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Administrative data

Description of key information

Summary of irritation data

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation / Corrosion

The results of an in vitro skin irritation test in the EpiSkinTM model with Reactive Orange F08-0314 indicated that the test item is non-irritant. In addition, the test substance did not cause any skin irritation in the acute dermal toxicity study up to the limit dose (2000 mg/kg bw).

Eye irritation

The results of the in vitro eye irritation study in the isolated chicken eyes model with Reactive Orange F08-0314 indicated that the test item was not irritating.

An acute eye irritation study with Reactive Orange F08-0314 was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002). The test item, applied to rabbit eye mucosa, caused conjunctival irritant effects at one hour, which were reduced at 24 hours after application. There were no corneal irritation effects observed at any timepoint; all conjunctival irritation effects were completely reversed after the 48 hours observation period. Discolouration of the cornea was fully reversible within 2 weeks. Some discolouration of the conjuctivae remained at the observation period of 3 weeks, but this is not considered as a classifiable effect under the CLP Regulation.

Respiratory irritation

Respiratory irritation was not assessed; however no effects on the animals were noted in any associated studies.

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).