Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.3 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):
75
Dose descriptor starting point:
NOAEL
DNEL value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
926 mg/m³
Explanation for the modification of the dose descriptor starting point:

The default calculator has been applied: Starting point is NOAEL of 750 mg/kg bw/day from Combined repeated dose/reproduction screening in rat, where animals are dosed for 29-32 days (males) and average 54 days (females, range 50-67 days.

The corrected 8 hr inhalation NOAEC for workers is calculated applying the default calculation: oral NOAELrat * 1/0.38 * 6.7/10. Additionally, a correction for differences between human and experimental exposure conditions of 1.4 is added (5 d/w versus experimental daily exposure). With the additional extrapolation factor of 2 from oral to inhalation route of exposure, this results to a NOAEC workers of 926 mg/m3.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.5 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):
300
Dose descriptor starting point:
NOAEL
DNEL value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 050 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The default calculator has been applied: Starting point is NOAEL of 750 mg/kg bw/day from Combined repeated dose/reproduction screening in rat, where animals are dosed for 29-32 days (males) and average 54 days (females, range 50-67 days. At this stage no data are available on dermal absorption and 100% dermal absorption is considered as worst-case assumption. Additionally a correction for differences between human and experimental exposure conditions of 1.4 is added (5 d/w versus experimental daily exposure): 8hr-NOAEL workers = NOAEL(750 mg/kg) * 1.4 = 1050 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

C12-14 Alkyl ethoxylated glycidylether only has industrial application as intermediate in chemical production in which the substance is completely consumed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard 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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard 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

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

C12-14 Alkyl ethoxylated glycidylether only has application as intermediate in chemical production in which is is completely consumed, and is not used in the consumer sector. Furthermore, DNELs for general public are not required as tonnage is below 1000 tpa, and substance is not classified as CMR or STOT-RE Cat.1