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EC number: 239-854-6
CAS number: 15763-76-5
Persistence: As defined in the ‘Read-Across Justification
Document’ section 13, data provided for the hydrotropes category are
representative of sodium p-cumenesulphonate and suitable for assessment
purposes. A GLP guideline study using sodium toluene sulphonate (CAS
657-84-1) reported almost complete biodegradation by the end of the
28-day test of 99.8% and met the 10-day window criterion with more than
60% degradation recorded after 7 days (Brunswick-Titze, 2004). Evidence
of ready biodegradability from studies for hydrotrope category
substances tested using OECD guideline methods supports the conclusion
that sodium p-cumenesulphonate is readily biodegradable. In addition,
the OECD SIDS Report (2006) for the hydrotropes category concluded that
“studies across the hydrotropes category demonstrate rapid and complete
biodegradation under aerobic conditions and the hydrotropes are
considered to be readily biodegradable according to OECD criteria”. The
OECD SIDS Report conclusion supports the experimental evidence provided
and the substance is considered to be not persistent. According to ECHA
Guidance on PBT assessment, no further testing is required to conclude
the P criterion.
Bioaccumulation: The likelihood of bioaccumulation is
considered to be very low based on the evidence from a measured
partition coefficient for sodium p-cumenesulphonate (log Kow of -1.1)
and scientific evidence in the published literature. Reliable
experimental studies carried out in accordance with OECD Guideline 305C
determined bioconcentration factors of <2.3 for two hydrotrope category
substances published in the OECD SIDS Report for hydrotope category
substances (2006). Sodium p-cumenesulphonate does not fulfil the
criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”. According
to ECHA Guidance on information requirements and chemical safety
assessment (November 2012), Chapter R.11, Figure 11-2: Integrated
testing strategy for B-assessment, no further testing is required to
conclude the bioaccumulation criterion.
Toxicity: Available reliable data for the long-term aquatic
toxicity of hydrotrope category substances shows the NOEC is greater
than 0.01 mg/L and the substances does not fulfill the criterion for
toxicity according to ECHA guidance on PBT assessment. Additionally,
short-term acute toxicity (LC50or EC50) to aquatic
organisms is greater than 0.01 mg/L and does not meet the screening
toxicity criterion according to the ECHA guidance on PBT assessment
(Part C). There is no evidence of chronic toxicity
considering human health and no classification as carcinogenic (category
1 or 2), mutagenic (category 1or 2) or toxic for reproduction (category
1, 2, or 3) according to Directive 67/548/ECC. Therefore,
it can be concluded that the substance does not fulfill the toxicity (T)
criterion as laid down in Annex XIII of regulation (EC) No 1907/2006
(amended March 2011 as No 253/2011).
The overall conclusion is that sodium p-cumenesulphonate does
not meet the PBT or vPvB criteria. No further testing is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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