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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.88 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL was calculated according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015) based in the NOAEC of the key repeated dose study (inhalation).
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
187 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
94 mg/m³
Explanation for the modification of the dose descriptor starting point:

Calculation from NOAEC (inhalation,rat) to NOAEC corrected (inhalation, human):


NOAEC corr. = NOAEC (inhal) * (6/8) h/d * (6.7/10) m³

AF for differences in duration of exposure:
4
Justification:
AF according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for other interspecies differences:
2.5
Justification:
AF according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for intraspecies differences:
5
Justification:
AF according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.27 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL was calculated according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015) based in the NOAEC of the key repeated dose study (inhalation).
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
Value:
187 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
53.4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL corrected = NOAEC * 6/8 h * 0,384 m³/kg bw/d = 53.4 mg/kg bw/m³


with correction for exposure regime = 6/8 h/d and standard respiratory volume = 0.384 m³/kg bw/d

AF for differences in duration of exposure:
4
Justification:
AF according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015).
AF for interspecies differences (allometric scaling):
4
Justification:
AF according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015).
AF for other interspecies differences:
2.5
Justification:
AF according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015).
AF for intraspecies differences:
5
Justification:
AF according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015).
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
DNEL (Derived No Effect Level)
Value:
0.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL was calculated according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015) based in the NOAEC of the key repeated dose study (inhalation).
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
187 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
33.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC corrected = NOAEC * 6/24 h * 5/7 d = 33.4 mg/m³


with 6/24 h/d * 5/7 d being the correction for exposure regime

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for other interspecies differences:
2.5
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for intraspecies differences:
10
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.09 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL was calculated according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015) based in the NOAEC of the key repeated dose study (inhalation).
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEC
Value:
187 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
38.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL corrected = NOAEC * 6/8 h * 5/7 d *  0,384 m³/kg bw/d = 38.5 mg/kg bw/d


with correction for exposure regime = 6/8 h/d * 5/7 d and standard respiratory volume = 0.384 m³/kg bw/d

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for interspecies differences (allometric scaling):
4
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for other interspecies differences:
2.5
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for intraspecies differences:
10
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL was calculated according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015) based in the NOAEC of the key repeated dose study (inhalation).
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEC
Value:
187 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
38.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL corrected = NOAEC * 6/8 h * 5/7 d* 0.384 m³/kg bw/d = 38.5 mg/kg bw/d


with correction for exposure regime = 6/8 h/d * 5/7 d and standard respiratory volume = 0.384 m³/kg bw/d

AF for differences in duration of exposure:
4
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for interspecies differences (allometric scaling):
4
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for other interspecies differences:
2.5
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for intraspecies differences:
10
Justification:
AF for subacute to chronic exposure according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
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