Registration Dossier
Registration Dossier
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EC number: 205-126-1 | CAS number: 134-03-2
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Sodium ascorbate
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Sodium ascorbate
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Conclusion on Persistance: not vP and not P
In a Ready Biodegradability Test according to OECD Guideline 301 A and EU Method C.A.4, the test item reached a biodegradation rate of > 99% % (DOC removal) after 28 days. Moreover, the pass level for ready biodegradability (70% removal of DOC in a 10-day window within a 28-day period) was reached. Therefore, the test item is regarded to be in the 10-d-window and after 28 days readily biodegradable (see IUCLID section 5.2.1). The determined DOC removal of > 99% is much higher than the threshold value for non-persistence (not vB, not B) of >= 70% (regarding OECD Guideline 301 A) as cited in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part C: PBT/vPvB assessment (Version 3.0, June 2017). Therefore, the substance is not considered to be persistent (P) or very persistent (vP).
Conclusion on Bioaccumulation: not vB and not B
The partition coefficient, log Pow, of the test item was calculated from the individual solubilities in n-octanol and in water to be log Pow < -4.2 at 21.9 °C. The pH in the aqueous phase was 6.6. (see IUCLID section 4.7). This result is far below the threshold value for bioaccumulative potential of log Pow > 4.5 as cited in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part C: PBT/vPvB assessment (Version 3.0, June 2017). Thus, the substance is not considered to be very bioaccumulative (vB) or bioaccumulative (B).
Conclusion on Toxicity: not T
The criterion for toxicity is not fulfilled, since the EC10 for aquatic organisms is >= 0.01 mg/L (72 h, NOEC (Pseudokirchneriella subcapitata): => 74 mg/L (mean measured, TWA)); and the substance is not classified as carcinogenic, mutagenic or toxic for reproduction according to directive 67/548, or carcinogenic, germ cell mutagenic or toxic for reproduction according to Regulation EC No 1272/2008; and there is no evidence of chronic toxicity according to Directive 67/548/EEC, or specific target organ toxicity after repeated exposure according to Regulation 1272/2008.
Overall conclusion on PBT and vPvB
Based on the available information, the substance is not PBT / vPvB according to Regulation (EC) 1907/2006.
Reference
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