Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
22.04 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-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.41 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
43
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

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). Neodecanoic acid is not classified for acute toxicity; oral, dermal or inhalation. 

 

Irritation

Neodecanoic acid is not classified as a skin irritant.  A DNEL is not required for this endpoint. 

 

Sensitization

Neodecanoic acid is not classified as a sensitizer. A DNEL is not required for this endpoint.   

 

Genetic toxicity

Neodecanoic acid is not classified as a genotoxic or mutagenic. A DNEL is not required for this endpoint. 

 

Reproductive and Developmental toxicity

Neodecanoic acid 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 400 mg/kg/day; from a well described repeated dose dermal study.

 

Modification of dose descriptor

= dermal NOAEL * (animal exposure / worker exposure) * (animal days / worker days)

= 400 * (8 / 8) * (4 / 5)

dermal NOAEL = 320 mg/kg/day

 

Adjustment factors (ECETOC Technical Report #86):         

 

Criteria

Adjustment Factor

Allometric scaling - rabbit

2.4

Intraspecies - workers

3

Subacute study to Chronic    

6

Overall Adjustment Factor

43.2

 

           

                                   

 

DNEL calculation

DNEL dermal = dermal NOAEL / (adjustment factors)

DNEL dermal = 320 mg/kg/day / (2.4 * 3 * 6)

DNEL dermal = 7.41 mg/kg/day

 

Inhalation

Dose descriptor = NOAEL of 75/mg/kg/day; from a well described 3-generation reproduction and development study

 

Route-to-route extrapolation (calculation B.3 in ECHA Guidance R.8)

inhalatory NOAEC = oral LOAEL * (1/ sRV rat 8h) * (ABS oral / ABS inh) * (sRV human / wRV)

inhalatory NOAEC= 75 * (1/0.38) * (100/100) * (6.7 / 10)

inhalatory NOAEC = 132.24 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 = 132.24 mg/m3 / (6)

DNEL inhalation = 22.04 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.52 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
10
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.06 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.88 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-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

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). Neodecanoic acid is not classified for acute toxicity; oral, dermal or inhalation. 

 

Irritation

Neodecanoic acid is not classified as a skin irritant.  A DNEL is not required for this endpoint. 

 

Sensitization

Neodecanoic acid is not classified as a sensitizer. A DNEL is not required for this endpoint.   

 

Genetic toxicity

Neodecanoic acid is not classified as a genotoxic or mutagenic. A DNEL is not required for this endpoint. 

 

Reproductive and Developmental toxicity

Neodecanoic acid 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 400 mg/kg/day; from a well described repeated dose dermal study.

 

Modification of dose descriptor

= dermal NOAEL * (animal exposure / worker exposure) * (animal days / worker days)

= 400 * (8 / 24) * (4 / 7)

dermal NOAEL = 76.19 mg/kg/day

 

Adjustment factors (ECETOC Technical Report #86):

Criteria

Adjustment Factor

Allometric scaling - rabbit

2.4

Intraspecies – general population

5

Subacute study to Chronic    

6

Overall Adjustment Factor

72

 

DNEL calculation

DNEL dermal = dermal NOAEL / (adjustment factors)

DNEL dermal = 76.19 mg/kg/day / (2.4 * 5 * 6)

DNEL dermal = 1.06 mg/kg/day

 

 

Inhalation

Dose descriptor = NOAEL of 75/mg/kg/day; from a well described 3-generation reproduction and development 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= 75 * (1/1.15) * (100/100)

inhalatory NOAEC = 65.22 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 = 65.22 mg/m3 / (10)

DNEL inhalation = 6.52 mg/m3

 

Oral

Dose descriptor = NOAEL of 75/mg/kg/day; from a well described 3-generation reproduction and development 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 = 75 mg/kg/day / (40)

DNEL oral = 1.88 mg/kg/day