Registration Dossier
Registration Dossier
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EC number: 442-600-9 | 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:
- 1.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- 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:
- 0.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The test substance HiTEC 7134 is intended to be used as a fuel additive product. The concentration of the substance in the product is low, and it will be further diluted when added to the fuel tank of a car. The available acute dermal and oral toxicity tests show that HiTEC 7134 is not acutely toxic since both LD50 values are >2000 mg/kg bw, the highest concentration tested. Therefore, the substance does not need to be classified for acute toxicity. An acute or repeated-dose inhalation study was not performed due to the physical-chemical properties of the substance. A very high log Kow and a low pressure, of 6.4 and 0.00002 Pa respectively, make the generation of vapors or aerosols unfeasible. From the available oral 28 days repeated-dose toxicity study with rats, performed in 2001 by Central Toxicology Laboratory and a repeated dose reproductive study completed in 2012 by NOTOX B.V., a NOAEL was derived of 120 mg/kg bw/day. This starting point was chosen to derive all long-term DNELs, including dermal, inhalation and oral. Using this starting point, extrapolation was made for the inhalation and dermal route, and the derived long-term safety values are considered sufficient to fully protect consumers and workers from a potential systemic exposure to HiTEC7134. Regarding potential local effects due to exposure to the test substance, no safety levels were derived. From the available information, no threshold effect can be used for the derivation of a DNEL since only single concentrations were tested (in the skin irritation and acute dermal tests). The inhalation DNEL for local effects was waived based on lack of exposure. As mentioned before, it is highly unlikely that workers or the general population will be exposed to the substance by inhalation, due to the very low vapor pressure and low concentrations of exposure. Consequently, a exposure based waiving is justifiable for this substance for local effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.05 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- 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:
- 0.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- 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:
- 0.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
See above. Also for full text not limited by maximum character limit of fields see attached document entitled: DNEL derivations HiTEC 7134 Performance Additive
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.
