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Classification & Labelling & PBT assessment

PBT assessment

Administrative data

Assessed Substance

Assessed substance:
substance itself

Results of detailed PBT / vPvB assessment

Persistence

Evidence of non-P / non-vP properties
Screening criteria
Criteria based on Annex XIII of REACH
Other evidence of non-P / non-vP properties
Remark:
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.
Evidence of P or vP properties
Remark:
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.

The following information is available:
- Pigment Yellow 13 was tested for ready biodegradability in a modified MITI-test (OECD 301C, RL 2; VKI, 1995).
- Pigment Yellow 170 was tested for ready biodegradability in a modified Sturm-test (OECD 301B, RL 1, Safepharm Laboratories, 1994).
- Furthermore, information from incompletely documented MITI tests (all OECD 301C, RL 4) for Pigment Yellow 12, 14, and 83 are available (National Institute of Technology and Evaluation, Japan, 1980, 1996 and 2002, respectively).

All experimental data point out that the diarylide yellow pigments are poorly biodegradable. This is in agreement with the desired technological function as pigments.
Conclusion
Remark:
Based on the available data of the members of the category the substance is considered to be not readily biodegradable. It is assumed that it fulfils the P criterion

Bioaccumulation

Evidence of non-B / non-vB properties
Screening criteria
Not B and not vB based on: Log Kow ≤ 4.5
Remark:
Diarylide Yellow Pigments are very poorly soluble in water and in n-octanol. Thus, the OECD methods for determination of log Pow are not applicable to most substances of this group. Therefore, the ETAD (Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturer) developed a method for the determination of the log Pow of pigments (method agreed upon “Analytical Experts Meeting” of ETAD (Basel) on 12 January 2005; briefly summarized: water and n-octanol solubility of the pigments are determined separately and the log Pow is calculated as the logarithmised ratio of the obtained solubilities).

Log Pow values are available for all members of the category. All log Pow values are below 2.2, most are below 2.

The lowest log Pow was obtained for Pigment Yellow 83 (log Pow = 0.02),
Criteria based on Annex XIII of REACH
Not B and not vB based on: BCF ≤ 2,000 L/kg
Remark:
For pigments of the Diarylide Yellow Pigment category, two experimental tests for bioconcentration according to
OECD 305 are available:

Pigment Yellow 13 was testet in a reliable study (reliability category 1) on Cyprinus carpio for bioconcentration in a
flow through system with a total uptake duration of 28 days. As the measured concentrations of the test substance in
test fish were less than the minimum determination limit of the test substance in fish (0.58 μg/g) for all five
measurements during the 28 day period (day 5, 8, 14, 21, 28), only the upper limit for possible bioconcentration as
determined by the ratio of the mean measured concentration in water at steady state (0.0936 mg/L) and the limit of
determination in fish (0.58 mg/kg) could be calculated: BCF ≤ 6.2 (= 0.58 mg/kg / 0.0936 mg/kg).

Also for Pigment Yellow 14 an experimental determination of the BCF according to OECD 305 is available.
However, as the original study is in Japanese only basic data (experimental details, details on test substance and
purity and basic experimental results) are available. Therfore the study is rated as not assignable (reliability category
4). This study is however supporting the results with Pigment Yellow 13, as also with this study the BCF was
determined by the ratio of the detection limit in fish and the test substance concentration in water. As two
concentrations in water, differing by a factor of ten, had been tested (6 weeks test period), two upper bound
estimates for the BCF are resulting: BCF ≤ 0.5-0,6 and BCF ≤4.9, respectively (measuremens week 2, 3, 4 and 6 in
duplicate for each test concentration).

Both studies conclusively confirm that the substances of the Diarylide Yellow Pigment category have no potential
for bioaccumulation
Conclusion
Conclusion on B / vB properties:
not B/vB
Remark:
Concluding from experimental test results according to OECD 305 for two pigments and the screening criteria as detailed above, the substances of the Diarylide Yellow Pigment category are clearly not bioaccumulative (not B, not vB).

Toxicity

Evidence of non-T properties
Criteria based on Annex XIII of REACH
Not T based on:
EC10 or 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 two long-term toxicity tests (with Pigment Yellow 13 and 83) with Daphnia magna, which yielded NOAECs of 1 mg/L and 10 mg/L, respectively. Short-term tests with Pigment Yellow 12, 13, 83 and 170 did not reveal signs of toxicity when substances were tested at a limit concentration of 0.1 mg/L or in nominal concentrations up to 100 mg/L.

In summary, there was no toxicity noted in any of these tests when the aquatic organisms were exposed up to the limit of solubility (nominal concentrations tested were high above the water solubility and were up to 100 mg/L).
and 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 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:
None of the substances of this category has to be classified as carcinogenic, mutagenic or toxic to reproduction and
there is no evidence for toxicity after chronic exposure
Evidence of T properties
Conclusion
Conclusion on T properties:
not T
Remark:
In summary, from the experimental data it can be concluded that the members of the Diarylide Yellow 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 100 mg/L). Furthermore, these substances have no CMR properties and are not toxic after chronic exposure, i.e. the T criterion is not fulfilled.