4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide

PBT assessment

PBT assessment: overall result

Reference

Name:

Disperse Red 092

Type of composition:

legal entity composition of the substance

State / form:

solid: bulk

Reference substance:

Disperse Red 092

PBT status:

the substance is not PBT / vPvB

Justification:

Persistence Assessment:

In a key study to assess the ready biodegradability of FAT 40444/B, the test item attained 0 % biodegradation after 28 days and therefore cannot be considered to be readily biodegradable. In a supporting study, the BOD5/COD ratio was equal to 0.13, indicating that the substance is not readily biodegradable. Hence, the substance may persist in the environment.

 

Bioaccumulation Assessment:

The partition coefficient of the test substance FAT 40444 was determined to be 1.88 (log Kow) in a study conducted according to OECD Guideline 107, OECD Guideline 117 and EU Method A.8. According to the screening criteria for bioaccumulation (B for bio accumulative, vB for very bio accumulative) given in the technical guidance provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance does not fulfil the B and the vB criterion if its log Kow ≤ 4.5. Hence, the substance is regarded as not bio accumulative neither fulfilling the B nor the vB criterion.

 

Toxicity Assessment:

No long-term studies for marine or freshwater organisms are available. The aquatic toxicity potential of FAT 40444/B was evaluated at three trophic levels of fish, invertebrates and plants. The 96 hour LC50 to fish was determined to be >300 mg/L. In the study with Daphnia magna, 48 hour EC50 value was determined to be greater than 0.29 mg/L. This study showed that there were no toxic effects at saturation. Similarly, in the study with freshwater plant Lemna minor, 7 day EC50 and NOEC calculated using average specific growth rate based on frond number was determined to be >0.54 and 0.54 mg/l (saturation concentration), respectively. As the data indicate, no toxicity is observed at the saturation concentration in any of the studies, FAT 40444/B is considered to be not toxic to aquatic ecosystems. Also, the substance does not warrant classification for CMR or STOT RE categories. Hence, it was concluded to not fulfil the toxicity criteria.

 

Conclusion: 

Disperse Red 092 may persist in the environment as it is found to be not readily biodegradable. However, it does not fulfil the criteria for being bioaccumulative or very bioaccumulative as well as for being a toxicant. Hence, it is considered to be not PBT/vPvB.