Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
293 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
6
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction factor of 1.763 for dose-response oral -> inhalation (according to R8 ECHA guidance)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
An additional factor for "remaining interspecies differences" as proposed by ECHA is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences [ECETOC. Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010), and Publication No. 901 of the Committee for Hazardous Substances (AGS) of the German Federal Institute for Occupational Safety and Health (BAuA) April 2010].
AF for intraspecies differences:
3
Justification:
ECETOC recommends in its Technical report No. 86 ("Derivation of Assessment Factors for Human Health Risk Assessment"; February 2003); and a default assessment factor for intraspecies differences of 3 for workers deviating from the ECHA proposed assessment factor of 5.
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
Explanation for the modification of the dose descriptor starting point:

According to data of the structural analogue dioctyl ether the oral and dermal LD50 of dihexyl ether is > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure and a DNEL after short-time exposure must not to be derived.

Local 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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 166 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based on the available data a skin penetration of max. 1% is assumed.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
An additional factor for "remaining interspecies differences" as proposed by ECHA is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences [ECETOC. Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010), and Publication No. 901 of the Committee for Hazardous Substances (AGS) of the German Federal Institute for Occupational Safety and Health (BAuA) April 2010].
AF for intraspecies differences:
3
Justification:
ECETOC recommends in its Technical report No. 86 ("Derivation of Assessment Factors for Human Health Risk Assessment"; February 2003); and a default assessment factor for intraspecies differences of 3 for workers deviating from the ECHA proposed assessment factor of 5.
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
Explanation for the modification of the dose descriptor starting point:

According to data of the structural analogue dioctyl ether the dermal LD50 of dihexyl ether is > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure and a DNEL after short-time exposure must not to be derived.

Local 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:
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:
DNEL (Derived No Effect Level)
Value:
87 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
870 mg/m³
Explanation for the modification of the dose descriptor starting point:

Correction factor of 0.87 for dose-response oral -> inhalation (according to R8 ECHA guidance)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
An additional factor for "remaining interspecies differences" as proposed by ECHA is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences [ECETOC. Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010), and Publication No. 901 of the Committee for Hazardous Substances (AGS) of the German Federal Institute for Occupational Safety and Health (BAuA) April 2010].
AF for intraspecies differences:
5
Justification:
ECETOC recommends in its Technical report No. 86 ("Derivation of Assessment Factors for Human Health Risk Assessment"; February 2003); and a default assessment factor for intraspecies differences of 5 for the general population deviating from the ECHA proposed assessment factor of 10.
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

According to data of the structural analogue dioctyl ether the oral and dermal LD50 of dihexyl ether is > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure and a DNEL after short-time exposure must not to be derived.

Local 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 via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
250 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based on the available data a skin penetration of max. 1% is assumed.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
An additional factor for "remaining interspecies differences" as proposed by ECHA is scientifically not justified and arbitrary since the allometric scaling factor fully accounts for interspecies differences [ECETOC. Technical Report in preparation: Guidance on Assessment Factors to Derive DNELs (2010), and Publication No. 901 of the Committee for Hazardous Substances (AGS) of the German Federal Institute for Occupational Safety and Health (BAuA) April 2010].
AF for intraspecies differences:
5
Justification:
ECETOC recommends in its Technical report No. 86 ("Derivation of Assessment Factors for Human Health Risk Assessment"; February 2003); and a default assessment factor for intraspecies differences of 5 for the general population deviating from the ECHA proposed assessment factor of 10.
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

According to data of the structural analogue dioctyl ether the dermal LD50 of dihexyl ether is > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure and a DNEL after short-time exposure must not to be derived.

Local 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:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other:
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Longer exposure duration

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
2
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:
ECETOC recommends in its Technical report No. 86 ("Derivation of Assessment Factors for Human Health Risk Assessment"; February 2003); and a default assessment factor for intraspecies differences of 5 for the general population deviating from the ECHA proposed assessment factor of 10.
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
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