Registration Dossier
Registration Dossier
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EC number: 940-733-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 500 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1
- 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:
- 300 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 16
- 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
In studies in rodents, 8 hours of exposure to n-decane (Lammers et al., 2010) produced limited evidence of acute CNS effects at 5000 mg/m3 with 1500 mg/m3 as a no effect level. Similar results were obtained with a C9-C11 isoparaffinic solvent (Lammers et al., 2001a). A C10 cycloparaffinic solvent also produced limited evidence of CNS effects at 5000 mg/m3, but the no effect level was established at 2500 mg/m3 (Lammers et al. 2001b).
In other studies, n-alkanes containing more than 9 carbons were reported as without effect in 8 hour studies of acute CNS effects in rats at levels up to the maximally attainable vapor concentrations (Nilsen et al., 1988). Similarly, it was reported that isoparaffinic solvents containing 9 or more carbons could not form stable vapor concentrations at levels which could produce acute CNS effects in mice in 30 minutes (Bowen and Balster).
Dermal and inhalation are the relevant routes of exposure. Aspiration is a potential hazard, but a DNEL calculation is not appropriate for an aspiration hazard.
Workers are expected to have infrequent and short-term exposures; however, for calculation of the DNEL for REACH purposes it is assumed that workers have maximal repeated exposure for 8 hr/day for 5 day/wk.
In summary the animal and human data indicate that the worker long term inhalation DNEL 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 for publication)
Lammers, J. et al. (2001a). The effects of short term inhalatory exposure to Isane IP 155 on behavior in the rat. TNO Report V99.1111 (unpublished data).
Lammers, J. et al. (2001b). The effects of short-term inhalatory exposure to Nappar 10 on behavior in the rat. TNO Report V99.1112. (unpublished data).
Nilsen, O. et al. (1988). Toxicity of n-C9 to n-C13 alkanes in the rat on short term inhalation. Pharmacology and Toxicology 62:259-266.
Bowen, S. and Balster, R. (1998). The effects of inhaled isoparaffins on locomotor activity and operant performance in mice. Pharmacology, Biochemistry and Behavior 61:271-280.
McKee, R., et al. (2010). Neurobehavioral effects of acute exposure to aromatic hydrocarbons. International Journal of Toxicology in press.
Korsak, K. et al. (1998). Toxic effects of acute inhalation exposure to 1-methylnaphthalene and 2-methylnaphthalene in experimental animals. International Journal of Occupational Medicine and Environmental Health 11:335-342.
Carpenter, C. et al. (1975). Petroleum hydrocarbon toxicity studies VII. Animal and human response to vapors of “70 solvent.” Toxicology and Applied Pharmacology 34:395-412.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 900 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1
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:
- 300 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 16
- 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:
- 300 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 16
- 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
In studies in rodents, 8 hours of exposure to n-decane (Lammers et al., 2010) produced limited evidence of acute CNS effects at 5000 mg/m3 with 1500 mg/m3 as a no effect level. Similar results were obtained with a C9-C11 isoparaffinic solvent (Lammers et al., 2001a). A C10 cycloparaffinic solvent also produced limited evidence of CNS effects at 5000 mg/m3, but the no effect level was established at 2500 mg/m3 (Lammers et al. 2001b).
In other studies, n-alkanes containing more than 9 carbons were reported as without effect in 8 hour studies of acute CNS effects in rats at levels up to the maximally attainable vapor concentrations (Nilsen et al., 1988). Similarly, it was reported that isoparaffinic solvents containing 9 or more carbons could not form stable vapor concentrations at levels which could produce acute CNS effects in mice in 30 minutes (Bowen and Balster).
Dermal and inhalation are the relevant routes of exposure. An oral DNEL was calculated for use in an indirect exposure assessment; the oral route is not expected to be a significant exposure route. Aspiration is a potential hazard, but a DNEL calculation is not appropriate for an aspiration hazard.
Consumers in the general population are expected to have infrequent and short-term exposures. However, for calculation of DNELs for REACH, it is assumed that consumers have a maximal repeated dose for 24 hr/day for 7 day/wk.
References:
Lammers, J. et al. (2010). Neurobehavioral effects of acute exposure to normal (n-) paraffins. International Journal of Toxicology (submitted for publication)
Lammers, J. et al. (2001a). The effects of short term inhalatory exposure to Isane IP 155 on behavior in the rat. TNO Report V99.1111 (unpublished data).
Lammers, J. et al. (2001b). The effects of short-term inhalatory exposure to Nappar 10 on behavior in the rat. TNO Report V99.1112. (unpublished data).
Nilsen, O. et al. (1988). Toxicity of n-C9 to n-C13 alkanes in the rat on short term inhalation. Pharmacology and Toxicology 62:259-266.
Bowen, S. and Balster, R. (1998). The effects of inhaled isoparaffins on locomotor activity and operant performance in mice. Pharmacology, Biochemistry and Behavior 61:271-280.
McKee, R., et al. (2010). Neurobehavioral effects of acute exposure to aromatic hydrocarbons. International Journal of Toxicology in press.
Korsak, K. et al. (1998). Toxic effects of acute inhalation exposure to 1-methylnaphthalene and 2-methylnaphthalene in experimental animals. International Journal of Occupational Medicine and Environmental Health 11:335-342.
Carpenter, C. et al. (1975). Petroleum hydrocarbon toxicity studies VII. Animal and human response to vapors of “70 solvent.” Toxicology and Applied Pharmacology 34:395-412.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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