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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The submission substance is inherently biodegradable and is not expected to be persistent (P) or very persistent (vP).

The submission substance is not bioaccumulative (B) or very bioaccumulative (vB) based on calculated bioconcentration factor (BCF) or bioaccumulation factor (BAF) values. 

The low water solubility and high partition coefficient of the submission substance makes it very difficult to conduct an aqueous BCF study. Support data were mainly provided by the calculated bioconcentration factor (BCF) value of 0.893 and the calculated BAF value of 0.893 to 0.9475 for the submission substance using the U. S. Environmental Protection Agency EPI Suite model (v 4.00) (US EPA, 2009d). A further mitigating factor is the very high log Kow value (>10) which limits uptake across membranes due to bioavailability/membrane permeation constants. For the submission substance, the log Kow partition coefficient was determined experimentally by the HPLC method to be greater than 10 (Huntingdon Life Sciences, 2010a) while the calculated log Kow values of 10.03, 16.89 and 23.74 for the components were estimated using the EPI Suite model (U. S. EPA, 2009f). This data support the fact that the BCF value for the submission substance is well below the 2000 L/kg which is the criterion for not being considered bioaccumulative (B) and is well below the 5000 L/kg which is the criterion for not being considered very bioaccumulative (vB). 

 

The submission substance naphthalene reaction products with tetradecene, does not cause acute or chronic toxicity to aquatic organisms on all three trophic levels (fish, aquatic invertebrates, algae) in the range of water solubility of the substance. Hence, the submission substance does not fulfill the toxicity (T) criterion for aquatic organisms. 

The submission substance does not fulfill the toxicity (T) criterion for human health based on the following evidence. 

Carcinogenicity. The submission substances is not classifiable as to human carcinogenicity based on a lack of available carcinogenicity data in experimental animals and humans. However, based on available mutagenicity, genotoxicity and repeated dose studies, the submission substance is not considered likely to be carcinogenic to humans. In vitroandin vivomutagenicity and genotoxicity tests for the submission substance and structural analogues were negative. Additionally, there was no evidence of hyperplasia in repeated dose toxicity studies. There were no relevant human studies identified. In summary, there are no data to suggest that the submission substance is potentially carcinogenic to humans.

Mutagenicity. Substances known to be mutagenic to man (Category 1) or substances which should be regarded as if they are mutagenic to man (Category 2) based on sufficient animal studies or other relevant information also defines the criterion for T. For example, results from reliable and robustin vitrobacterial and mammalian genetox assays and anin vivochromosome aberration assay on the submission substance, were negative. In addition, a read-acrossin vitrogene mutation assay was negative. Overall, the available mutagenicity data indicates that the submission substances is not likely to be mutagenic (CSR Section 5.7) and does not meet the criterion for T based on mutagenicity.

Repro/Developmental Tox. The T criterion includes substances known to impair fertility in humans or cause developmental toxicity in humans (Category 1), substances regarded as if they impair fertility in humans or cause developmental toxicity to humans (Category 2), or substances which cause concern for human fertility or for humans owing to possible developmental toxic effects (Category 3). In each case appropriate animal or other relevant studies are needed to clearly show or support toxic effects. A reproductive and developmental toxicity test on the submission substance, showed no effect on reproductive or developmental parameters. There were no relevant human studies identified. Data on all other toxicological endpoints support low toxicological activity, including an absence of effects on reproductive tissues in repeated dose toxicity studies. Collectively, these data suggest that the submission substance is not likely to be a reproductive toxin (see CSR section 5.9 for more detail).

In conclusion, the submission substance is not PBT and not vPvB.