Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Justification for type of information:
NON-CONFIDENTIAL NAME OF SUBSTANCE: Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies
- Available non-GLP studies
- (Q)SAR
- In vitro methods
- Weight of evidence
- Grouping and read-across
- Substance-tailored exposure driven testing [if applicable]
- Approaches in addition to above [if applicable]
- Other reasons [if applicable]

No GLP or non-GLP studies are available which cover the endpoint "long-term toxicity to fish" for "Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50".

A short-term study is available in Sheepshead minnow (Cyprinodon variegatus), a salt-water species of fish. In a 96-hour acute toxicity study, Cyprinodon variegatus Sheepshead minnow (Cyprinodon variegatus) were exposed to registered substance, at nominal concentrations of 0 and 10000 mg/L WSF under static renewal conditions. The 96 -hour LL50was >10,000 mg/L nominal WSF. No signs of toxicity were noted in either the control or test samples. This toxicity study is classified as acceptable and satisfies the guideline requirement for a fish acute toxicity study. However, it is not suitable for assessment of chronic toxicity to fish. Therefore, there is a data gap for the endpoint ‘Long-term toxicity to fish’.

It is possible to assess toxicity to fish of some substances by (Q)SAR. However, "Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50" is a UVCB substance, and as such, the development of reliable predictions is problematic. Furthermore, the data sets for QSARs for long-term endpoints in fish tend to be poor. Therefore, a QSAR prediction cannot be reliably made for long-term toxicity of fish for "Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50".

No in vitro data are available for the long-term toxicity of fish. In vitro studies are not considered suitable in this case as the available validated OECD methods (e.g. OECD 229, OECD 330) measure only specific endpoints related to reproductive or endocrine effects (e.g. vitellogenin induction). These studies will not inform on ‘general’ toxicological effects that may be observed from an in vivo study. Furthermore, due the low solubility of the test substance, it is unlikely that it would be possible to maintain concentrations of the test substance in solution for the duration of these assays.
Grouping, read-across and weight-of-evidence approaches are not considered in this case as no data on long term toxicity to fish are available that are suitable for read-across to cover the endpoint.

Overall, the registrant has carefully considered all general adaption procedures as listed in Annex XI of the REACH regulation, however the registrant has come to the conclusion that the lack of available data through studies and the level of extensiveness of the study proposed herein, the conduction of an OECD 210 " Fish, Early-life Stage Toxicity Test" is considered the best course of action in order to elucidate the long-term toxicity of "Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50" to fish.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Column 2 of Annex VI to X, specifically Annex IX, column 2, states clearly that a test of long-term toxicity behaviour shall be proposed by the registrant if after careful evaluation of Annex I and the corresponding safety evaluation there is a need for further evaluation of the toxicity of the substance towards aquatic organisms. OECD 210 " Fish, Early-life Stage Toxicity Test" is proposed in order to satisfy the need for further testing as stated in Annex IX, column 2. Due to the low solubility of the test substance, this study would be conducted using WAF.

Data source

Materials and methods

Test guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50
EC Number:
701-356-6
Cas Number:
91696-74-1
Molecular formula:
Cannot be adequately determined for this UVCB substance
IUPAC Name:
Benzenesulfonic acid, mono- and dialkylation products with C16-20 (even numbered, branched and linear) olefins, calcium salts, calcium carbonate, overbased, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50
Test material form:
liquid
Details on test material:
Actual material tested was HiTEC E 611

Results and discussion

Applicant's summary and conclusion