Reaction mass of Dimethyl [3-[(hydroxymethyl) amino]-3-oxopropyl] phosphonate and Dimethyl (3-amino-3-oxopropyl)phosphonate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

1. Persistence Assessment

The substance is not readily or inherently biodegradable according to two valid supporting biodegradation tests. Data on biodegradation in the sediment and soil compartments are lacking. The test item hence should be considered as not biodegradable. The substance is hydrolytically stable under neutral and acidic environmental conditions but shows a tendency for less stability in basic environments. 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.

In conclusion, the substance should be regarded as persistent (P) in the environment or very persistent (vP) in the environment.

2. Bioaccumulation Assessment

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 fulfill the B and the vB criterion if its log Kow ≤4.5. The octanol-water partition coefficient for the test item is log Kow <-1.68. This value is much below the threshold value of log Kow ≤4.5. In conclusion, the substance is regarded as not bioaccumulative neither fulfilling the B nor the vB criterion.

3. Toxicity Assessment

The substance is neither classified as carcinogenic, mutagenic or toxic for reproduction and there is no other evidence of chronic toxicity from the available 28-day repeated dose mammalian toxicity test. No sub-chronic or chronic repeated dose toxicity studies are available. No long-term studies for marine or freshwater organisms are available. Therefore, based on current knowledge, the substance does not fulfill the T criterion based on the PBT criteria according to Annex XIII of the REACH Regulation.

According to the screening criteria provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance has to be considered to fulfill the criteria for toxicity (T for toxicity) if the EC50 or LC50 of a short-term aquatic toxicity test is below 0.1 mg/L. For the substance under consideration, the following EC50/L50 values were obtained:

• Short term toxicity to fish: LC50: >1000 mg/L,

• Short term toxicity to aquatic invertebrates: EC50: >100 mg/L,

• Short term toxicity to aquatic algae: EC50: >100 mg/L.

These values are much above the threshold value of 0.1 mg/L and do therefore not indicate that the substance fulfils the T criterion.

In conclusion, the available data on toxicology and ecotoxicology give no evidence of significant toxicity and it is regarded as unlikely that DMPPA_701-402-5 fulfills the T criterion on the basis of the available data.

4. Summary and overall Conclusions on PBT or vPvB Properties

The substance should be considered as persistent in the environment. It has no potential for bioaccumulation. The available toxicological and ecotoxicological data do not give evidence of significant toxic effects of the substance. The test item is fulfilling the P or even the vP criterion, but not the B or vB and T criteria according to Annex XIII of the REACH Regulation. The substance is not a PBT or vPvB substance according to the REACH Regulation.