and rapid excretion in unmetabolised form;
- regarding toxicodynamics: no effects were observed up to the relatively very high concentration of 120870 mg/m3. In addition, no differences are expected based on the chemical inertness of SF6. - AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Database of appropriate quality
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainty 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
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 sulphur hexafluoride 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 a 90-day repeated dose toxicity study by the inhalation route is available. In this study, no adverse effects were observed in rats at the highest concentration tested (NOAEC of 120870 mg/m3, corresponding to a target limit concentration of 20000 ppm). This value will be used to derive a DNEL for long-term exposure. The substance is not genotoxic, not carcinogenic, and is not a reproductive or developmental toxicant. Therefore, no DNELs will be derived for these endpoints, i.e., the long-term DNEL is also considered sufficient to protect against these effects.
The DNEL for long-term exposure - local/systemic effects for workers is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEC: 120870 mg/m3 |
The highest concentration in the subchronic toxicity study with rats; no adverse effects were 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 |
1 |
No additional interspecies factor is applied as: - regarding toxicokinetics: no metabolic differences between rats and humans are expected for SF6 based on the substance chemical inertness and rapid excretion in unmetabolised form; - regarding toxicodynamics: no effects were observed up to the relatively very high concentration of 120870 mg/m3. In addition, no differences are expected based on the chemical inertness of SF6. |
Intraspecies |
5 |
Default assessment factor |
Exposure duration |
2 |
Subchronic to chronic |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
For workers |
120870 x 6/8 x 6.7/10 / (1 x 5 x 2 x 1 x 1) = 6074 mg/m3 (1008 ppm) |
|
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 511 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):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 30 218 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Not required, starting point is NOAEC.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation to chronic exposure based on a sub-chronic toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route. 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.
- AF for other interspecies differences:
- 1
- Justification:
- No additional interspecies factor is applied as:
- regarding toxicokinetics: no metabolic differences between rats and humans are expected for SF6 based on the substance chemical inertness and rapid excretion in unmetabolised form;
- regarding toxicodynamics: no effects were observed up to the relatively very high concentration of 120870 mg/m3. In addition, no differences are expected based on the chemical inertness of SF6. - AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Database of appropriate quality,
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainty 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
The DNEL for long-term exposure - systemic effects for the general population is derived as follows:
Description | Value | Remark |
Step 1) Relevant dose-descriptor | NOAEC: 120870 mg/m3 | The highest concentration in the subacute toxicity study with rats; no adverse effects were observed |
Step 2) Modification of starting point | 6/24
| Correction of exposure duration in study (6 hrs/day, 5 days/week) to default general population exposure (24 hrs/day) [1] |
Step 3) Assessment factors |
|
|
Interspecies | 1 | No additional interspecies factor is applied as: - regarding toxicokinetics: no metabolic differences between rats and humans are expected for SF6 based on the substance chemical inertness and rapid excretion in unmetabolised form; - regarding toxicodynamics: no effects were observed up to the relatively very high concentration of 120870 mg/m3. In addition, no differences are expected based on the chemical inertness of SF6. |
Intraspecies | 10 | Default assessment factor for general population |
Exposure duration | 2 | Subchronic to chronic |
Dose response | 1 |
|
Quality of database | 1 |
|
DNEL | Value | |
For the general population | 120870 x 6/24 / (1 x 10 x 2 x 1 x 1) = 1511 mg/m3 (250 ppm) | |
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