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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
139 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
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Conclusions for toxicological properties of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) are based on read-across from analogue substances of an existing category (pentaerythritol and dipentaerythritol esters), of which the members were notified under Directive 67/548/EEC (NONS) in 2003/2004.

In view of the structural similarities and similar physicochemical properties of the substance of interest with the other substances in the category, DNEL's can be read-across. DNEL's for Hatcol 1106 were derived by read across from CAS 7299 -99 -2, a hexa ester of pentaeryhtritol.

Since no local effects were noted after oral, dermal or eye exposure, local DNELs were not derived.

As an acute toxicity hazard leading to Classification and Labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, Draft new chapter B.8 Scope of Exposure Assessment, March 2010).

 

The following DNELs for workers were derived:

Systemic:

Long-term inhalation

Long-term dermal

  

Route-to-route extrapolation

For the derivation of the DNELs:

Long-term – dermal, systemic effects

Long-term – inhalation, systemic effects

 

Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).

Absorption oral (rat) = Absorption oral (human) = 100%

Absorption dermal (human) = 10%

Absorption inhalation (human) = 100%

 

The DNELs for human exposure are derived according to the ECETOC guidance (final draft).

 

Long-term inhalation, systemic effects

Worker

Starting point: NOAEL 1000 mg/kg bw/day from a 28-day oral study in rats.

 

Route-to-route extrapolation:

Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 100/100 = 1000 mg/kg bw

 

Corrected inhalatory NOAEC = 1000 x 1/0.38ax 6.7/10b= 1763 mg/m3

 

astandard respiratory volume of rats for 8 hours;bstandard human respiratory volume/respiratory volume for worker with light activity.

 

Safety factors:

-         Interspecies extrapolation: 4

-         Intraspecies extrapolation: 3

-         Exposure duration: 6 (assuming chronic worker exposure)

-         Dose response: 1

-         Quality of the data base: 1

Total safety factor: 72

 

Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker, is set at 24.5 mg/m3.

 

Long-term dermal, systemic effects

Worker

Starting point: NOAEL 1000 mg/kg bw/day from a 28-day oral study in rats.

 

Route-to-route extrapolation:

Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000* 100/10 = 10000 mg/kg bw

 

Safety factors:

-         Interspecies extrapolation: 4

-         Intraspecies extrapolation: 3

-         Exposure duration: 6 (assuming chronic worker exposure)

-         Dose response: 1

-         Quality of the data base: 1

Total safety factor: 72

 

Based on the above, the long-term DNEL for systemic effects after dermal worker exposure is set at 139 mg/kg bw/day.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.25 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
83.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Conclusions for toxicological properties of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) are based on read-across from analogue substances of an existing category (pentaerythritol and dipentaerythritol esters), of which the members were notified under Directive 67/548/EEC (NONS) in 2003/2004.

In view of the structural similarities and similar physicochemical properties of the substance of interest with the other substances in the category, DNEL's can be read-across. DNEL's for Hatcol 1106 were derived by read across from CAS 7299 -99 -2, a hexa ester of pentaeryhtritol.

Since no local effects were noted after oral, dermal or eye exposure, local DNELs were not derived.

As an acute toxicity hazard leading to Classification and Labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, Draft new chapter B.8 Scope of Exposure Assessment, March 2010).

 

The following DNELs for the general population were derived:

Systemic:

Long-term oral

Long-term inhalation

Long-term dermal

  

Route-to-route extrapolation

For the derivation of the DNELs:

Long-term – dermal, systemic effects

Long-term – inhalation, systemic effects

 

Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).

Absorption oral (rat) = Absorption oral (human) = 100%

Absorption dermal (human) = 10%

Absorption inhalation (human) = 100%

 

The DNELs for human exposure are derived according to the ECETOC guidance (final draft).

 

 

Long-term oral, systemic effects

General population

 

Starting point: NOAEL 1000 mg/kg bw/day from a 28-day oral study in rats.

 

Safety factors:

-         Interspecies extrapolation: 4

-         Intraspecies extrapolation: 5

-         Exposure duration: 6 (assuming chronic exposure of the general population)

-         Dose response: 1

-         Quality of the data base: 1

Total safety factor: 120

 

Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population, is set at 8.3 mg/kg bw/d.

 

 

Long-term inhalation, systemic effects

General population

Starting point: NOAEL 1000 mg/kg bw/day from a 28-day oral study in rats

 

Route-to-route extrapolation:

Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 100/100 = 1000 mg/kg bw

 

Corrected inhalatory NOAEC = 1000 * 1/1.15a= 870 mg/m3

 

astandard respiratory volume of rats for 24 hours.

 

Safety factors:

-         Interspecies extrapolation: 4

-         Intraspecies extrapolation: 5

-         Exposure duration: 6 (assuming chronic exposure of the general population)

-         Dose response: 1

-         Quality of the data base: 1

Total safety factor: 120

 

Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the general population is set at 7.25 mg/m3.

 

 

Long-term dermal, systemic effects

General population

Starting point: NOAEL 1000 mg/kg bw/day from a 28-day oral study in rats.

 

Route-to-route extrapolation:

Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000 * 100/10 = 10000 mg/kg bw

 

Safety factors:

-         Interspecies extrapolation: 4

-         Intraspecies extrapolation: 5

-         Exposure duration: 6 (assuming chronic exposure of the general population)

-         Dose response: 1

-         Quality of the data base: 1

Total safety factor: 120

 

Based on the above, the long-term DNEL for systemic effects after dermal exposure of the general population is set at 83.3 mg/kg bw/day.