Strontium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)azo]-2- naphthoate 5/2 hydrate

PBT assessment

PBT assessment: overall result

Reference

Name:

Strontium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)azo]-2-naphthoate 5/2hydrate

Type of composition:

boundary composition of the substance

Reference substance:

Strontium 3-hydroxy-4-[(1-sulfonato-2-naphthyl)azo]-2-naphthoate 5/2hydrate

PBT status:

the substance is not PBT / vPvB

Justification:

The substance was found not to be readily biodegradable and hydroylsis testing was not feasible on the basis of poor water solubility. In the absence of any data it must be assumed the substance may posseses P or vP properties however additional test data would be required to confirm.

The partition coefficient test was not feasible on the basis of poor solubility therefore a log Kow could not be determined.  Literature data are available on very similar compounds whic confirm the substance is not bioaccumulating. Please refer to the full Bioaccumulation waiver report attached under section 13.2 (Other assessment reports) for a detailed justification.

Long term toxicity data are not available for all trophic levels however during the long term daphnia study no toxicity was seen. No toxcity was seen at any trophic level during acute aquatic toxicity testing. The substance is also considered non-toxic as there is no other data to suggest otherwise. There are no carcinogencity data available. For mutagenic effects all three in-vitro studies were concluded as non-mutagenic. Therefore we can confirm that R507-2 does not cause genetic toxicity. In the reproductive toxicity screening study no reproductive effects were seen and no development effects were seen in the absence of possible toxic effects seen in maternal animals. Also no toxicity was seen in the 28 day repeated dose oral toxicity study.

Based on the following information the substance cannot be considered a PBT substance.