Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In accordance with REACH Annex XI, section 2, testing is technically not feasible as a consequence of the properties of the substance:

  • And In vitro tests on the mutagenic potential of VCl4 in bacteria are considered dispensable for principal considerations, since inorganic metal compounds are frequently negative in this assay due to limited capacity for uptake of metal ions (guidance on Information Requirements and Chemical Safety Assessment - Chapter R.7a: Endpoint Specific Guidance), an Ames study is not relevant for metal (guide 7a, p565).
  • VCl4, in contact of humidity, gives VO2 and HCl. The modification of the pH, due the hydrochloric acid, are known to lead to artefactual, positive results which do not reflect intrinsic mutagenicity of the test substance. Therefore, positive results from these references should be considered with extreme care and require a very thorough case-by-case validation.

And there are sufficient data on the breakdown products (vanadium dioxide n°CAS: 12036-21-4) and hydrogen chloride n°CAS: 9004-54-0 were already registered in the frame of REACH) and the breakdown substance are exempted to Registration following Annex V (Entry I).

Link to relevant study records

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Endpoint:
in vitro gene mutation study in bacteria
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
More the datawaiving based on section 2 of annex XI, the guidance 7a (guidance on Information Requirements and Chemical Safety Assessment - Chapter R.7a: Endpoint Specific Guidance) indictes that an Ames study is not relevant for metal (guide 7a, p565)
Endpoint:
in vitro gene mutation study in mammalian cells
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Annex XI - section 2. Testing is technically not feasible as a consequence of the properties of the substance (hydrolytically unstable substance and quasi-instantaneously degraded in contact with moist skin/ mucuous membranes to form VOCl2 and HCl.
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Annex XI - section 2. Testing is technically not feasible as a consequence of the properties of the substance (hydrolytically unstable substance and quasi-instantaneously degraded in contact with moist skin/ mucuous membranes to form VOCl2 and HCl.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Vanadium tetrachloride quasi-instantaneously degraded in contact with moist skin or mucuous membranes to form Vanadium dioxide and hydrogen chloride. Testing Vanadium tetrachloride for genetic toxicity is for this reason not relevant at all, but breakdown products have to be considered (classification for Vanadium dioxide and hydrogen chloride have been elaborated in the frame of REACH).

For these reasons, no classification could be set for genetic toxicity.