Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.94 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):
112.5
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
106 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation was performed in accordance with the ECHA guidance document from the oral study to the inhalation route using the assumption that inhalation bioavailability was 50% and oral biioavailability was 100% (refer to TK section for justification for these bioavailabilities).

AF for dose response relationship:
1
Justification:
ECHA default; a clear dose response was observed for the key findings.
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for Butyl Phenyl ether indicates it is metabolised well and does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
route to route extrapolation addresses Allometric scaling
AF for other interspecies differences:
2.5
Justification:
ECHA default factor used
AF for intraspecies differences:
5
Justification:
ECHA default factor used
AF for the quality of the whole database:
1
Justification:
reliable well performed studies form the basis of the DNEL derivation
AF for remaining uncertainties:
3
Justification:
Factor of 3 used to convert LOAEL to NOAEL
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:
0.2 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):
450
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
90 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation from oral to dermal route performed in accordance with the ECHA guidance document. As indicated in the toxicokinetic section, oral and dermal bioavailability are considered to be similar (approx 100%), however an additional factor of 3 has been applied to the starting point to account for the differences in kinetics - specifically, due to differences in dermal absorption rate versus oral absorption rate it is predicted that approximately 3 times higher dermal dose would be needed to get the same Cmax as an oral dose.

AF for dose response relationship:
1
Justification:
ECHA default; a clear dose response was observed for the key findings.
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for Butyl Phenyl ether indicates it is metabolised well and does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default factor used
AF for other interspecies differences:
2.5
Justification:
ECHA default factor used
AF for intraspecies differences:
5
Justification:
ECHA default factor used
AF for the quality of the whole database:
1
Justification:
ECHA default factor used
AF for remaining uncertainties:
3
Justification:
Factor of 3 used to convert LOAEL to NOAEL
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.23 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):
225
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
52.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation was performed in accordance with the ECHA guidance document from the oral study to the inhalation route using the assumption that inhalation bioavailability was 50% and oral biioavailability was 100% (refer to TK section for justification for these bioavailabilities).

AF for dose response relationship:
1
Justification:
ECHA default; a clear dose response was observed for the key findings.
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for Butyl Phenyl ether indicates it is metabolised well and does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric differences accounted for in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
ECHA Default
AF for remaining uncertainties:
3
Justification:
Factor of 3 used to convert LOAEL to NOAEL
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:
0.1 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):
900
Dose descriptor starting point:
LOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
90 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation from oral to dermal route performed in accordance with the ECHA guidance document. As indicated in the toxicokinetic section, oral and dermal bioavailability are considered to be similar (approx 100%), however an additional factor of 3 has been applied to the starting point to account for the differences in kinetics - specifically, due to differences in dermal absorption rate versus oral absorption rate it is predicted that approximately 3 times higher dermal dose would be needed to get the same Cmax as an oral dose.

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
3
Justification:
Extrapolation from a mid-term study period to a chronic study period. In the 2011 publication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to a longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for Butyl Phenyl ether indicates it is metabolised well and does not have the potential to bioaccumulate. Consequently a lower factor of 3 is considered appropriate for the duration extrapolation.
AF for interspecies differences (allometric scaling):
4
Justification:
Echa Default
AF for other interspecies differences:
2.5
Justification:
ECHA Default
AF for intraspecies differences:
10
Justification:
ECHA Default
AF for the quality of the whole database:
1
Justification:
ECHA Default
AF for remaining uncertainties:
3
Justification:
Factor of 3 used to convert LOAEL to NOAEL
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:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population