Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.04 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):
25
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
26.45 mg/m³
Explanation for the modification of the dose descriptor starting point:

The oral NOAEL rat (mg/kgbw/day) is convert into inhalatory NOAEL rat (mg/m3) by using a default respiratory volume for the rat corresponding to the daily duration of human exposure (sRVrat = 0.38 m3/ kgbw for 8 hours).

In this approach, it is considered that absorptions between oral route for rat and inhalatory route for human are the same (ABS oral-rat = ABS inh-human).

And to finalise the conversion for workers, an addition correction is used for the difference between respiratory rates under standard conditions and under conditions of light activity (sRV human = 6.7 m3 and wRV = 10 m3 ).

The modified dose is :

corrected inhalatory NOAEC = oral NOAEL x 1/sRVrat x ABS oral-rat/ ABS inh-human x sRVhuman/wRV = oral NOAEL x 1.76

corrected inhalatory NOAEC = 26.45 mg/m3

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
ECHA assessment factors for sub-chronic to chronic (table R 8-5, chapter R8)
AF for interspecies differences (allometric scaling):
1
Justification:
As indicated in the ECHA guidance (Table 8-4, chapter R8), an allometric scaling is not to apply if an oral dose is used to elaborate a inhalation dose.
AF for other interspecies differences:
1
AF for intraspecies differences:
5
Justification:
ECHA assessment factors for Intraspecies / workers (table R 8-6, chapter R8)
AF for the quality of the whole database:
1
Justification:
The NOAEL is based on an analogue (Diphenyl Ether) with only one toxicokinetics study that is justified an AF for the quality of the whole database. But, as indicated in "justification on classification or non classification" for repeated dose toxicity, this NOAEL is very low compared to another NOAEL for Diphenyl Ether (NOAEL indicated in the REAC dossier). Therefore, no AF for the quality of the whole database is retained.
AF for remaining uncertainties:
2.5
Justification:
ECHA assessment factors for Interspecies (remaining differences) (table R 8-6, chapter R8).
Due a read-across approach, this factor is applied.
Since the NOAEL use for deriving the DNEL is very low, no additional factor was applied even if the data used came from an analogue.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

Workers - 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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

General population is not exposed to 4-Phenoxyphenol. Since this substance is only used in industrial sites, there is no direct consumer exposure to 4-Phenoxyphenol. Furthermore, the indirect exposure of humans via environment is not relevant since the substance is readily biodegradable and since there is no indication of a bioaccumulation potential.