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PBT assessment

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PBT assessment: overall result

Reference
Name:
CJ302
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

The results of Persistent, Bioaccumulative and Toxic assessment of the substance are as below. In summary, it is fulfilling 'P/vP', not 'B/vB' and not 'T' criterion. Therefore, the substance can be considered as not 'PBT' and 'vPvB'.

1. Persistence Assessment:

According to the screening criteria for persistent, a substance does not fulfil the 'P' and the 'vP' criterion if it is readily biodegrable. Based on experimental data the test substance CJ302 can be concluded to be non-readily biodegradable (OECD TG301F) and  hydrolytically stable (OECD TG111 and EU methed C.7) in the environment. In conclusion, it is regarded as persistent fulfilling the potentially 'P' and the 'vP' criterion. According to below bioaccumulation assessment, the substance is not also fulfilling the 'B' nor the 'vB' criterion. Therefore, the further information of not 'P' and not 'vP' do not be needed to provide.

2. Bioaccumulation Assessment:

When the tonnage produced or imported of the substance is below 100 t/y, normally a bioaccumulation test is not required and therefore a BCF value may not be available. According to the screening criteria for bioaccumulation, a substance does not fulfil the 'B' and the 'vB' criterion if its log Kow ≤ 4.5. The octanol-water partition coefficient for the test item is log Kow < -4.77 (OECD TG107). In conclusion, the substance is regarded as not bioaccumulative neither fulfilling the 'B' nor the 'vB' criterion.

3. Toxicity Assessment:

The substance is not harmful or toxic upon oral ingestion as demonstrated by acute oral tests. Also, no acute systemic toxicity was observed when the substance was applied to the skin or the mucosa of animals for tests on skin and eye irritation (OECD TG404 and 405), whereas the test substance was found to be skin sensitizer (OECD TG406). There is no evidence of chronic toxicity from the available oral repeated dose toxicity study is in rats (OECD TG 407). Based upon the results obtained in this study, the "no-observed-effect level" of CJ302 is 1000 mg/kg body weight for rats when administered orally by gavage. The substance is not classified as mutagenic or reprotoxic according to Regulation EC 1271/2008. But the substance does not carry out test of carcinogenic according to Regulation EC 1271/2008. No long-term studies for marine or freshwater organisms are available. Therefore, based on current knowledge, the substance does not fulfil the T criterion based on the PBT criteria according to Annex XIII of the REACH Regulation.

Aquatic toxicity studies in fish (OECD TG203), invertebrates (OECD TG202), aquatic plants (OECD TG221) and microorganisms (OECD TG209)were performed as per standard guidelines to evaluate the toxicity potential of the test substance the test substance. For all the three tropic levels (fish, invertebrates and aquatic plants) EC50/LC50 >100 mg/L. According to the screening criteria provided by ECHA, a substance must be considered to fulfil the 'T' criteria if the EC50 or LC50 of a short-term aquatic toxicity test is below 0.1 mg/L. Based on the test data for all the three trophic levels CJ302 can be classified as 'not-toxic' to aquatic organisms according to GHS and the T-criterion is not fulfilled according to the screening criteria provided by ECHA. In conclusion, the substance is regarded as not toxic fulfilling the 'T' criterion.