Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 085 mg/m³
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:
300 mg/kg bw/day
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

The pattern of identified uses described for hydrocarbons, C7, n-alkanes, isoalkanes, cyclics includes short-term peak exposure by inhalation and the dermal route as well as long-term repeated exposure by inhalation and the dermal route. In the case of short-term exposure, it is not possible to derive a DNEL for systemic effects, since CNS toxicity (narcotic effects) and local irritation on the skin are the leading effects.Therefore, appropriate risk management measures will be identified.

 

EU (2000). European Commission Directive 2000/39/EC of 8 June 2000 establishing a first list of indicative occupational exposure limit values in implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work.

 

CNS Effects

In studies in rodents, 8 hours of exposure to n-octane (Lammers et al., 2010) did not produce any acute CNS effects at levels up to 14,000 mg/m3. Similarly, there were no acute CNS effects associated with exposure to iso-octane for 8 hours at 14,000 mg/m3 (Lammers et al., 2001a). In a study of a mixed C7 cycloparaffinic solvent, there was evidence of acute CNS effects at 14,000 mg/m3, but no effects at 4200 mg/m3 (Lammers et al., 2001a). In older studies, the anaesthetic levels for n-heptane and iso-octane in mice were reported as greater than 8000 ppm (approximately 32,000 mg/m3 ) (Swan et al., 1974).

 

In humans heptane was reported to produce a slight vertigo in 6 minutes at a concentration of 1000 ppm (approximately 4000 mg/m3) (Patty and Yant, 1929).

 

In summary the animal and human data indicate that the worker long term inhalation DNEL (approximately 2000 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 exposures to(n-) paraffins. International Journal of Toxicology (submitted for publication).

 

Lammers, J. et al. (2001a). The effects of short term inhalatory exposure to iso-octane on behavior in the rat. TNO Report V99.430. (unpublished laboratory report).

 

Lammers, J. et al. (2001b). The effects of short-term inhalatory exposure to Cypar 7 on behavior in the rats. TNO Report V99.1115. (unpublished laboratory report).

 

Swan, H. et al. (1974). Acute inhalation toxicology of volatile hydrocarbons. American Industrial Hygiene Association Journal 35:511-518.

 

Patty, F., and Yant, W. (1929). Odor intensity and symptoms produced by commercial propane, butane, pentane, hexane and heptane. Bureau of Mines. R.I. 2979.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
447 mg/m³
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:
149 mg/kg bw/day
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:
149 mg/kg bw/day
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

The pattern of identified uses described for hydrocarbons, C7, n-alkanes, isoalkanes, cyclics includes short-term peak exposure by inhalation and the dermal route as well as long-term repeated exposure by inhalation and the dermal route. In the case of short-term exposure, it is not possible to derive a DNEL for systemic effects, since CNS toxicity (narcotic effects) and local irritation on the skin are the leading effects.Therefore, appropriate risk management measures will be identified.

 

The assessment factors used to derive the relevant DNELs were taken from ECETOC 2003 and other, more recent, information.

 

CNS Effects

In studies in rodents, 8 hours of exposure to n-octane (Lammers et al., 2010) did not produce any acute CNS effects at levels up to 14,000 mg/m3. Similarly, there were no acute CNS effects associated with exposure to iso-octane for 8 hours at 14,000 mg/m3 (Lammers et al., 2001a). In a study of a mixed C7 cycloparaffinic solvent, there was evidence of acute CNS effects at 14,000 mg/m3, but no effects at 4200 mg/m3 (Lammers et al., 2001a). In older studies, the anaesthetic levels for n-heptane and iso-octane in mice were reported as greater than 8000 ppm (approximately 32,000 mg/m3 ) (Swan et al., 1974).

 

In humans heptane was reported to produce a slight vertigo in 6 minutes at a concentration of 1000 ppm (approximately 4000 mg/m3) (Patty and Yant, 1929).

 

In summary the animal and human data indicate that the worker long term inhalation DNEL (approximately 2000 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 exposures to(n-) paraffins. International Journal of Toxicology (submitted for publication).

 

Lammers, J. et al. (2001a). The effects of short term inhalatory exposure to iso-octane on behavior in the rat. TNO Report V99.430. (unpublished laboratory report).

 

Lammers, J. et al. (2001b). The effects of short-term inhalatory exposure to Cypar 7 on behavior in the rats. TNO Report V99.1115. (unpublished laboratory report).

 

Swan, H. et al. (1974). Acute inhalation toxicology of volatile hydrocarbons. American Industrial Hygiene Association Journal 35:511-518.

 

Patty, F., and Yant, W. (1929). Odor intensity and symptoms produced by commercial propane, butane, pentane, hexane and heptane. Bureau of Mines. R.I. 2979.

 

ECETOC (2003). Derivation of assessment factors for human health risk assessment. Technical report No. 86, (European Centre for Ecotoxicology and Toxicology of Chemicals).