Registration Dossier
Registration Dossier
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EC number: 203-560-6 | CAS number: 108-20-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 850 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 700 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 2
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 121.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Worker:
Production of diisopropyl ether (DIPE) is in excess of 10 t/y. According to the REACh "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs, derived from Maximale Arbeitsplatzkonzentration (MAK) values, are available for DIPE, and this substance is not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived.
Long-term DNELs:
The DNEL was derived from the German TLV (MAK value), which was based on a subchronic (90-day) inhalation study on rats (Dalbey and Feuston, 1996) reporting a NOEL of 480 ppm. This also took into account an irritative effect (category 1) and a permissible overstepping factor of 2. There were no irritative effects observed in humans at the maximum permissible exposure to 400 mL/m3 (400 ppm). Based on an evaluation of the reproductive arm of the Dalbey and Feuston (1996) study, DIPE was considered not to have any reproductive toxic effects. [Excerpt from the MAK Collection, 30th edition, 2000].
Reference: Deutsche Forschungsgemeinschaft List of MAT and BAT values 2007. Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area Report.
Starting Dose for DNEL calculation:
850 mg/m3 (based on Occupational Exposure of 8 hours/day, 5 days/week)
Modified dose for DNEL Calculation:
Worker - Inhalation: 850mg/m3 (no adjustment required)
Worker - Dermal = 850 mg/m3x 10 m3/d/70 kg = 121.4 mg/kg
Assessment factors:
No adjustments required for interspecies, exposure duration, dose response or quality of whole database as DNEL is based on an occupational limit for workers.
Absorption data:
The low molecular weight (102.17 g/mol), log POW, physical state, moderate vapour pressure (19.9 kPa at 25°C), and high water solubility of di-isopropyl ether (DIPE) favour its absorption via various routes of exposure (i.e., oral, dermal, and respiratory). In the absence of quantitative data, it was assumed that absorption by all dose routes was 100%.
Final DNELs:
Worker - Inhalation: 850 mg/m3
Worker - Dermal: 121.4 mg/kg
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 151 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 2
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 302 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 4
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Acute DNELs:
General population: similar to above for worker, assessment of acute systemic effects should default to the long term systemic DNELS; DIPE not classified as a skin irritant; default to systemic DNEL for effects.
Long-term DNELs:
The long-term DNEL for the general population was derived from the worker occupational exposure limit.
Starting dose for DNEL calculation:
850 mg/m3 based on occupational exposure of 8 hours/day, 5 days/week. Amortized below for continuous exposure.
Modified dose for DNEL calculation:
General population inhalation: (amortized for continuous exposure) = 850 mg/m3x 10/6.7 x 8/24 x 5/7 = 302 mg/m3
General population oral: 302 mg/m3x 20 m3/ 70 kg = 86.28 mg/kg/d (no adjustment for absorption, because assumed to be 100%)
General population dermal: 302 mg/m3x 20 m3/ 70= 86.28 mg/kg/day (Assumed absorption of 100% in the absence of quantifiable data)
Assessment factors:
No adjustments required for interspecies, exposure duration, dose response or quality of whole database as DNEL is based on an occupational limit for workers.
REACh guidance recommends an AF of 10 for the general population and 5 for the workers. As the DNELs are based on an occupational exposure limit, an AF of 2 is applied to account for the differences between general population and the workers (10/5 = 2).
Final DNELs:
General population Dermal: 86.28 mg/kg bw/d / 2 = 43.1 mg/kg bw/day
General population Inhalation: 302 mg/m3/2 = 151 mg/m3
General population Oral: 86.28 mg/kg bw/day/2 =43.1 mg/kg bw/day
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