Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
700 mg/m³
Explanation for the modification of the dose descriptor starting point:
Assuming: human body weight of 70 kg; respiration volume of 10m3 for a shift; comparable resorption for oral and inhalation routes
AF for dose response relationship:
1
Justification:
Clear dose responce relation obtained
AF for differences in duration of exposure:
1
Justification:
Steady state within 9 day and efficient elimination demonstrated for the toxicant 2-butoxyactic acid in rats treated up to 28-days; no bioaccumulating effect observed in the subchronic and chronic studies with EGBE.
AF for interspecies differences (allometric scaling):
4
Justification:
Extrapolation from rat to human
AF for other interspecies differences:
1
Justification:
Hemolytic acitivity of 2-butoxyacetic acid as mode of action demonstrated; human less susceptible to the given mode of action demonstrated.
AF for intraspecies differences:
2.5
Justification:
AF of 2.5 is considered to be appropriate as the susceptible population is identified; females are more susceptible to males. Use of 2.5 for intraspecies is also mentioned in TRGS 900 for EGBE that shares the 2-butoxyacetic acid as toxic metabolites with DEGDBE.
AF for the quality of the whole database:
1
Justification:
Most of the studies used to assess the health hazard are scientifically well performed, Guideline studies and GLP studies; the applied read-across is based on the same toxicity mode of action and is considered to be very robust; no additional AF needed
AF for remaining uncertainties:
1
Justification:
Any additional uncertainties not known
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
DNEL value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Comparable resorption for oral and dermal routes is assumed
AF for dose response relationship:
1
Justification:
Clear dose responce relation obtained
AF for differences in duration of exposure:
1
Justification:
Steady state within 9 day and efficient elimination demonstrated for the toxicant 2-butoxyactic acid
AF for interspecies differences (allometric scaling):
4
Justification:
Extrapolation factor from rat to human
AF for other interspecies differences:
1
Justification:
Hemolytic acitivity of 2-butoxyacetic acid as mode of action demonstrated; human less susceptible to the given mode of action demonstrated.
AF for intraspecies differences:
2.5
Justification:
AF of 2.5 is considered to be appropriate as the susceptible population is identified; females are more susceptible to males. Use of 2.5 for intraspecies is also mentioned in TRGS 900 for EGBE that shares the 2-butoxyacetic acid as toxic metabolites with DEGDBE.
AF for the quality of the whole database:
1
Justification:
Most of the studies used to assess the health hazard are scientifically well performed, Guideline studies and GLP studies; the applied read-across is based on the same toxicity mode of action and is considered to be very robust; no additional AF needed
AF for remaining uncertainties:
1
Justification:
Any additional uncertainties not known
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population