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PBT assessment

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PBT assessment: overall result

Reference
Name:
1-imino-1H-isoindol-3-amine
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence assessment

The substance has been evaluated in a ready biodegradation study according to OECD 301B (CO2 evolution). The degradation started quickly but reached a plateau after 11 days. Up to 55 % biodegradation within 28 days was observed. However, since the pass levels were not reached within the 10-day window, the substance is regarded as 'not readily biodegradable'.

Also abiotic degradation was assessed in an hydrolysis experiment according to OECD 111. At pH 4, pH 7 and pH 9 hydrolysis was observed. The half-life at pH 4 is determined to be 0.9 days at 20°C, at pH 7 the half-life at 20°C is 3.9 days and at pH 9 a half-life of 4.4 days was observed at 20°C.

Based on the available information on biodegradation and hydrolysis it can be assumed that the substance is not P.

Bioaccumulation assessment

For this substance only information on the partition coefficient is available. The partition coefficient was assessed according to OECD 107, shake flask method. The log Pow value is 0.62, which is very low. Based on this information, the log Kow is well below the screening cut-off log Kow = 4.5.

Additionally, a QSAR model (BCFBAF v3.01, available in EpiSuite) has been ran to check the bio-accumulation potential. The calculated BCF using the measured log Kow value of 0.62 was 3.162 L/kg. This value is well below 2000 L/kg, the cut-off value for bio-accumulation.`

We hence conclude that the substance is most likely not B.

Toxicity assessment

The test substance was found to be mutagenic in the in vitro mammalian cell gene mutation assay (Thymidine kinase locus) in mouse lymphoma L5178Y cells. Further testing is required to assess the genetic toxicity potential of this substance and to conclude on its CMR properties.

Based on the available ecotoxicological information and awaiting further testing to assess the genotox properties, the substance should not be considered T.