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EC number: 460-100-9 | CAS number: 342573-75-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 218.98 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 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
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 238.85 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The primary route of anticipated industrial exposure to 1-ethyl-3-methylimidazolium ethylsulfate is via skin contact. Given its very low vapour pressure at room temperature, inhalation of 1-ethyl-3-methylimidazolium ethylsulfate vapours is not likely to be high. However, exposition to aerosols or droplets of an inhalable size cannot be ruled out.
Consumer exposure via the oral route is to be considered additionally.
Since the 1-Ethyl-3-methylimidazolium ethylsulfate is not classified for acute systemic/local toxicity, no acute systemic/local DNEL is derived. A slight irritating potential was observed in the acute oral exposure after 24 h exposure under occlusive conditions (NOTOX B.V., 2005), but was not confirmed in the irritation study conducted according to the OECD TG 404 (NOTOX B.V., 2004).
1-Ethyl-3-methylimidazolium ethylsulfate did not show any adverse effects regarding sensitization, mutagenicity and reproductive toxicity, or after subchronic exposure. As a consequence, a carcinogenic potential is also not anticipated.
WORKER
Point of departure
The starting point is a NOAEL of 1000 mg/kg/day bw obtained in male and female Wistar rats from a subacute (NOTOX B.V., 2005) and from a subchronic oral study (BASF SE, 2011), in which no treatment-related adverse findings were observed up to a dose level of 1000 mg/kg bw/day.
DNEL Calculation - Workers
In general, the derivation of DNEL is based on the above described NOAEL, which is modified as described in R8 (ECHA, May 2008) and ECETOC Guidance on Assessment Factors to Derive DNELs (ECETOC, 2010).
The following factors were also taken into account:
- Based on the ADME observations with the read-across substance (1-butyl-3-methylimidazolium chloride, CAS No. 79917-90-1), the systemic bioavailability of 1-ethyl-3-methylimidazolium ethylsulfate is considered to 62.1 % after oral exposure route and 1-13% (depending on the vehicle used) after dermal exposure (13% will be considered in a worst case approach). The inhalation absorption is assumed to be 100 % (worst case assumption);
- The conversion factors form the oral to inhalation route is 0.38 m³/kg, and exposure adaptation factor of the respiration volume for light activity 6.7 m³/10 m³;
- The intraspecies variation factor is assumed to be 5 (worker);
- Time extrapolation may be omitted as no change concerning the severity of toxicity was observed when comparing the oral acute, subacute and subchronic toxicity studies;
- The ADME observations also suggest that metabolism and accumulation of 1-Ethyl-3-methylimidazolium ethylsulfate is not to be expected. An assessment factor of 1 is therefore regarded as sufficient for remaining interspecies differences.
- Inhalation route – Long-term exposure
For derivation of the worker inhalation DNEL, a route to route extrapolation of the above NOAEL was performed, and different assessment factors were applied.
Long term systemic DNEL derivation (inhalation route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOAEL: 1000 mg/kg bw/day |
OECD Guideline 408; rats, 90 days |
Modification of the starting point |
62.1%/100% = 0.621 |
Absorption |
0.38 m3/kg bw |
Conversion into NOAEC |
|
6.7 m3/10 m3 |
Light activity |
|
Assessment factors |
||
Exposure duration |
1 |
No exposure duration related effects |
Interspecies |
1 |
Include in the conversion |
Intraspecies |
5 |
Workers |
Quality of the data |
1 |
Guideline study (GLP) |
DNEL |
Derivation equation and value |
|
For workers |
([1000 * 62.1/100] * [6.7/10] * [1/0.38]) / (1 x 1 x 5x1) = 218.98 mg/m³ |
|
- Dermal route
The DNELs for dermal long term exposure of workers are also derived from the above mentioned NOAELs.
Long term systemic DNEL derivation (dermal route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOAEL: 1000 mg/kg bw/day |
OECD Guideline 408; rats, 90 days |
Modification of the starting point |
62.1%/13% = 4.78 |
Absorption |
Assessment factors |
||
Exposure duration |
1 |
No exposure duration related effects |
Interspecies |
4 |
Allometric factor |
Remaining differences |
1 |
No metabolism / accumulation |
Intraspecies |
5 |
Workers |
Quality of the data |
1 |
Guideline study (GLP) & reliable read-across |
DNEL |
Derivation equation and value |
|
For workers |
(1000 * [62.1/13]) / (1 x 4 x 1 x 5 x 1)= 238.85 mg/kg bw/day |
|
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 54 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 119.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
GENERAL POPULATION
- Inhalation route
The long-term inhalation DNEL was derived with the same assumptions as for worker, but with general population specific parameters
Long term systemic DNEL derivation (inhalation route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOAEL: 1000 mg/kg bw/day |
OECD Guideline 408; rats, 90 days |
Modification of the starting point |
62.1%/100% = 0.621 |
Absorption |
1.15 m3/kg bw |
Conversion into NOAEC |
|
Assessment factors |
||
Exposure duration |
1 |
No exposure duration related effects |
Interspecies |
1 |
Include in the conversion |
Intraspecies |
10 |
General population |
Quality of the data |
1 |
Guideline study (GLP) |
DNEL |
Derivation equation and value |
|
For general population |
([1000 * 62.1/100] * [1 / 1.15] / (1 x 1 x 10 x 1) = 54 mg/m³ |
|
- Oral route
The same NOAEL as for workers is chosen as the point of departure for the derivation of systemic oral/ DNEL (general population), using general population specific assessment factors
Long term systemic DNEL derivation (oral/dermal route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOAEL: 1000 mg/kg bw/day |
OECD Guideline 408; rats, 90 days |
Modification of the starting point |
Not applicable |
|
Assessment factors |
||
Exposure duration |
1 |
No exposure duration related effects |
Interspecies |
4 |
Allometric factor |
Remaining differences |
1 |
No metabolism / accumulation |
Intraspecies |
10 |
General population |
Quality of the data |
1 |
Guideline study (GLP) & reliable read-across |
DNEL |
Derivation equation and value |
|
For workers |
1000 / (1 x 4 x 1 x 10 x 1)= 25 mg/kg bw/day |
|
- Dermal route
The same NOAEL as for workers is chosen as the point of departure for the derivation of systemic dermal DNEL (general population), using general population specific assessment factors
Long term systemic DNEL derivation (oral/dermal route)
Description |
Values |
Remark |
Relevant dose descriptor |
NOAEL: 1000 mg/kg bw/day |
OECD Guideline 408; rats, 90 days |
Modification of the starting point |
62.1%/13% = 4.78 |
Absorption |
Assessment factors |
||
Exposure duration |
1 |
No exposure duration related effects |
Interspecies |
4 |
Allometric factor |
Remaining differences |
1 |
No metabolism / accumulation |
Intraspecies |
10 |
General population |
Quality of the data |
1 |
Guideline study (GLP) & reliable read-across |
DNEL |
Derivation equation and value |
|
For workers |
(1000 * [62.1/13]) / (1 x 4 x 1 x 10 x 1)= 119.42 mg/kg bw/day |
|
References:
- ECETOC draft, Derivation of Assessment Factors for Human Health Risk Assessment, 2010
- Guidance for the implementation of REACH, Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health. ECHA, Mai 2008.
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