Registration Dossier
Registration Dossier
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EC number: 421-090-1 | CAS number: 131298-44-7 Isodecyl benzoate
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 181 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
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:
- 206 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
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
Acute toxicity
A DNEL for acute toxicity should be derived if an acute hazard leading to acute toxicity (e.g. C&L) has been identified and there is a potential for high peak exposures. These “peaks” are normally associated with inhalation exposure but are less common for skin contact and ingestion (Appendix R.8-8). Isodecyl benzoate is not classified for acute toxicity; oral, dermal or inhalation.
Irritation
Isodecyl benzoate is not classified as a skin irritant. A DNEL is not required for this endpoint.
Sensitization
Isodecyl benzoate is not classified as a sensitizer. A DNEL is not required for this endpoint.
Genetic toxicity
Isodecyl benzoate is not classified as a genotoxic or mutagenic. A DNEL is not required for this endpoint.
Reproductive and Developmental toxicity
Isodecyl benzoate is not classified as a reproductive or developmental toxin. A DNEL is not required for this endpoint.
Long-term systemic effects
The potential of a substance to cause long-term systemic effects can judged based on the results of repeated dose toxicity testing. The following DNELs are conservative by nature and are protective of all adverse effects.
Dermal - Systemic
Dose descriptor = NOAEL of 619 mg/kg/day; from a well described repeated dose oral study.
Modification of dose descriptor
= dermal NOAEL * (animal exposure / worker exposure) * (animal days / worker days) * (oral abs / dermal abs)
= 619 * (8 / 8) * (4 / 5) * (100/10)
dermal NOAEL = 4952 mg/kg/day
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
4 |
Intraspecies - workers |
3 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
24 |
DNEL calculation
DNEL dermal = dermal NOAEL / (adjustment factors)
DNEL dermal = 4952 mg/kg/day / (24)
DNEL dermal = 206 mg/kg/day
Inhalation
Dose descriptor = NOAEL of 619 mg/kg/day; from a well described repeated dose oral study.
Route-to-route extrapolation (calculation B.3 in ECHA Guidance R.8)
inhalatory NOAEC = oral NOAEL * (1/ sRV rat 8h) * (ABS oral / ABS inh) * (sRV human / wRV)
inhalatory NOAEC= 619 * (1/0.38) * (100/100) * (6.7 / 10)
inhalatory NOAEC = 1091 mg/m3
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
not applied |
Intraspecies - workers |
3 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
6 |
DNEL calculation
DNEL inhalation = inhalation NOAEC / (adjustment factors)
DNEL inhalation = 1091 mg/m3 / (6)
DNEL inhalation = 181 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 53 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
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:
- 15.48 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
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
Acute toxicity
A DNEL for acute toxicity should be derived if an acute hazard leading to acute toxicity (e.g. C&L) has been identified and there is a potential for high peak exposures. These “peaks” are normally associated with inhalation exposure but are less common for skin contact and ingestion (Appendix R.8-8). Isodecyl benzoate is not classified for acute toxicity; oral, dermal or inhalation.
Irritation
Isodecyl benzoate is not classified as a skin irritant. A DNEL is not required for this endpoint.
Sensitization
Isodecyl benzoate is not classified as a sensitizer. A DNEL is not required for this endpoint.
Genetic toxicity
Isodecyl benzoate is not classified as a genotoxic or mutagenic. A DNEL is not required for this endpoint.
Reproductive and Developmental toxicity
Isodecyl benzoate is not classified as a reproductive or developmental toxin. A DNEL is not required for this endpoint.
Long-term systemic effects
The potential of a substance to cause long-term systemic effects can judged based on the results of repeated dose toxicity testing. The following DNELs are conservative by nature and are protective of all adverse effects.
Dermal - Systemic
Dose descriptor = NOAEL of 619 mg/kg/day; from a well described repeated dose oral study.
Modification of dose descriptor
= dermal NOAEL * (animal exposure / worker exposure) * (animal days / worker days) * (oral abs / dermal abs)
= 619 * (8 / 24) * (4 / 7) * (100 / 10)
dermal NOAEL = 1179 mg/kg/day
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
4 |
Intraspecies – general population |
5 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
40 |
DNEL calculation
DNEL dermal = dermal NOAEL / (adjustment factors)
DNEL dermal = 1179 mg/kg/day / (40)
DNEL dermal = 29 mg/kg/day
Inhalation
Dose descriptor = NOAEL of 619 mg/kg/day; from a well described repeated dose oral study.
Route-to-route extrapolation (calculation B.3 in ECHA Guidance R.8)
inhalatory NOAEC = oral NOAEL * (1/ sRV rat 24h) * (ABS oral / ABS inh)
inhalatory NOAEC= 619 * (1/1.15) * (100/100)
inhalatory NOAEC = 538.26 mg/m3
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
not applied |
Intraspecies – General Population |
5 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
10 |
DNEL calculation
DNEL inhalation = inhalation NOAEC / (adjustment factors)
DNEL inhalation = 538.26 mg/m3 / (10)
DNEL inhalation = 53.83 mg/m3
Oral
Dose descriptor = NOAEL of 619 mg/kg/day; from a well described repeated dose oral study.
Modification of dose descriptor: Not required
Adjustment factors (ECETOC Technical Report #86):
Criteria |
Adjustment Factor |
Allometric scaling - rat |
4 |
Intraspecies – General Population |
5 |
Subchronic study to Chronic |
2 |
Overall Adjustment Factor |
40 |
DNEL calculation
DNEL oral = oral NOAEL / (adjustment factors)
DNEL oral = 619 mg/kg/day / (40)
DNEL oral = 15.48 mg/kg/day
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