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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A local lymph node assay was performed with the test material Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony, according to OECD guideline 429 (Vogel 2010, RL1). Three groups each of four female mice were treated with different concentrations of the test material by topical application at the dorsum of each ear lobe (left and right) on three consecutive days.A control group of four mice was treated with the vehicle only. Five days after the first topical application, the mice were intravenously injected into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight.The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a ß-scintillation counter. All treated animals survived the scheduled study period and no signs of toxicity were observed. In this study Stimulation Indices of 1.11, 1.17, and 0.96 were determined with the test item at concentrations of 5, 10, and 25% in propylene glycol.The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.

 

Additional data for sensitization are available for the following source substances which serve as potential data sources for the analogue approach of Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony:

- Source chemical 2 - Zeolite, cuboidal, crystalline, synthetic, non-fibrous:

not skin sensitizing (Buehler) (K); Young and Doyle 1973

- Source chemical 4 - Silicic acid, aluminium salt:

not skin sensitizing (LLNA) (K); Vogel and Reichenbach 2010

- Source chemical 5 - Aluminium oxide:

not skin sensitizing (guinea pig) (K); Central Instritute for Nutrition and Food Research 1979

In accordance with the target substance, the available data for the source substances also provide negative results for skin sensitization.

The respective references for the source substance data can be found in the data matrix of the justification for the analogue approach, which can be found either in the CSR or as attachment in Iuclid section 13.

 


Migrated from Short description of key information:
skin: not sensitizing

Respiratory sensitisation

Endpoint conclusion
Additional information:

There are no data available for respiratory sensitization.


Migrated from Short description of key information:
no data

Justification for classification or non-classification

Based on the results obtained, Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony does not fulfill the criteria to be classified for skin sensitization according to DSD (67/548/EEC) or CLP (1272/2008/EC).