Registration Dossier
Registration Dossier
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EC number: 248-882-8 | CAS number: 28173-59-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
1. Persistence Assessment:
Disperse Red 302:1 was found to be biodegradable at 21 % (primary biodegradation) after an incubation time of 28 days in the modified MITI (II) test conducted according to OECD Guideline 302C. In conclusion, the substance should be regarded as only persistent (P) in the environment and not very persistent (vP) in the environment as it is found to undergo primary biodegradation.
2. Bioaccumulation Assessment:
The partition coefficient n-octanol/water of Disperse Red 302:1 at 20 °C was calculated from the individual solubility in water and n-octanol and was determined to: log Pow = 5.16. However, several experimental fish bioaccumulation tests for disperse anthraquinone dyes, performed according to test methods specified by the Japanese Ministry of International Trade and Industry (MITI), reported log bioaccumulation factor (BCF) of <0.7 (BCF <5), expressed on the basis of wet body weight of the fishes (Anliker et al. 1981; Anliker and Moser 1987). Disperse anthraquinone dyes are also known to have large cross sectional diameters which are associated with slow bioaccumulation. Taking this information into account, the substance is regarded as not bioaccumulative neither fulfilling the B nor the vB criterion.
3. Toxicity Assessment:
No long-term studies for marine or freshwater organisms are available. However, the substance was tested with species across trophic levels, that included fish, daphnia and Lemna. Based on the available data from from these studies, Disperse Red 302:1 is not toxic to aquatic species (EC50 >100 mg/l). Further, the substance is not classified as carcinogenic, mutagenic or reprotoxic according to Regulation (EC) No. 1271/2008. Therefore, based on current knowledge, the substance does not fulfil the T criterion based on the PBT criteria according to Annex XIII of the REACH Regulation.
Based on the above discussion, Disperse Red 302:1 can be potentially persistent (P), however, not considered to fulfil bioaccumulation (neither B nor vB) as well as toxicity (T) criterion, hence it is considered to be neither PBT nor vPvB.
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