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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Acid Orange 067
Type of composition:
legal entity composition of the substance
Reference substance:
Acid Orange 067
PBT status:
the substance is not PBT / vPvB
Justification:

PERSISTENCE

The substance is considered as neither readily nor inherently biodegradable in standard tests for biodegradability. Furthermore, abiotic degradation by hydrolysis is excluded estimated to be negligible degradation pathway due to the chemical structure and functional groups presents.

Thus, the substance should be considered as persistent.

 

BIOACCUMULATION

The substance is expected to possess a low potential for bioaccumulation, based on the screening evaluation taken into account the experimental log Pow (i.e. 1.03). Furthermore, it is estimated be not bioavailable, based on the Lipinski Rule Oasis tool, implemented into the QSAR Toolbox 4.1.

Thus, B-criterion is not met.

 

TOXICITY

Aquatic long-term toxicity data are not available for Acid Orange 067, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data. Short-term toxicity studies show that the substance does not cause adverse effects on aquatic organisms and it does not meet the criteria to be classified hazardous for aquatic life. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008 and there are no other evidence of chronic toxicity, as identified by the classifications specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008.

Although the substance is expected to not meet the criteria to be considered T, a definitive conclusion about the T-criterion cannot be reached.