Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 235-795-5 | CAS number: 12738-64-6
Toxicological Summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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