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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Methylphosphonic acid, compound with amidinourea (1:1)
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence assessment:

Screening criteria:

The substance is not readily, but slightly inherent biodegradable according to a valid supporting inherent biodegradation test.

Data on the biodegradation in the sediment and soil compartments are not available. The test item hence should be considered as not biodegradable. The substance is hydrolytically stable under neutral and acidic environmental condition but shows a tendency for less stability in strong alkaline settings. Photodegradation in air is not a relevant degradation process for this substance since the test item has negligible vapour pressure and atmospheric release in form of fumes or aerosols is unlikely with regard to the identified use patterns. There is no information available about photodegradation of the substance in sediment or soil.

Conclusion of Persistence assessment:

The substance should be considered as persistent in the environment, but not as very persistent (vP) in the environment.

 

Bioaccumulation assessment:

Screening criteria:

According to the screening criteria for bioaccumulation (B for bioaccumulative, vB for very bioaccumulative) given in the technical guidance provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance does not fulfil the B and the vB criterion if its log Kow ≤ 4.5. The estimated octanol-water partition coefficient for the substance is log Kow < -2.7, which is far below the B and the vB criterion.

Conclusion of bioaccumulation assessment:

The substance is not considered to be bioaccumulative,neither fulfilling the B nor the vB criterion.

 

Toxicity assessment

Criteria based on Annex XIII of REACH:

- Not T based on the following criteria:

 EC50 / LC50  >= 0.1 mg/L for marine / freshwater organisms (short-term toxicity),
EC10 / NOEC >= 0.01 mg/L for marine / freshwater organisms (long-term toxicity):

All short-term aquatic toxicity values, with the exemption of the 72h-EC50 for freshwater algae (43.1 mg/L), are > 100 mg/L.

The 72h-EC10 value for algae is 13.5 mg/L, the 72h(96h)-NOEC = 3.2 mg/L.

The substance is not classified as carcinogenic (cat 1 or 2), mutagenic (cat 1 or 2), or toxic for reproduction (cat 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (cat 1A or 1B), germ cell mutagenic (cat 1A or 1B), or toxic for reproduction (cat 1A, 1B or 2) according to Regulation EC No 1272/2008.

  No other evidence of chronic toxicity, as identified by the classifications T, R48, or Xn, R48 according to Directive 67/548/EEC) or specific target organ toxicity after repeated exposure (STOT RE cat 1 or 2) according to Regulation EC No 1272/2008.

Conclusion of Toxicity assessment:

The substance is not considered to be toxic to the aquatic environment.

The substance shows no mutagenic toxicity with or without metabolic activation in vitro.

The substance shows no toxicity after repeated exposure (NOAEL = 1000 mg/kg bw/kg).

Likely routes of exposure:

No emission characterization is required since the substance is not a PBT or vPvB substance.