Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
5 µg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6 250
Modified dose descriptor starting point:
T25
Value:
14.92 mg/m³
Explanation for the modification of the dose descriptor starting point:
According to REACH guidance, the oral absorption is assumed to be 50%, while the inhalation absorption is 100%. Adjustment of route of exposure: from rat (oral) in mg/kg/d to rat inhalation (0.8 L/min/kg; 8h): 0.384 m3/kg/8h. Activity driven difference: at rest/light activity: 6.7/10 in line with the 10m3 approach. Difference between occupational and lifetime exposure conditions: 2.8
Justification:
The high to low dose extrapolation factor of 6250 is used according to the proposal of the workshop DMEL and risks in occupational exposure to carcinogenic compounds, Dortmund 17.05.2011. A risk level of 4 : 100 000 is proposed as a conservative approach pending a harmonised risk level is determined. The corresponding assessment factor is 6250 when the starting point is a T25 (i.e. 100 000/4*25%).
AF for differences in duration of exposure:
1
Justification:
It is usually assumed that studies shorter than the lifespan of the animals will underestimate the number of tumours found in the study. However this assumption does not apply to quinoline studies because the tumour pattern is rather unusual: there is a very high incidence of tumours with an early onset leading to a dramatic reduction of the survival of the animals. according to Hirao's study, the exposure to 0.05% in diet for 40 weeks iinduces tumours in 82% of the animals, the corresponding mean survival is 36.5 +/- 0.5 weeks. Consequently no correction for lifespan duration is applied.
Justification:
See the justification for route to route extrapolation.
Justification:
See the justification for route to route extrapolation.
Justification:
See the justification for route to route extrapolation.
AF for the quality of the whole database:
1
Justification:
Information is available about the carcinogenic properties of quinoline
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
0.24 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25 000
Modified dose descriptor starting point:
T25
Value:
6.11 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The dermal absorption is considered the same as the oral absorption so the T25 value from the oral carcinogenicity study is used as the starting point for the calculation of the dermal DMEL.
Justification:
The high to low dose extrapolation factor of 6250 is used according to the proposal of the workshop DMEL and risks in occupational exposure to carcinogenic compounds, Dortmund 17.05.2011. A risk level of 4 : 100 000 is proposed as a conservative approach pending a harmonised risk level is determined. The corresponding assessment factor is 6250 when the starting point is a T25 (i.e. 100 000/4*25%).
AF for differences in duration of exposure:
1
Justification:
It is usually assumed that studies shorter than the lifespan of the animals will underestimate the number of tumours found in the study. However this assumption does not apply to quinoline studies because the tumour pattern is rather unusual: there is a very high incidence of tumours with an early onset leading to a dramatic reduction of the survival of the animals. according to Hirao's study, the exposure to 0.05% in diet for 40 weeks iinduces tumours in 82% of the animals, the corresponding mean survival is 36.5 +/- 0.5 weeks. Consequently no correction for lifespan duration is applied.
AF for interspecies differences (allometric scaling):
4
Justification:
According to REACH guidance
AF for other interspecies differences:
1
Justification:
According to REACH guidance
AF for intraspecies differences:
1
Justification:
According to REACH guidance
AF for the quality of the whole database:
1
Justification:
Information is available about the carcinogenic properties of quinoline
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Quinoline is not available in consumer products and is not released in the environment. So it's not necessary to set DN(M)EL for the general population.