Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Evaluation of the long-term exposure is based on the breakdown product: HCl and VO2. VO2 is not classified dangerous and no exposure assessment was realised in the registration dossier. For HCl, no hazard is identified in the registration dossier.

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:
8 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

VCl4 is not a stable vanadium chloride. Its decomposition is driven by heat, dissolved Cl2 concentration, humidity or light, following the equation:

VCl4 + H2O => VOCl2 + 2 HCl

This dissolution reaction with humidity (body humidity...) is exothermic, instantaneous (half-life of VCl4 < 1 hour – VCl4 can be considered as a hydrolytically unstable substance). Then the decomposition follows the equations:

2VOCl2+ 2H2O => 2VO2+ 4HCl

That is why no data is available for VCl4 as such and in solution V2O4 is stable in the form of V4+.

2VCl4 + 4H2O => 2VO2+ 8HCl

 

On the basis of these reactions and considering the atmosphere and body humidity, we can consider that the human is exposed to HCl and VO2. The HCl exposure explains the corrosive aspect of VCl4 (reaction with the humidity of the skin or the upper respiratory tract). At the end, substances in organism are breakdown substances: HCl and VO2.

 

In conclusion, the approach for the hazard characterization of VCl4 is 

1.    Short term toxicity and local toxicity endpoints were waived, based on corrosive potential and for animal welfare considerations,

2.    Repeated toxicity, reprotoxicity and genotoxicity endpoints were based on degradation products; HCl and VO2 (annex V of REACH regulation). In its registration dossier, VO2 (n°CAS 12036 -21 -4) is classified no dangerous and no exposure assessment was realised. Therefore, for these endpoints (long term effects), the approach for the hazard characterization of VCL4 is based on HCl.

 

Threshold values

In this section, data from all end-points are examined and analysed in order to determine for which it is relevant and possible to establish a DNEL value. The method followed is that proposed in the guidance for the implementation of REACH (Chapter R.8: Characterisation of dose (concentration) -response for human health, August 2016).

 

 1.   Oral toxicity

Not considered for workers

 

2.   Inhalation toxicity

a.   Acute exposure

Regarding the breakdown product, the threshold values chosen as relevant ones, are those of HCl released during the VCl4 process when in contact with humidity of air. These values of concern were communicated by the HCl consortium and are European OELs:

1.    Short Term Exposure Limit (STEL) (15 min): 10 ppm (15 mg/m3)  

2.    Time Weighted Average (TWA) (8h): 5 ppm (8 mg/ m3) 

 

The STEL is then considered as threshold value to cover peak exposure of HCl during the manufacturing process or uses (short exposure duration tasks as cleaning, sampling or maintenance). This value of 15 mg/m3 is chosen for acute local effect risk characterization.

 

b.   Repeated exposure

Regarding the breakdown product and the data indicates in chapter inhalation toxicity - acute exposure, the TWA of HCL (8 mg/3) is then considered as threshold value for repeated exposure during manufacture or uses .

3.   Dermal toxicity

No dose descriptor can be set for the corrosive / irritant effects (as VCl4 is classified for corrosive effects).

A qualitative approach, based on the part E of the ECHA technical guidance document on chemical safety report (part E.3.4.2) is followed. The general approach when no DNEL for an endpoint is available aims at reducing/avoiding contact with the substance. However, implementation of risk management measures (RMMs) and operational conditions (OCs) needs to be proportional to the degree of concern for the health hazard presented by the substance. The purpose of this qualitative approach is to minimize the exposure considering the level of risk related to the hazard properties of the substance (indicated by H-mention). 

According to this guidance document, VCl4 with the H-mention H314 (Causes severe skin burns and eye damage), which relates to strong corrosive effects, are allocated to the high hazard category on the basis that exposure to such corrosive substances should be strictly contained.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population