Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 000 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
3
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:
432 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
3
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

The worker inhalation long-term systemic DNEL is the IOEL for pentane, isopentane and neopentane. This was converted to a dermal DNEL by multiplying it by 10 m3 (volume of air breathed in a day at work) and divided by 70 kg (the average body weight of a worker).

In studies in rodents, exposure to n-pentane (Lammers et al., 2010), iso-pentane (TNO, 2000a), and cyclo-pentane (TNO, 2000b) provided evidence that pentane isomers do not produce acute CNS effects at levels up to 20,000 mg/m3. As summarized in Lammers et al. (2010), previous investigations of the anaesthetic properties of n-pentane have established that minimal effect levels for CNS effects in rodents would be in the range of 50,000 mg/m3 – 100,000 mg/m3.

 

In early studies with human volunteers it was shown that short term exposures to levels up to 5000 ppm (approximately 15,000 mg/m3) was not problematic (Patty and Yant, 1929).

 

In summary the animal and human data indicate that the worker long term inhalation DNEL (3000 mg/m3) is also protective for short term effects including acute CNS effects and respiratory irritation.

 

References:

 

Lammers, J. et al. (2010). Neurobehavioral effects of acute exposure to normal (n-) paraffins. International Journal of Toxicology (submitted).

 

Lammers, J. (2000a). The effects of short-term inhalatory exposure to cyclopentane on behavior in the rat. TNO Report V98.1020. (unpublished laboratory report)

 

Lammers, J. (2000b). The effects of short-term inhalatory exposure to isopentane on behavior in the rat. TNO Report V98.1105. (unpublished laboratory report).

 

Patty, F. and Yant, W. (1929). Report of investigations of odor intensity and symptoms produced by commercial propane, butane, pentane, hexane and heptane vapor. Report no. 2979. US Department of Commerce, Bureau of Mines,,

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
643 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
214 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
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:
214 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
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

The general population systemic DNELs were calculated based on the IOEL for Pentane, Isopentane, and Neopentane (3,000 mg/m3).

For the general population inhalation DNEL, 3,000 mg/m3 was multiplied by 10/20 to account for differences between workers and the general public for ventilation rates, 5/7 for difference in days of the week potentially exposed, and 3/5 to account for the AF of 5 intraspecies differences in the general population.

The general population dermal and oral DNELs were calculated by multiplying the general population inhalation DNEL by 20 m3 (volume of air breathed in a day) and divided by 60 kg (the average body weight in the general population).

In studies in rodents, exposure to n-pentane (Lammers et al., 2010), iso-pentane (TNO, 2000a), and cyclo-pentane (TNO, 2000b) provided evidence that pentane isomers do not produce acute CNS effects at levels up to 20,000 mg/m3. As summarized in Lammers et al. (2010), previous investigations of the anaesthetic properties of n-pentane have established that minimal effect levels for CNS effects in rodents would be in the range of 50,000 mg/m3 – 100,000 mg/m3.

 

In early studies with human volunteers it was shown that short term exposures to levels up to 5000 ppm (approximately 15,000 mg/m3) was not problematic (Patty and Yant, 1929).

 

In summary the animal and human data indicate that the worker long term inhalation DNEL (3000 mg/m3) is also protective for short term effects including acute CNS effects and respiratory irritation.

 

References:

 

Lammers, J. et al. (2010). Neurobehavioral effects of acute exposure to normal (n-) paraffins. International Journal of Toxicology (submitted).

 

Lammers, J. (2000a). The effects of short-term inhalatory exposure to cyclopentane on behavior in the rat. TNO Report V98.1020. (unpublished laboratory report)

 

Lammers, J. (2000b). The effects of short-term inhalatory exposure to isopentane on behavior in the rat. TNO Report V98.1105. (unpublished laboratory report).

 

Patty, F. and Yant, W. (1929). Report of investigations of odor intensity and symptoms produced by commercial propane, butane, pentane, hexane and heptane vapor. Report no. 2979. US Department of Commerce, Bureau of Mines,,