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

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

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 endpoints "long-term toxicity to aquatic invertebrates" or “short-term toxicity to aquatic invertebrates" 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".

It is possible to assess toxicity to aquatic invertebrates 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 tend to be poor. Therefore, a QSAR prediction cannot be reliably made for long-term toxicity of aquatic invertebrates 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 aquatic invertebrates, nor have such methods been validated by OECD.

Grouping, read-across and weight-of-evidence approaches are not considered in this case as no data on long term toxicity to aquatic invertebrates 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 211 "Daphnia magna Reproduction 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 aquatic invertebrates.

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:
OECD 211 " Daphnia magna Reproduction Test" is proposed in order to satisfy the need for further testing as stated in Annex IX, column 2.

Materials and methods

Test guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Test material

Test material information

Constituent 1

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