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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.68 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL was taken from "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:
167 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
83.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC (corrected) adjusted  according to ECHA guidedance:


NOAEC (corrected) = NOAEC * 6/8 h/d * 6.7/10 m³

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 remaining interspecies differences according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences 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:
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:
0.24 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 taken from "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:
167 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
48.1 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 = 48.1 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 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 interspecies differences according to ECHA Guideline
AF for other interspecies differences:
2.5
Justification:
AF for other interspecies differences according to "Application for Authorisation: DNEL setting for reprotoxic properties of Diglyme" by RAC (05 June 2015)
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences 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:
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:
DNEL (Derived No Effect Level)
Value:
0.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL was taken from "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:
167 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
29.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC corr = NOAEC * 6/24 h/d * 5/7 d


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 other interspecies differences 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 intraspecies differences 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:
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:
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 taken from "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:
167 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
34.4 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 = 34,4 mg/kg bw/m³


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 interspecies differences 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 other interspecies differences 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 intraspecies differences 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:
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:
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 taken from "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:
167 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
34.4 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 = 34.4 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 interspecies differences 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 other interspecies differences 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 intraspecies differences 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