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PBT assessment

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PBT assessment: overall result

Reference
Name:
Glyoxal-urea copolymer
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Related composition:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
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:

Persistence assessment:

The substance is not readily biodegradable (OECD 301F, GLP study).

There are no appropriate half-life data available for drawing conclusions as to the P / vP properties of the assessed substance.

Conclusion on P / vP properties: No conclusion can be reached for Persistence (P).

Bioaccumulation assessment:

The log octanol-water partition coefficient (Log Kow) was estimated for the main constituents of the substance since it is an UVCB the study is technically not feasible. Based on the worst case assumption the substance was determined to have a log kow of -3.41 (EPI-Suite, KOWWIN v1.68).

Conclusion on B / vB properties: The substance is not fulfilling the criteria for Bioaccumulation (B).

Toxicity assessment:

There is no long-term toxicity studies available with fish and crustacean.

Toxicity to aquatic algae: NOEC (72h) = 522.6 mg/L (basis for effect: growth rate) (OECD 201, GLP study).

Moreover, regarding the acute aquatic toxicity:

Short-term toxicity to fish: LC50 (96h) = 652.77 mg/L (based on mortality) (OECD 202, GLP study).

Short-term toxicity to aquatic invertebrates: EC50 (48h) = 466.77 mg/L (based on mobility) (OECD 202, GLP study).

Toxicity to aquatic algae: EC50 (72h) > 1046.5 mg/L (based on growth rate) (OECD 201, GLP study).

The substance is not classified as carcinogenic or toxic for reproduction.

The substance is not classified as STOT RE.

Based on the positive Ames tests, the substance is classified as Mutagen Category 2 in accordance with CLP Regulation (EC) no 1272/2008.

Conclusion on T properties: The substance is determined to be T