Registration Dossier
Registration Dossier
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EC number: 203-685-6 | CAS number: 109-59-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 72 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: See justification and comments below.
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 433 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting points are potentially the NOAELs of 100ppm (443mg/m3) for developmental toxicity or repeat dose toxicity or 650mg/m3 for reproductive toxicity. On the basis that additional assessment factors are required for duration for repeat dose toxicity when deriving a DNEL, this is used as the starting point. The assessment factors used need to reflect the fact that the most critical effect seen with this substance is haemolysis, which is an effect not seen in humans from exposure to glycol ethers in general.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Route of exposure inhalation so now allometric scaling factor required.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor deemed necessary. See detailed justification in document attached to this record. Rat is likely to be MORE sensitive than humans.
- AF for intraspecies differences:
- 3
- Justification:
- Proposed factor for workers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 180 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: Derivation from a the repeat dose exposure NOAEL. See justification and comments below.
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
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:
- DNEL (Derived No Effect Level)
- Value:
- 10.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Route to route extrapolation from inhalation DNEL.
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
There is no repeat dose dermal study available for isopropoxyethanol. Therefore route to route extrapolation is used to derive a dermal DNEL from the available sub-chronic study by the inhalation route. In both cases, the assumption made is that absorption is 100%. Assuming an inhalation rate of 10m3/8hr and a weight of 70kg, and the starting point the inhalation DNEL of 72m/m3, the DNEL dermal becomes 10.3mg/kg.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Derivation from a the repeat dose exposure NOAEL. See justification and comments below.
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
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:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: See justification and comments below.
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 433 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting points are potentially the NOAELs of 100ppm (443mg/m3) for developmental toxicity or repeat dose toxicity or 650mg/m3 for reproductive toxicity. On the basis that additional assessment factors are required for duration for repeat dose toxicity when deriving a DNEL, this is used as the starting point. The assessment factors used need to reflect the fact that the most critical effect seen with this substance is haemolysis, which is an effect not seen in humans from exposure to glycol ethers in general.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Route of exposure inhalation so now allometric scaling factor required.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor deemed necessary. See detailed justification in document attached to this record.
- AF for intraspecies differences:
- 5
- Justification:
- Proposed factor for consumers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 108 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: Derivation from a the repeat dose exposure NOAEL. See justification and comments below.
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
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:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Route to route extrapolation from inhalation DNEL.
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: Derivation from a the repeat dose exposure NOAEL. See justification and comments below.
- DNEL extrapolated from long term DNEL
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:
- 4.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Derivation from a the repeat dose exposure NOAEL. See justification and comments below.
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 mg/kg bw/day
DNEL related information
- DNEL derivation method:
- other: Derivation from a the repeat dose exposure NOAEL. See justification and comments below.
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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