Registration Dossier
Registration Dossier
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EC number: 928-812-9 | 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:
- 165 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12
- 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:
- 22 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 48
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
In instances where stable aerosol formation is expected, a value of 10 mg/m3 will be used as an operational control limit for inhalation exposure.
The potential exposure to the test material indicates that long-term exposure DNELs need to be derived for workers and for the general population. No acute toxicity was noted in any of the toxicological studies conducted. Additionally, DNELs derived for chronic exposures are typically lower than those calculated for acute exposures and would therefore be protective of human for both the acute and chronic exposures.
Dermal and inhalation are the relevant routes of exposure. Hydrocarbons C13 -C20 have vapor pressures that are relatively low, typically <0.01 kPa and vapor concentrations are expected to be relatively low. The likelihood of exposure to vapors from these solvents at potentially harmful levels is not expected. 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/week.
Assessment factors were chosen on the basis of ECETOC (2003) and other, more recent information. For route to route extrapolation, absorption differences were not taken into account.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 20
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:
- 13 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 80
- 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:
- 13 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 80
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
The potential exposure to the test material indicates that long-term exposure DNELs need to be derived for general population. No acute toxicity was noted in any of the toxicological studies conducted. Additionally, DNELs derived for chronic exposures are typically lower than those calculated for acute exposures and would therefore be protective of human for both the acute and chronic exposures.
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.
Assessment factors were chosen on the basis of ECETOC (2003) and other, more recent information. For route to route extrapolation, absorption differences were not taken into account.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
