Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEC
Value:
250 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
126 mg/m³
Explanation for the modification of the dose descriptor starting point:

A systemic NOEAC of 250 mg/m3 has been identified from a 28 day inhalation study in rats exposed to the read-across substance benzoic acid.

Corrected NOEAC = 250 mg/m3 x 6h/8h x 6.7 m3/ 10m3 = 126 mg/m3

DNEL = 126 mg/m3 / (2.5 interspecies factor x 5 intraspecies factor x 6 duration factor) = 1.7 mg/m3

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
subacute study
AF for interspecies differences (allometric scaling):
1
Justification:
inhalation, default
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default
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:
0.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
225
Dose descriptor:
LOAEC
Value:
25 mg/m³
AF for dose response relationship:
225
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
1
Justification:
inhalation default
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
3
Justification:
LOAEC to NOAEC extrapolation
Justification:
A LOAEC of 25 mg/m3 based on local effects in the lung has been identified from a 28 day inhalation study in rats exposed to the read-across substance benzoic acid
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:
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
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic NOEAL of 500 mg/kg bw/day has been identified from a 90 day oral study in rats exposed to the read-across substance benzoic acid.

DNEL = 500 mg/kg bw/day / (4 interspecies factor (allometric acaling) x 2.5 interspecies factor x 5 intraspecies factor x 2 duration factor) = 5 mg/kg bw/day

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
subchronic exposure
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
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:
0.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEC
Value:
250 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
62.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

A systemic NOEAC of 250 mg/m3 has been identified from a 28 day inhalation study in rats exposed to the read-across substance benzoic acid.

Corrected NOEAC = 250 mg/m3 x 6h/24 h = 62.5 mg/m3

DNEL = 62.5 mg/m3 / (2.5 interspecies factor x 10 intraspecies factor x 6 duration factor) = 0.4 mg/m3

AF for dose response relationship:
1
Justification:
NOAEC
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
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:
0.013 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
450
Dose descriptor:
LOAEC
Value:
25 mg/m³
AF for dose response relationship:
3
Justification:
LOAEC to NOAEC
AF for differences in duration of exposure:
6
Justification:
from subacute to chronic
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
A LOAEC of 25 mg/m3 based on local effects in the lung has been identified from a 28 day inhalation study in rats exposed to the read-across substance benzoic acid

LOAEC crrected = 25 mg/m3 x 6h/24h = 6 mg/m3 (effect considered dependant on total daily pulmonary deposition of particles (i.e. total daily dose) of low solubility)

DNEL = 6 mg/m3 / (2.5 (interspecies) x 10 (intraspecies) x 6 (duration) x 3 (LOAEC to NOAEC)) = 0.013 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:
2.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic NOEAL of 500 mg/kg bw/day has been identified from a 90 day oral study in rats exposed to the read-across substance benzoic acid.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
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:
2.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A systemic NOEAL of 500 mg/kg bw/day has been identified from a 90 day oral study in rats exposed to the read-across substance benzoic acid.

AF for differences in duration of exposure:
2
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
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