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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
other:
Value:
75 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation studies available. Substance classified as corrosive.
AF for differences in duration of exposure:
6
Justification:
ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance
AF for other interspecies differences:
2.5
Justification:
ECHA guidance
AF for intraspecies differences:
5
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
132 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
other: NOAEL
Value:
75 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation studies available.Substance classified as corrosive.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance
AF for other interspecies differences:
2.5
Justification:
ECHA guidance
AF for intraspecies differences:
5
Justification:
ECHA guidance

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

For hazard via inhalation route the systemic effect hazard assessment conclusion is based on DNEL derived from a 7-day oral dose range-finding study in rats (BIOTOX-21), which is the only available repeated dose study. This study is used for both long term and acute/short term exposures. Because FPBO is skin corrosive (subcategory 1C), further testing for systemic effects is not justified. For local effects via inhalation and dermal routes the hazard assessment conclusion is skin irritation / corrosion as it is considered the most relevant endpoint.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
other:
Value:
75 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation studies available.Substance classified as corrosive.
AF for differences in duration of exposure:
6
Justification:
ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance
AF for other interspecies differences:
2.5
Justification:
ECHA guidance
AF for intraspecies differences:
10
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
other: NOAEL
Value:
75 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation studies available.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance
AF for other interspecies differences:
2.5
Justification:
ECHA guidance
AF for intraspecies differences:
10
Justification:
ECHA guidance

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
AF for differences in duration of exposure:
6
Justification:
ECHA guidance
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance
AF for other interspecies differences:
2.5
Justification:
ECHA guidance
AF for intraspecies differences:
10
Justification:
ECHA guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.5 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance
AF for other interspecies differences:
2.5
Justification:
ECHA guidance
AF for intraspecies differences:
10
Justification:
ECHA guidance

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

For hazard via inhalation route the systemic effect hazard assessment conclusion is based on DNEL derived from a 7-day oral dose range-finding study in rats (BIOTOX-21), which is the only available repeated dose study. This study is used for both long term and acute/short term exposures. Because FPBO is skin corrosive (subcategory 1C), further testing for systemic effects is not justified. For local effects via inhalation and dermal routes the hazard assessment conclusion is skin irritation / corrosion as it is considered the most relevant endpoint.