Aluminum antimony nickel silicon titanium vanadium oxide

Endpoint summary

Description of key information

skin:
not irritating (RA Zeolite cuboidal)
eye:
not irritating (RA Zeolite cuboidal)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

No data for skin irritation are available for the target substance Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony. Therefore, data from the analogue approach source substance Zeolite cuboidal were applied to cover the endpoint skin irritation in-vivo for the target substance:

Intact and abraded rabbit skin was exposed for 24 hours to a Zeolite, cuboidal, crystalline, synthetic, non-fibrous, whose surface was modified with 10% rare earth elements under occlusive conditions according to the guidelines of the Federal Hazardous Substance Labelling Act. Neither erythema nor edema was observed in any rabbit after 24 and 48 hours, respectively (Grace, 1976, RL2).

Eye irritation:

An in-vitro HET-CAM test was conducted with the target substance, according to the OECD draft test guideline 405 (dated 24 April 2002). Hen´s eggs with an age of nine days were used. The test material was brought onto the surface of the CAM of an egg which had been incubated at 38.5 °C and 58 % humidity for nine days. Observation time was five minutes at room temperature. Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effects on the blood vessels under the membrane. Solutions of SDS (1 %) and NaOH (0.1 N) were used as positive controls. The positive controls induced a severe irritation on the blood vessels. The test material showed no effects on the blood vessels of the CAM. The calculated mean irritation score is 0.0. In conclusion, it can be stated that under the experimental condition chosen, the test material possesses no irritation potential (Paulus 2009, RL1).

Additionally, in-vivo data for skin irritation are provided from the analogue approach source substance Zeolite cuboidal, which support the results obtained from the in-vitro data:

Zeolite, cuboidal, crystalline, synthetic, non-fibrous, whose surface was modified with approximately 10 % rare earth elements at a dose of 100 mg induced slight redness of the conjunctivae in 2 out of 6 rabbits. This slight redness in one animal lasted until observation day 3. The reversibility of these effect was not observed further since the observation period had ended at the time. As well as the other surface modified zeolites, the test substance was not considered to be ocular irritating under the conditions of the test (Grace, 1976, RL2).

Respiratory irritation:

No data are available.

Additional data for irritation 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 1 - Fluidized catalytic cracking (FCC) catalysts:

Skin: not irritating (S); Calkins and Ward 1976

Eye: not irritating (S); Calkins and Ward 1976

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

Skin: not irritating (S); WR Grace 1976; de Jouffrey 1996

Eye: not irritating (K); de Jouffrey 1996

- Source chemical 3 - Kaolin, calcined:

Skin: not irritating (K); Wnorowski 1997

- Source chemical 4 - Silicic acid, aluminium salt:

Skin: not corrosive in-vitro (Epi Derm) (K); Paulus 2010

Eye: corrosive in-vitro (HET-CAM) (K); Paulus 2010

- Source chemical 5 - Aluminium oxide:

Skin: not irritating (K); Degussa 1979

Eye: not irritating (K); Degussa 1979

- Source chemical 6: Kaolin:

Eye: not irritating (K); Merkel 1997

 

In accordance with the target substance, the available data for the source substances also provide negative results for skin and eye irritation, except for source chemical 4 (Silicic acid, aluminium salt): In a HET CAM test, Silicic acid, aluminium salt was corrosive in-vitro. This result however is considered not relevant for the target substance Aluminium silicate and titanium oxide matrix doted with vanadium, nickel, and antimony, as an additional HET CAM test provided negative results.

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.

Effect level: empty Endpoint conclusion: Adverse effect observed

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-, and eye irritation according to DSD (67/548/EEC) or CLP (1272/2008/EC).