Registration Dossier
Registration Dossier
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EC number: 203-455-5 | CAS number: 107-03-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
2.5 (interspecies - for systemic effects); 5 (intraspecies - for workers); 2 (exposure duration - subchronic to chronic)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
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:
- 2.06 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
4 (interspecies - allometric scaling (rat)); 2.5 (interspecies - for systemic effects); 5 (intraspecies - for workers); 2 (exposure duration - subchronic to chronic)
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.53 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- other: EC3
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 10
- AF for intraspecies differences:
- 1
- AF for remaining uncertainties:
- 1
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute/Short-term exposure – Systemic effects:
1) Dermal DN(M)EL:
A DNEL for short term duration (short term event, peak exposure) will not need to be derived in the case where an acute toxicity hazard (leading to C&L) has not been identified.
2) Inhalation DN(M)EL:
High peak exposure is unlikely considering that propane-1 -thiol is highly malodorous. Therefore, a DNEL is not derived.
Acute/Short-term exposure – Local effects:
1) Dermal DN(M)EL:
The substance is classified for skin sensitisation therefore an acute dermal DNEL is derived from the read-across EC3 value.
2) Inhalation DN(M)EL:
High peak exposure is unlikely considering that propane-1 -thiol is highly malodorous. Therefore, a DNEL is not derived.
Long-term exposure – Systemic effects:
1) Dermal DN(M)EL:
The dermal DNEL has been derived based on read-across of a 90-day inhalation study with 2-methylpropane-2 -thiol (TBM).
Step 1) Relevant dose-descriptor |
NOAEC6h/rat: 0.721 mg/L |
Step 2) Modification of starting point |
Conversion for units: 0.721 mg/L x 1000 = 721 mg/m3 |
Correction of rat inhalation NOAEC to rat dermal NOAEL – correction for respiratory volume and for difference in absorption rates |
NOAELrat: 274 mg/kg bw/day (= 721 x 0.38 x 1) Assumption: Based on ECHA guidance (Chapter R.8) no default factor was applied for differences in absorption in rats and humans and therefore absorption was assumed to be 100% via the dermal and inhalation route |
Correction of exposure duration in study |
(6 hrs/day, 5 days/week) to default worker exposure (8 hrs/day, 5 days/ week) Corrected NOAEL = 205.5 mg/kg bw/day (=274 x 6/8) |
Step 3) Assessment factors |
ECHA assessment factors used |
Interspecies (allometric scaling) |
4 (rat) |
Interspecies |
2.5 (for systemic effects) |
Intraspecies |
5 (for worker population) |
Exposure duration |
2 (for sub-chronic to chronic) |
Dose response |
1 |
Quality of database |
1 |
Total Assessment Factors |
100 |
Worker DNELlong-term for dermal route -Systemic |
2.06 mg/kg bw/day (= 205.5 x 1/(4 x 2.5 x 5 x 2 x 1 x 1)) |
2) Inhalation DN(M)EL:
The inhalation DNEL has been derived based on read-across of a 90-day inhalation study with 2-methylpropane-2 -thiol (TBM).
Step 1) Relevant dose-descriptor |
NOAEC6h/rat: 0.721 mg/L |
| Step 2) Modification of starting point | Conversion for units:0.721 mg/L x 1000 = 721 mg/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 m3Corrected NOAEC = 362.3 mg/m3(= 721 x 6/8 x 6.7/10) |
| Step 3) Assessment factors | ECHA assessment factors used |
| Interspecies | 2.5 (for systemic effects) |
| Intraspecies | 5 (for workers) |
| Exposure duration | 2 (for sub-chronic to chronic) |
| Dose response | 1 |
| Quality of database | 1 |
| Total Assessment Factors | 25 |
| Worker DNELlong-term for inhalation route -Systemic | 14.5 mg/m3 (= 362.3 x 1/(2.5 x 5 x 2 x 1 x 1)) |
Long-term exposure – Local effects:
1) Dermal DN(M)EL:
No-threshold effect and/or no dose-response information available.
2) Inhalation DN(M)EL:
The inhalation DNEL has been derived based on read-across of a 90-day inhalation study with 2-methylpropane-2 -thiol (TBM).
Step 1) Relevant dose-descriptor |
NOAEC6h/rat: 0.37 mg/L |
| Step 2) Modification of starting point | Conversion for units:0.37 mg/L x 1000 = 370 mg/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 | ECHA assessment factors used |
| Interspecies | 1 (for local effects) |
| Intraspecies | 5 (for workers) |
| Exposure duration | 2 (for sub-chronic to chronic) |
| Dose response | 1 |
| Quality of database | 1 |
| Total Assessment Factors | 10 |
| Worker DNELlong-term for inhalation route -Local | 18.6 mg/m3 (= 370 x 6/8 x 6.7/10 x 1/(1 x 5 x 2 x 1 x 1)) |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.57 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Dose descriptor:
- NOAEC
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.74 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
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
Acute/Short-term exposure – Systemic effects:
1) Dermal DN(M)EL:
A DNEL for short term duration (short term event, peak exposure) will not need to be derived in the case where an acute toxicity hazard (leading to C&L) has not been identified.
2) Inhalation DN(M)EL:
Exposure is unlikely due to the highly malodorous nature of 2 -methylpropane-2-thiol. Therefore, a DNEL is not derived.
Acute/Short-term exposure – Local effects:
1) Dermal DN(M)EL:
There is no potential for dermal exposure of consumers therefore a DNEL is not derived.
2) Inhalation DN(M)EL:
Exposure is unlikely due to the highly malodorous nature of 2 -methylpropane-2-thiol. Therefore, a DNEL is not derived.
Long-term exposure – Systemic effects:
1) Dermal DN(M)EL:
No-threshold effect and/or no dose-response information available.
2) Inhalation DN(M)EL:
The inhalation DNEL has been derived based on read-across of a 90-day inhalation study with 2-methylpropane-2 -thiol (TBM).
Step 1) Relevant dose-descriptor |
NOAEC6h/rat: 0.721 mg/L |
| Step 2) Modification of starting point | Conversion for units:0.721 mg/L x 1000 = 721 mg/m3 |
| Correction of exposure duration in study | (6 hrs/day, 5 days/week) to default general population exposure (24 hrs/day, 7 days/ week)Corrected NOAEC = 128.7 mg/m3(= 721 x 6/24 x 5/7) |
| Step 3) Assessment factors | ECHA assessment factors used |
| Interspecies | 2.5 (for systemic effects) |
| Intraspecies | 10 (for general population) |
| Exposure duration | 2 (for sub-chronic to chronic) |
| Dose response | 1 |
| Quality of database | 1 |
| Total Assessment Factors | 50 |
| General Population DNELlong-term for inhalation route -Systemic | 2.57 mg/m3 (= 128.7 x 1/(2.5 x 10 x 2 x 1 x 1)) |
3) Oral DN(M)EL:
The oral DNEL has been derived based on read-across of a 90-day inhalation study with 2-methylpropane-2 -thiol (TBM).
Step 1) Relevant dose-descriptor |
NOAEC6h/rat: 0.721 mg/L |
| Step 2) Modification of starting point | Conversion for units:0.721 mg/L x 1000 = 721 mg/m3 |
| Correction of rat inhalation NOAEC to rat oral NOAEL – correction for respiratory volume and for difference in absorption rates | NOAELrat: 829.15 mg/kg bw/day (= 721 x 1.15 x 1) Assumption: Based on ECHA guidance (Chapter R.8) no default factor was applied for differences in absorption in rats and humans and therefore absorption was assumed to be 100% via the oral and inhalation route |
| Correction of exposure duration in study | (6 hrs/day, 5 days/week) to default general population exposure (24 hrs/day, 7 days/ week)Corrected NOAEL = 148.04 mg/kg bw/day(= 829.15 x 6/24 x 5/7) |
| Step 3) Assessment factors | ECHA assessment factors used |
| Interspecies (allometric scaling) | 4 (rat) |
| Interspecies | 2.5 (for systemic effects) |
| Intraspecies | 10 (for general population) |
| Exposure duration | 2 (for sub-chronic to chronic) |
| Dose response | 1 |
| Quality of database | 1 |
| Total Assessment Factors | 200 |
| General Population DNELlong-term for oral route -Systemic | 0.74 mg/kg bw/day (= 148.04 x 1/(4 x 2.5 x 10 x 2 x 1 x 1)) |
Long-term exposure – Local effects:
1) Dermal DN(M)EL:
No-threshold effect and/or no dose-response information available.
2) Inhalation DN(M)EL:
The inhalation DNEL has been derived based on read-across of a 90-day inhalation study with 2-methylpropane-2 -thiol (TBM).
Step 1) Relevant dose-descriptor |
NOAEC6h/rat: 0.37 mg/L |
| Step 2) Modification of starting point | Conversion for units:0.37 mg/L x 1000 = 370 mg/m3 |
| Correction of exposure duration in study | (6 hrs/day, 5 days/week) to default general population exposure (24 hrs/day, 7 days/ week) |
| Step 3) Assessment factors | ECHA assessment factors used |
| Interspecies | 1 (for local effects) |
| Intraspecies | 10 (for general population) |
| Exposure duration | 2 (for sub-chronic to chronic) |
| Dose response | 1 |
| Quality of database | 1 |
| Total Assessment Factors | 20 |
| General PopulationDNELlong-term for inhalation route -Local | 3.30 mg/m3 (= 370 x 6/24 x 5/7 x 1/(1 x 10 x 2 x 1 x 1)) |
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