Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.88 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):
75
Modified dose descriptor starting point:
NOAEC
Value:
440.789 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAEC (inhal) = 250*1/0.38 m3/kg/d*100/100*6.7m3/10m3
AF for dose response relationship:
1
Justification:
Default factor Table R8-6
AF for differences in duration of exposure:
6
Justification:
Subacute to Chronic (Table R8-6)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is accounted for in the NOAEC extrapolation
AF for other interspecies differences:
2.5
Justification:
Default factor Table R8-6
AF for intraspecies differences:
5
Justification:
Worker Table R8-6
AF for the quality of the whole database:
1
Justification:
Default factor Table R8-6
AF for remaining uncertainties:
1
Justification:
Default factor Table R8-6
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:
0.833 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Human dermal adsorption is considered to be lower than the oral adsortion rate of rats. Hence direct equivalence between oral and dermal toxicity is assumed.
AF for dose response relationship:
1
Justification:
Default factor Table R8-6
AF for differences in duration of exposure:
6
Justification:
Subacute to Chronic (Table R8-6)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human Table R8-3
AF for other interspecies differences:
2.5
Justification:
Default factor Table R8-6
AF for intraspecies differences:
5
Justification:
Worker Table R8-6
AF for the quality of the whole database:
1
Justification:
Default factor Table R8-6
AF for remaining uncertainties:
1
Justification:
Default factor Table R8-6
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:
0.827 mg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
other: Extrapolation from negative response.
Overall assessment factor (AF):
37.5
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
1
Justification:
not applicable for sensitisation
AF for interspecies differences (allometric scaling):
3
Justification:
guinea pigs to humans based on Table R8-3
AF for intraspecies differences:
5
Justification:
workers based on Table R8-6
AF for the quality of the whole database:
1
Justification:
based on Table R8-6
AF for remaining uncertainties:
2.5
Justification:
based on Table R8-6
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The only long-term study conducted on PX-200 is a 28 -day repeat dose oral toxicity study. No long-term studies were conducted using either the dermal or inhalation routes of exposure. The substance is classified as a sensitiser, although the data desmonstrate that the response is close to the threshold of concern. The substance is only ever handled in industry and will generally be under closed conditions.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.45 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
217.39 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAEC (inhal) = 250*1/1.15*100/100
AF for dose response relationship:
1
Justification:
Default factor Table R8-6
AF for differences in duration of exposure:
6
Justification:
Subacute to Chronic (Table R8-6)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is accounted for in the NOAEC extrapolation
AF for other interspecies differences:
2.5
Justification:
Default factor Table R8-6
AF for intraspecies differences:
10
Justification:
General population Table R8-6
AF for the quality of the whole database:
1
Justification:
Default factor Table R8-6
AF for remaining uncertainties:
1
Justification:
Default factor Table R8-6
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:
0.417 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Human dermal adsorption is considered to be lower than the oral adsortion rate of rats. Hence direct equivalence between oral and dermal toxicity is assumed.
AF for dose response relationship:
1
Justification:
Default factor Table R8-6
AF for differences in duration of exposure:
6
Justification:
Subacute to Chronic (Table R8-6)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human Table R8-3
AF for other interspecies differences:
2.5
Justification:
Default factor Table R8-6
AF for intraspecies differences:
10
Justification:
General population Table R8-6
AF for the quality of the whole database:
1
Justification:
Default factor Table R8-6
AF for remaining uncertainties:
1
Justification:
Default factor Table R8-6
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:
0.413 mg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
other: Extrapolation from negative response.
Overall assessment factor (AF):
75
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
1
Justification:
not applicable for sensitisation
AF for interspecies differences (allometric scaling):
3
Justification:
guinea pigs to humans based on Table R8-3
AF for intraspecies differences:
10
Justification:
general population based on Table R8-6
AF for the quality of the whole database:
1
Justification:
based on Table R8-6
AF for remaining uncertainties:
2.5
Justification:
based on Table R8-6
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.417 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default factor Table R8-6
AF for differences in duration of exposure:
6
Justification:
Subacute to Chronic (Table R8-6)
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human Table R8-3
AF for other interspecies differences:
2.5
Justification:
Default factor Table R8-6
AF for intraspecies differences:
10
Justification:
General population Table R8-6
AF for the quality of the whole database:
1
Justification:
Default factor Table R8-6
AF for remaining uncertainties:
1
Justification:
Default factor Table R8-6
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

The general public will never be exposed to the submission substance. The final end-use of the submission substance is as a flame retardent ingredient of pre-pregnated sheets used in the manufacture of electronic circuit baords. These electronic circuit boards are subsequently used as components of electronic goods used by the general public, such as televisions and refrigerators. During normal use, no exposure is expected. These electronic goods should then be recycled according to national legislation.

Wherever possible, DNELs are included in this section purely for completeness even though exposure to the general population can be excluded.