Bromine

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.7 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

Route of original study:

By inhalation

DNEL related information

DNEL derivation method:

other: scientific justification lead effect: local irritation copared to DNEL of bromide

Overall assessment factor (AF):

2

Modified dose descriptor starting point:

other: irritation ththreshold in humans

Value:

0.7 mg/m³

Explanation for the modification of the dose descriptor starting point:

not applicable

AF for dose response relationship:

1

Justification:

see below

AF for differences in duration of exposure:

1

Justification:

see below data and weight of evidence analysis show that irritation threshold is concentration rather than duration related.

AF for interspecies differences (allometric scaling):

1

Justification:

Based on human data

AF for other interspecies differences:

1

Justification:

Based on human data

AF for intraspecies differences:

2

Justification:

Data from adult volunteers and accidental general population exposure are comparable

AF for the quality of the whole database:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

AF for remaining uncertainties:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.7 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

Route of original study:

By inhalation

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

2

Modified dose descriptor starting point:

other: irritation threshold humans

Value:

1.43 mg/m³

Explanation for the modification of the dose descriptor starting point:

not applicable

AF for dose response relationship:

1

Justification:

see below

AF for interspecies differences (allometric scaling):

1

Justification:

Based on human data

AF for other interspecies differences:

1

Justification:

Based on human data

AF for intraspecies differences:

2

Justification:

Data from adult volunteers and accidental general population exposure are comparable

AF for the quality of the whole database:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

AF for remaining uncertainties:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.7 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

2

Dose descriptor:

other: irritation threshold in humans

AF for dose response relationship:

1

Justification:

see below

AF for differences in duration of exposure:

1

Justification:

see below data and weight of evidence analysis show that irritation threshold is concentration rather than duration related.

AF for interspecies differences (allometric scaling):

1

Justification:

Based on human data

AF for other interspecies differences:

1

Justification:

Based on human data

AF for intraspecies differences:

2

Justification:

Data from adult volunteers and accidental general population exposure are comparable

AF for the quality of the whole database:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

AF for remaining uncertainties:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.7 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

2

Dose descriptor starting point:

other: human irritation threshold

AF for dose response relationship:

1

Justification:

see below

AF for interspecies differences (allometric scaling):

1

Justification:

Based on human data

AF for other interspecies differences:

1

Justification:

Based on human data

AF for intraspecies differences:

2

Justification:

Data from adult volunteers and accidental general population exposure are comparable

AF for the quality of the whole database:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

AF for remaining uncertainties:

1

Justification:

Based on weight of evidence approach with supporting information and on SCOEL recommendation

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

low hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

Acute/short term exposure

Hazard assessment conclusion:

no DNEL required: short term exposure controlled by conditions for long-term

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

high hazard (no threshold derived)

Additional information - workers

Bromine is very toxic and corrosive at relatively low airborne concentrations. The available human data indicate that acute exposure to bromine gas results in serious adverse effects which in some cases may be delayed for a period after exposure. These effects are triggered by the severe local reactions in the repiratory tract. The effects are concentration rather than dose dependent. In consequence an acute DNEL for bromine exposure is derived based on the IOELV for 8-hour inhalation exposure that should not be exceeded also for short periods to prevent local reactions in the respiratory tract. The same value should apply to repeated inhalation exposure so as not to exceed an irritation level in the workplace that is triggered more by the concentration than the duration of exposure. . Bromine levels should not breach the IOELV for 8-hour inhalation exposure (0.7 mg/m³).

Dermal DNELs were not derived as the dermal effects are driven by the severe corrosivity of bromine. Risk management measures need to be applied that prevent skin contact to avoid any skin irritation or corrosivity. DNELs for systemic toxicity via the inhalation and dermal route as well as for toxicity to reproduction and development were not derived, as it can reasonably be assumed that due to thecorrosive properties and primary toxic (irritative) effects on the site of first contact it is not possible to reach systemic levels that would cause toxicity.

Due to the reactivity of bromine with moisture with the hydrolysis reaction ultimately yielding bromide ions, any systemic repeated dose or reproductive effects would be due to bromide. Bromide levels from bromine exposure are unlikely to reach levels higher than normal background levels (sources include food and water) due to the primary toxic and irritative effects of bromine at the site of first contact.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

high hazard (no threshold derived)

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

high hazard (no threshold derived)

Additional information - General Population

Bromine is very toxic and corrosive at relatively low airborne concentrations. The available human data indicates that acute exposure to bromine gas results in serious adverse effects which in some cases may be delayed for a period after exposure. Bromine is only used as intermediate for chemical or polymer production in industry . When used it will immediately react and will not be present in any final products outside the industrial setting. Therefore consumer exposure will not occur. The general population will not be exposed to the substance during its lifecycle.

For further discussion of the DNEL derivation see attachement.