Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

Assessed Substance

Assessed substance:
substance itself
Reference
Reference substance name:
Unnamed
Inventory number:
InventoryMultipleMappingImpl [inventoryEntryValue=EC 206-793-1]
IUPAC name:
nonafluorobutane-1-sulfonic acid
Identity:
1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonic_acid
Identity:
1-Butanesulfonic acid, 1,1,2,2,3,3,4,4,4-nonafluoro-
Identity:
1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonic acid
CAS number:
375-73-5
Molecular formula:
C4HF9O3S
Molecular weight:
300.1
SMILES notation:
OS(=O)(=O)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F
InChl:
InChI=1/C4HF9O3S/c5-1(6,3(9,10)11)2(7,8)4(12,13)17(14,15)16/h(H,14,15,16)
Reference
Name:
PFBS pure
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status of the assessed substance:
the substance is not PBT / vPvB

Results of detailed PBT / vPvB assessment

Persistence

Evidence of non-P / non-vP properties
Screening criteria
Criteria based on Annex XIII of REACH
Further information for the PBT assessment is necessary
Remark:
PFBS is not expected to biodegrade or to undergo hydrolysis or photolysis. The substance is not readily biodegradable.
Conclusion
Conclusion on P / vP properties:
vP (and P)

Bioaccumulation

Evidence of non-B / non-vB properties
Screening criteria
Not B and not vB based on: Log Kow ≤ 4.5
Remark:
The substance shows a high water solubility of 50g/L
Criteria based on Annex XIII of REACH
Further information for the PBT assessment is necessary
Remark:
Bioaccumulation of PFBS has been studied and a number of reports are available in literature. Bioconcentration factors ranging from 0.30 to 1.44 have been reported, well below the REACH criteria of 2000 for B and 5000 for vB, respectively.
Conclusion
Conclusion on B / vB properties:
not B/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):
The 48-hour EC50 of PFBSK+ to Daphnia magna was examined in a static test conducted according to EPA 850.1010 and OECD TG 202. 20% cumulative immobilization was observed at 1707 mg/L, and 100% cumulative immobilization was observed at 9433 mg/L. The 48-hour EC50 was determined as 2183 mg/L.
Additional studies are available for long term aquatic and terrestric toxicity of PFBS, which show that NOEC values are well above the toxicity threshold of 0.01 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:
Sufficient long term data data are available for the source substance PFBSK+ which indicate that it is not to be classified as CMR Cat 1 or 2. Read across of this property to the target substance PFBS is valid for long term endpoints.
Other evidence of non-T properties
Remark:
2-hour EC50 of PFBSK+ to Pseudokirchneriella subcapitata was 5661 mg a.i./L
Evidence of T properties
Conclusion
Conclusion on T properties:
not T