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Administrative data

Description of key information

In the in vitro skin corrosion test Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is shown to be not corrosive. In the in vitro skin irrisation test Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is observed to be a non-irritant. Although little cracks were observed in all three corneas, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped did not induce ocular irritation, resulting in a mean in vitro irritancy score of 3.1 after 240 minutes of treatment. Based on the results of the in vivo eye irritation study Silicic acid(H2Si2O5), barium salt(1:1), lead-doped does not have to be classified and has no obligatory labeling requirement for eye irritation.

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

An in vitro skin corrosion study according to EU B.40 and OECD 431 guidelines was performed with Silicic acid(H2Si2O5), barium salt(1:1), lead-doped. Skin corrosion is expressed as the remaining cell viability after exposure to the substance. The relative mean tissue viability obtained after the 3-minute and 1-hour treatments with Silicic acid(H2Si2O5), barium salt(1:1), lead-doped compared to the negative control tissues was 96% and 82% respectively. Because the mean relative tissue viability for Silicic acid(H2Si2O5), barium salt(1:1), lead-doped was not below 50% after 3 minutes treatment and not below 15% after 1 hour treatment Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is considered to be not corrosive.

An in vitro skin irritation study according to EU B.46 and OECD draft guidelines was performed with Silicic acid(H2Si2O5), barium salt(1:1), lead-doped. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Silicic acid(H2Si2O5), barium salt(1:1), lead-doped compared to the negative control tissues was 101%. Since the mean relative tissue viability for Silicic acid(H2Si2O5), barium salt(1:1), lead-doped was above 50% after 15 minutes treatment Silicic acid(H2Si2O5), barium salt(1:1), lead-doped is considered to be non-irritant.

An in vitro eye irritation study, BCOP, was performed according to OECD 437 guideline with Silicic acid(H2Si2O5), barium salt(1:1), lead-doped. Although little cracks were observed in all three corneas, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 3.1 after 240 minutes of treatment.

An in vivo eye irritation study with Silicic acid(H2Si2O5), barium salt(1:1), lead-doped was performed according to OECD 405, EU B.5 and EPA and JMAFF guidelines. Instillation of approximately 94 mg of Silicic acid(H2Si2O5), barium salt(1:1), lead-doped (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation grade 1 was observed for one animal and resolved within 24 hours. Irritation of the conjunctivae was observed in all animals and consisted of redness, chemosis and discharge, and had completely resolved within 72 hours. No corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.

Justification for classification or non-classification

Based on these results of the in vitro and in vivo irritation studies, Silicic acid(H2Si2O5), barium salt(1:1), lead-doped does not have to be classified for skin and eye irritation according to Directive 67/548/EC or the CLP Regulation.