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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
146.93 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):
6
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881.58 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC(corr.) = NOAEL * (1 / 0.38 m³/kg/d) * (50 / 100) * (6.7 m³ / 10 m³) = 881.58 mg/m³

The NOAEL of 1000 mg/kg bw/day is used as dose descriptor starting point.

AF for dose response relationship:
1
Justification:
default factor
AF for differences in duration of exposure:
2
Justification:
according to ECETOC guidance on assessment
AF for interspecies differences (allometric scaling):
1
Justification:
default factor
AF for intraspecies differences:
3
Justification:
according to ECETOC guidance on assessment
AF for the quality of the whole database:
1
Justification:
default factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
146.93 mg/m³
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:
4 166.67 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):
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:

NOAEL(corr.) = NOAEL * penetration value = 1000 mg/kg bw/day * 100/1 = 100000 mg/kg bw/day

The NOAEL of 1000 mg/kg bw/day is used as dose descriptor starting point.

Penetration value: 1 %

AF for dose response relationship:
1
Justification:
default factor
AF for differences in duration of exposure:
2
Justification:
according to ECETOC guidance on assessment
AF for interspecies differences (allometric scaling):
4
Justification:
default factor
AF for intraspecies differences:
3
Justification:
according to ECETOC guidance on assessment
AF for the quality of the whole database:
1
Justification:
default factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 166.67 mg/cm²
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

Only long term exposure values for worker and general population were calculated, because no concrete values (like NOAEL, LOAEL etc) are available from acute or irritation studies. The study design of the test conducted assessing the acute and local toxicity of dioctylether does not allow in general the derivation of local or acute DNEL, as most of the test were, for example, conducted as limit tests due to animal welfare. In some cases the result of an acute test allows to derive local or acute thresholds. If this is the case the values were entered otherwise this justification is to apply.

For long term effects a valid repeated dose animal study is available to derive DNEL values.The NOAEL was established to be 1000 mg/kg bw and was used as dose descriptor starting point.


General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.478 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):
10
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
434.78 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEC(corr.) = NOAEL * (1 / 1.15 m³/kg/day) * (50 / 100) = 434.78 mg/m³

The NOEL of 1000 mg/kg bw/day is used as dose descriptor starting point.

AF for dose response relationship:
1
Justification:
default factor
AF for differences in duration of exposure:
2
Justification:
according to ECETOC guidance on assessment factors
AF for interspecies differences (allometric scaling):
1
Justification:
default factor
AF for intraspecies differences:
5
Justification:
according to ECETOC guidance on assessment factors
AF for the quality of the whole database:
1
Justification:
default factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
43.478 mg/m³
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:
2 500 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):
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:

NOAEL(corr.) = NOAEL * penetration value = 1000 mg/kg bw/day * 100/1 = 100000 mg/kg bw/day

The NOAEL of 1000 mg/kg bw/day is used as dose descriptor starting point.

Penetration value: 1 %

AF for dose response relationship:
1
Justification:
default factor
AF for differences in duration of exposure:
2
Justification:
according to ECETOC guidance on assessment factors
AF for interspecies differences (allometric scaling):
4
Justification:
default factor
AF for intraspecies differences:
5
Justification:
according to ECETOC guidance on assessment factors
AF for the quality of the whole database:
1
Justification:
default factor
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:
25 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):
40
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:

NOAEL(corr.) = NOAEL = 1000 mg/kg bw/day

The NOAEL of 1000 mg/kg bw/day is used as dose descriptor starting point.

AF for dose response relationship:
1
Justification:
default factor
AF for differences in duration of exposure:
2
Justification:
according to ECETOC guidance on assessment factors
AF for interspecies differences (allometric scaling):
4
Justification:
default factor
AF for intraspecies differences:
5
Justification:
according to ECETOC guidance on assessment factors
AF for the quality of the whole database:
1
Justification:
default factor
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

Only long term exposure values for worker and general population were calculated, because no concrete values (like NOAEL, LOAEL etc) are available from acute or irritation studies. The study design of the test conducted assessing the acute and local toxicity of dioctylether does not allow in general the derivation of local or acute DNEL, as most of the test were, for example, conducted as limit tests due to animal welfare. In some cases the result of an acute test allows to derive local or acute thresholds. If this is the case the values were entered otherwise this justification is to apply.

For long term effects a valid repeated dose animal study is available to derive DNEL values.The NOAEL was established to be 1000 mg/kg bw and was used as dose descriptor starting point.