Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.64 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
adequate data available
AF for differences in duration of exposure:
1
Justification:
An AF is not necessary for differences in duration of exposure, because the starting point is derived based on human data covering exposure durations of several years (up to about 11 years) and is based on a robust dataset of workroom air measurements.
AF for interspecies differences (allometric scaling):
1
Justification:
An AF for allometric scaling does not need to be considered because of local irritation effects.
AF for other interspecies differences:
1
Justification:
An AF is not needed for inter-species variability and for remaining differences, because human data served as the starting point.
AF for intraspecies differences:
1
Justification:
An AF is not considered necessary for intra-species variability, because there is no difference between the population in the source data (workers exposed to V2O5 dust) and the target population (workers of the vanadium industry), and it can be expected that the susceptibility of workers to the effect of local irritation is equally distributed across the subpopulation, and human variability due to toxicokinetic factors can be regarded as limited.
AF for the quality of the whole database:
1
Justification:
A further AF is not considered for quality of the whole database, because sufficient human and animal data are available. The POD selected was based on a NOAEC for cytology from nasal smears of workers a sensitive endpoint for nasal irritation and is thus protective.
AF for remaining uncertainties:
1
Justification:
A further AF is not considered because sufficient human and animal data are available. The POD selected was based on a NOAEC for cytology from nasal smears of workers a sensitive endpoint for nasal irritation and is thus protective.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

For further detail, please refer to the attached document "Derivation of DNEL values for vanadium substances.pdf" (2014).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1.7
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
An AF is not used for the dose-response as the NOAEC is used as starting point.
AF for differences in duration of exposure:
1
Justification:
An AF is not necessary for differences in duration of exposure because the starting point is derived based on human data covering exposure durations of several years (up to about 11 years) and is based on a robust dataset of exposure measurements.
AF for interspecies differences (allometric scaling):
1
Justification:
An AF for allometric scaling does not need to be considered because of local irritation effects.
AF for other interspecies differences:
1
Justification:
An AF is not needed for inter-species variability and for remaining differences because human data served as the starting point.
AF for intraspecies differences:
1.7
Justification:
An AF of 5 is considered sufficient for intra-species variability within the general population, because, although it can be expected that the susceptibility of the general population to the effect of local irritation might be equally distributed across human subjects, and human variability due to toxicokinetic factors can be regarded as limited, there is still some uncertainty remaining because of the variability in the different subgroups of the general population. As these data were derived from workers, the variability in chemical sensitivity in humans (AF=3) is included in the data and needs to be considered.
AF for the quality of the whole database:
1
Justification:
A further AF is not considered for quality of the whole database because sufficient human and animal data are available.
AF for remaining uncertainties:
1
Justification:
A further AF is not considered because sufficient human and animal data are available.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.64 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Modified dose descriptor starting point:
LOAEL
DNEL value:
24 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route to route extrapolation performed
AF for dose response relationship:
3
Justification:
Although the observed effects were minimal, a 3 fold factor was included to be protective.
AF for differences in duration of exposure:
1
Justification:
chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Factor for allometric scaling: any metabolism of inorganic substances can be excluded. Therefore, it is considered justified to deviate from default assessment factors accounting for a correction for differences in metabolic rate by assigning a factor of “1” instead of using the default factor of 4.
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
The assessment factor is introduced since it is expected that a greater variability in response from the most to least sensitive human would be seen, relative to an experimental animal population. ECETOC (2003) has reviewed scientific literature on the distribution of human data for various toxicokinetic and toxicodynamic parameters to assess intraspecies variability within the human population, specifically by Renwick and Lazarus (1998) and Hattis et al. (1999). Considering that the data analysed by these authors include both sexes, a variety of disease states and ages, the use of the 95th percentile of the distribution of the variability for these datasets is considered sufficiently conservative to account for intra-species variability for the general population. Based on this, a default assessment factor of 5 is recommended by ECETOC (2003) for the general population.
AF for the quality of the whole database:
1
Justification:
Several supportive studies exist
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

For further detail, please refer to the attached document "Derivation of DNEL values for vanadium substances.pdf" (2014).