Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
47 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: most closely equivalent to ECHA REACH Guidance
Overall assessment factor (AF):
18.75
Modified dose descriptor starting point:
NOAEC
Value:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:
ECHA REACH Guidance default procedure: correction factor = (1 / standard respiratory volume rat) x (absorption oral rat / absorption inhal. human) x (standard respiratory volume human / worker respiratory volume) ### correction factor = (1 / 0.38 m^3 /kg) x (1 / 2) x (6.7 m^3 per person (8h) / 10 m^3 per person (8h)) ### correction factor = 0.882 ### 0.882 x 1000 mg/kg bw = 882 mg/kg bw = corrected starting point
AF for dose response relationship:
0.5
Justification:
The default AF of 1 for NOAEL was modiefied because of the absence of any adverse effects at the highest dose level tested indicating that the real NOEAL is still higher.
AF for differences in duration of exposure:
3
Justification:
The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications for upcoming accumulation.
Justification:
Already implemented in the calculation of the correct starting point
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance default AF
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance default AF for worker
AF for the quality of the whole database:
1
Justification:
Good quality
Justification:
not applied
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:
13.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: most closely equivalent to ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
worst case assumption: dermal absorption does not deceed oral absorption
AF for dose response relationship:
0.5
Justification:
The default AF of 1 for NOAEL was modiefied because of the absence of any adverse effects at the highest dose level tested indicating that the real NOEAL is still higher.
AF for differences in duration of exposure:
3
Justification:
The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications for upcoming accumulation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance default AF for rat-human
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance default AF
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance default AF for worker
AF for the quality of the whole database:
1
Justification:
Good quality
Justification:
not applied
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:
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:
555 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: most closely equivalent to ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Modified dose descriptor starting point:
NOAEC
Value:
20 833 mg/m³
Explanation for the modification of the dose descriptor starting point:
ECHA REACH Guidance default procedure: correction factor = (1 / standard respiratory volume rat) x (absorption oral rat / absorption inhal. human) ### correction factor = (1 / 0.024 m^3 /kg) x (1 / 2) ### correction factor = 20.833 ### 20.833 x 1000 mg/kg bw = 20833 mg/kg bw = corrected starting point ### Note: The 8h standard respiratory volume of the rat rat was adjusted to 0.5 h, because inhalation exposure during use of DOBA containing products is very short and 0.5 h can be taken as worst case assumption.
AF for dose response relationship:
0.5
Justification:
The default AF of 1 for NOAEL was modiefied because of the absence of any adverse effects at the highest dose level tested indicating that the real NOEAL is still higher.
AF for differences in duration of exposure:
3
Justification:
The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications for upcoming accumulation.
Justification:
Already implemented in the calculation of the correct starting point
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance default AF
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance default AF for general population
AF for the quality of the whole database:
1
Justification:
Good quality
Justification:
not applied
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:
6.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: most closely equivalent to ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
worst case assumption: dermal absorption does not deceed oral absorption
AF for dose response relationship:
0.5
Justification:
The default AF of 1 for NOAEL was modiefied because of the absence of any adverse effects at the highest dose level tested indicating that the real NOEAL is still higher.
AF for differences in duration of exposure:
3
Justification:
The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications for upcoming accumulation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance default AF for rat-human
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance default AF
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance default AF for general population
AF for the quality of the whole database:
1
Justification:
Good quality
Justification:
not applied
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:
6.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: most closely equivalent to ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
0.5
Justification:
The default AF of 1 for NOAEL was modiefied because of the absence of any adverse effects at the highest dose level tested indicating that the real NOEAL is still higher.
AF for differences in duration of exposure:
3
Justification:
The default AF of 6 (for subacute to chronic) was modified because of the absence of any indications for upcoming accumulation.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance default AF for rat-human
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance default AF
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance default AF for general population
AF for the quality of the whole database:
1
Justification:
Good quality
Justification:
not applied
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