Registration Dossier

Administrative data

Description of key information

EYE IRRITATION:
Inconclusive (Similar to OECD 405), Auletta (1985)

However, the study does not need to be conduceted beacuease the subtance is sponeously flammable in iar at room temeprature.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key study, Auletta (1985), the eye irritation potential of the test material to the New Zealand White rabbit was investigated in a study conducted using methodology similar to the standardised guideline OECD 405. Due to the limitations of the methodology of the study, a reliability score of 4 was assigned in accordance with the criteria for assessing data quality as described in Klimisch et al. (1997).

The undiluted test material was administered at a dose of 0.1 mL to the conjunctival sac of the eye in the first of six animals. Upon administration of the test material, any material on the eyelids or hair around the eyes ignited. The fire was extinguished with pressure from paper towels. Based on this, the test material was considered to be too reactive and no further animals were dosed. The single female rabbit administered with the test material was observed for 72 hours for signs of irritation.

Mild, transient ocular irritation consisting primarily of conjunctival chemosis and discharge with the most severe effects noted at 24 hours was observed. No corneal changes were seen.

Periorbital erythema and chemosis apparently resulting from the ignition of the periorbital hair at the time of dosing were noted. This was still evident after 72 hours.

The irritancy potential of the test material cannot be concluded from this study due to the use of a single animal. The study was terminated after administration to the first animal due to the pyrophoric properties of the substance.

Justification for classification or non-classification

The available information is not sufficient to draw conclusions on the skin and eye irritation/corrosion potential of the substance in accordance with Annex I of the regulation EC 1272/2008 (CLP) but no further study is required because the substance is spontaeously flammable in air at room temperature.