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PBT assessment

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PBT assessment: overall result

Reference
Name:
Disperse Blue 359
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:

The relative biodegradation values calculated from the measurements performed during the Sturm test period revealed no significant biodegradation of Disperse Blue 359. It was reasoned that Disperse Blue 359 was not biodegradable. Ready biodegradation is listed in Section 3.1 of ANNEX XIII of REACH, indicating Disperse Blue 359 is persistent.

The HPLC method using soil-adsorption-reference was applied for the determination of the adsorption coefficient (Koc) of Disperse Blue 359. The Koc and logKoc values of the test item at pH 7 were 4.2x103 and 3.62 respectively. Not B and not vB because Log Kow < 4.5

No reproductive, parental or developmental toxicity was observed up to the highest dose level tested (1000 mg/kg). Test item deemed to be non-cytotoxic and not mutagenic in the TK mutation system under the experimental conditions carried out.

Based on the results of the in vitro gene mutation study it was concluded that Disperse Blue 359 is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.

It is concluded that the from the in vitro micronucleus assay that the testing was valid and that Disperse Blue 359 is not clastogenic or aneugenic in human lymphocytes under the experimental conditions described.

The oral LD50 value of Disperse Blue 359 in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Therefore, test item is not toxic.