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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.4 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:
0.7 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

Vanadyl pyrophosphate is used in industrial applications as a catalyst, thus it is handled during loading, unloading or maintenance of reactors.

Therefore, long-term dermal and inhalative intakes are the possible exposure routes for worker, while a contact for the general public can be excluded.

 

In addition to the assessment of the long-term effects, a qualitative assessment according to “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, May 2008) of

the local effects of vanadyl pyrophosphate needs to be performed, since it was found to be irritating to eyes as well as sensitising. Appropriate risk management measures need to be identified.

 

The DNEL for oral and dermal long-term exposure are derived from the no observed effect level obtained in a 28-day oral repeated dose toxicity study performed according to OECD guideline 407. Based on the observed mortality and clinical findings, the NOAEL was found to be 200 mg/kg bw/d.

 

For calculation of the DNEL for long-term inhalation systemic effects, route-to-route extrapolation was performed in order to take into account differences between rat and human exposure conditions. Therefore, the no observed effect level was corrected by 1/0.38 and 6.7/10 regarding breathing volume and frequency. Thus, the corrected starting point for workers was 176.3 mg/m3/d for inhalation

 

Subsequently other assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (6). An additional assessment factor (2) was used to consider the different absorption properties of the respiratory tract and after oral intake.

The DNEL is calculated according to the formula DNEL = (corrected starting point)/(overall AF). Thus, the resulting DNEL for long-term inhalative systemic effects of vanadyl pyrophosphate is 2.4 mg/m3for workers.

For the DNEL of systemic oral effects a correction of the starting point is not required, since the observed effect level was derived in a 28-day oral repeated dose toxicity study.

Subsequently, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (6).

As a consequence, the resulting DNEL for long-term dermal systemic effects is 0.7 mg/kg bw/d for workers.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Vanadyl pyrophosphate is only used in industrial applications as a catalyst, thus it is handled during loading, unloading or maintenance of reactors.

Due to the exclusively industrial use of vanadyl pyrophosphate, a contact by the general public can be excluded. Therefore, DNELs for the general population have not been derived.