N-[[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]carbamoyl]-2,6-difluorobenzamide

PBT assessment

PBT assessment: overall result

Reference

Name:

Noviflumuron

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Noviflumuron

PBT status:

the substance is PBT / vPvB

Justification:

P CRITERIA

The substance is not readily biodegradable (0.2 to 4 % after 29 days in an OECD 301 B Test) and as such the substance is considered to fulfil the P-screening criteria. In addition, degradation under aerobic conditions was also investigated in three soils (two silt loams and one silty clay loam) according to US EPA 162-1 and 163-1 Guideline. Two metabolites were observed (amine at ca. 13.9 % and urea at ca.9 %), however no degradation rates were calculated. The half-life of the parent substance ranged from 267 to 315 days (at 25 °C) and 755 to 891 days (at 12 °C). Therefore the substance can be considered to fulfil the vP-criterion according to Annex XIII (vP fulfilled if half-life in soil is > 180 days).

 

B CRITERIA

Screening Data

The log Kow was determined to be 4.94, which is above the screening criteria indicated in Annex XIII (B fulfilled with log Kow of ≥ 4.5) and as such the substance fulfils the screening criteria.

Other Supporting Information

No measured data is available, but EPISUITE (BCFBAF v3.01) estimated a BCF of 857.1 L/kg wwt (regression method) and a BCF of 2129 L/kg wwt (Arnot Gobas method).

Usually the regression method is the most common, however as there is a contradiction between the results, the value based on the Arnot Gobas method would fulfil the B-criterion (>2000); therefore in the absence of any experimental data the substance has to be considered as fulfilling the B-criterion (log kow > 4.5 and BCF > 2000). Further information would be required to show that the substance is not bioaccumulative.

 

T CRITERIA

Short Term Aquatic Toxicity

The lowest L/EC50s value was taken from a 48 h study conducted in Daphnia magna: 311 ng/L (3.11E-04 mg/L). This value shows that the T-screening criteria (T screening criteria met with L/EC50 <0.1 mg/L) as outlined in the ‘Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.11: PBT Assessment’ is met.

Long Term Aquatic Toxicity

In addition, the lowest NOEC available is from a chronic Daphnia test: 1.8E-05 mg/L (reproduction), confirming that the substance does fulfil the T-screening criterion included in Annex XIII (T fulfilled if NOEC is < 0.01 mg/L).

Therefore it can be concluded that the substance does fulfil the T-criterion.

Human Health

The substance is classified as carcinogenic Category 2 and toxic for reproduction Category 2.

With regard to the Human Health classification it should be noted that the substance is not classified as carcinogenic (category 1A or 1B) or mutagenic (category 1A or 1B), and there is no other evidence of chronic toxicity, as identified by the classifications: STOT RE category 1 or 2 according to Directive 1272/2008.

Conclusion

Based on the available aquatic toxicity (short and long term) information and human health toxicological information, it can be concluded that the substance does fulfil the T-criterion.

Likely routes of exposure:

The substance is manufactured under conditions expected to minimise exposure to workers and the environment and so there are no likely routes of exposure. Exposure to the general public is not anticipated to occur as there are minimal releases from the manufacturing process and the substance is exported from the EU following manufacture