N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Evidence of P or vP properties

Criteria based on Annex XIII of REACH

No data are available which would allow application of the criteria in Annex XIII of REACH. Screening criteria according to the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment, are used for the assessment.

Screening criteria

Results from a screening test on inherent biodegradability are used to evaluate persistence of the substances. The following information is available (see also Section 4.1.2 of the CSR - biodegradation):

As Naphtol-AS Pigments are highly insoluble in water, potential for biodegradation was assumed to be low. Thus instead of testing ready biodegradability which certainly would have led to negative results, inherent biodegradability was assessed in the Modified MITI Test (II) according to OECD 302 C. This test was performed on Pigment Red 210, the pigment of the category with the highest solubility in water (34 µg/L). The reliable test (without restrictions, reliability category 1) was performed compliant to GLP and fulfills validity criteria of the guideline. Biodegradation rate of the functional control aniline demonstrated the activity of the test system. No biodegradation was observed in this test (mean biodegradation rate: 0% within 28 days).

Therefore, available experimental data point out that the Naphtol-AS Pigments are not inherently biodegradable (presumably due to a very restricted bioavailability caused by their insolubility in water). This is in agreement with the desired technological function as pigments.

Conclusion on P / vP properties:

Based on screening test data on biodegradability, all members of the category are considered to be not inherently (and thus not readily) biodegradable. It is assumed that they fulfil the P criterion.

Evidence of non-B / non-vB properties

Screening criteria

-Not B / vB based on Log Kow <= 4.5: Log Pow values are available for all members of the category (see section 1.3 of the CSR). All log Pow values are smaller or equal to 3.2 and log Pow values for those pigments without determined BCF are even smaller or equal to 2.5, with values down to 0.4.

Criteria based on Annex XIII of REACH

-Not B / vB based on BCF <= 2000 L/kg: For the Naphtol-AS Pigment Red 2 the experimental log Kow value is 3.2 and thus borderline in respect to the criterion for a low bioaccumulation potential according to "column 2" in Annex IX of REACH (log Kow < 3). However, due to the Naphtol-AS Pigments in general being highly insoluble in water, according to REACH Guidance R.7c (section 7.10.3.1) bioconcentration tests according to OECD 305 (Flow-through Fish Test) would not be expected to yield any reasonable information while dietary studies are only recommended for compounds with log Kow > 6 (between 0.4 and 3.2 for the Naphtol-AS Pigments).

Thus, QSAR calculations using four different models were performed for category member Pigment Red 2. Applying the CAESAR model on bioconcentration, a BCF-value of 53 L/kg whole body wet weight could reliably be estimated (reliability category 2). This is supported by VEGA BCF Read-Across-model (BCF 29 L/kg whole body wet weight; reliable estimation, Pigment Red 2 within applicability domain), BCFBAF-model (BCF 10 L/kg whole body wet weight) and the conservative Arnot & Gobas model for the high lipid content of upper trophic level of 10.7% (worst case) and standard test fish species (5% lipid content), giving BCF-values of 169.6 and 80.0 L/kg whole body wet weight, respectively (assuming no metabolism).

As log Pow values for the other substances of the Naphtol-AS Pigments were considerably lower, these results are valid also for these pigments and even lower BCF-values can be expected due to the lower log Pow of these substances. This assumption is supported by not assignable QSAR results (reliability category 4) for a further of 4 pigments (Environment Canada, 2008 and 2009; Pigments Orange 38, Red 5, Red 146, and Red 187; BCF ≤21.4 L/kg for all of these pigments, using three different models).

Evidence of B or vB properties

No evidence.

Conclusion on B / vB properties: not B/vB

Concluding from the screening criterion log Kow, all substances of the Naphtol-AS Pigment category are considered to be not bioaccumulative (not B, not vB).

The same conclusion results from application of the criteria of Annex XIII of REACH on the reliable (reliability category 2) BCF-value determined by QSAR (supported by the results of three further QSAR-models within this same study) for the only pigment of the category with experimental log Kow > 3 (3.2).

Evidence of non-T properties

Criteria based on Annex XIII of REACH

-Not T based on criteria laid down in Annex XIII of REACH:

·   EC10 / NOEC >= 0.01 mg/L for marine / freshwater organisms (long-term toxicity):Members of the category were tested for aquatic toxicity in short-term and long-term toxicity tests with organisms from the various trophic levels. Data include chronic tests on Daphnia magna (pigments Red 22 and Red 112) as well as growth inhibition tests on algae (pigments Red 2, Red 22, Red 112 and Red 210). No toxic effects were observed either for saturated solutions prepared at a nominal limit concentration of 1 mg/L or for pigment dispersions of Pigment Red 22 of 30 mg/L (Daphnia manga reproduction test) and 3.2 mg/L (Algae growth inhibition test). These (nominal) concentrations are far above the range of water solubilities determined for these pigments (between 5.4 and 34 µg/L).

·   Substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC (or the DSD) or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 (or CLP Regulation) (see also section "3. Classification and labelling"):None of the substances of this category has to be classified as carcinogenic, mutagenic or toxic to reproduction.

·   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 category 1 or 2) according to Regulation EC No 1272/2008: For none of the substances of this category there is any evidence for toxicity after chronic exposure.

Other evidence of non-T properties

In Chapter R.11 of Guidance on REACH a screening criterion for T is given. The T criterion is presumably fulfilled if EC50 or LC50 from short-term aquatic toxicity tests (with algae, daphnia or fish) is below 0.1 mg/L and definitely fulfilled if below 0.01 mg/L.

Short-term tests on fish with Pigments Red 22, Red 146 and Red 184 as well as daphnia with Pigments Red 2, Red 22 and Red 146 did not reveal any signs of toxicity when substances were tested at nominal concentrations up to 100 mg/L.

Evidence of T properties

Remark: No evidence.

Conclusion on T properties: not T

In summary, from the experimental datas it can be concluded that the members of the Naphtol-AS Pigment category are not toxic to aquatic organisms when exposed up to the limit of solubility (nominal concentrations tested were high above the water solubility and were up to 200 mg/L). Furthermore, these substances have no CMR properties and are not toxic after chronic exposure, i. e. the T criterion is not fulfilled

 

8.1.2. Summary and overall conclusions on PBT or vPvB properties

Overall conclusion:

Based on the assessment described in the subsections above the submission substance is not a PBT / vPvB substance.

Justification:

Based on evaluation of the data described in the endpoint it is concluded here that the members of the Naphtol-AS Pigment category

·  are not inherently (and thus also not readily) biodegradable and are considered to fulfil the P criterion

·  are not fulfilling the B (or vB) criterion

·  and are not fulfilling the T criterion

and therefore are evaluated to be neither PBT nor vPvB substances.

Overall conclusion:

Based on the assessment described the submission substances of the category of Naphtol-AS Pigments are not considered to be PBT /vPvB.