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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.5 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
525 mg/m³
Explanation for the modification of the dose descriptor starting point:
Comparable resorption for oral and inhalation routes; Human body weight of 70 kg/person; Daily respiration volume for a worker of 10 mg/m3
AF for dose response relationship:
1
Justification:
A clear dose response relation established in the original study.
AF for differences in duration of exposure:
1
Justification:
The endpoint developmental toxicity is used as bases for DNEL. AF of 1 is normally used for this endpoint (i.e. In accordance with DENL derivation for 2-Methoxyethanol in Annex XV dossier).
AF for interspecies differences (allometric scaling):
2.4
Justification:
The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
The provided studies are considered fully reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified.
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:
2.5 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Comparable resorption for oral and dermal routes.
AF for dose response relationship:
1
Justification:
A clear dose response relation established in the original study.
AF for differences in duration of exposure:
1
Justification:
The endpoint developmental toxicity is used as bases for DNEL. AF of 1 is normally used for this endpoint (i.e. In accordance with DNEL derivation for 2-Methoxyethanol in Annex XV dossier).
AF for interspecies differences (allometric scaling):
2.4
Justification:
The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
The available data are considered as fully reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified.
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:
other toxicological threshold
Value:
0.5 µg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
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:
other toxicological threshold
Value:
1 µg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
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:
1.25 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
75
Explanation for the modification of the dose descriptor starting point:

No modification needed. 

AF for dose response relationship:
1
Justification:
A clear dose response relation established in the original study.
AF for differences in duration of exposure:
1
Justification:
The endpoint developmental toxicity is used as bases for DNEL. AF of 1 is normally used for this endpoint (i.e. In accordance with DNEL derivation for 2-Methoxyethanol in Annex XV dossier).
AF for interspecies differences (allometric scaling):
2.4
Justification:
The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
The provided studies are considered fully reliable.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified.
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