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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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