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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:
All data are Klimish 1 or 2. Additional AF for the read-across approach is considered to be not necessary, because it can be reasonably assumed that the NOAEL for the target chemical should be higher than that for the source chemical.
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 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:
All data are Klimish 1 or 2. Additional AF for the read-across approach is considered to be not necessary, because it can be reasonably assumed that the NOAEL for the target chemical should be higher than that for the source chemical.
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 mg/kg bw/day
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