Registration Dossier

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