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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: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD guidelines to to GLP, and therefore meets the requirements for Klimisch code 1. Study is classified as Klimisch code 2 only because it is based on read across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- A fuctional observation battery for neurotoxicity was not performed since this test was not par of the OECD 407 guideline at the time the study was performed
- GLP compliance:
- yes
Test material
- Reference substance name:
- analog 70024-69-0
- IUPAC Name:
- analog 70024-69-0
- Reference substance name:
- analog EC 274-263-7
- IUPAC Name:
- analog EC 274-263-7
- Details on test material:
- The test material was a direct analog of CAS 70024-69-0 described as C20-24 alkaryl calcium salt deriviative.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 41 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Mixed weekly weight/volume in peanut oil.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chemical analysis of dosing solutions was conducted to confirm that they were homogeneous and met the desired concentrations.
- Duration of treatment / exposure:
- 29 day treatment duration with a 14 day recovery period.
- Frequency of treatment:
- 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
gavage doses of 0, 100, 500 or 1000 mg/kg/bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Details on study design:
- - dose selection rationale: Data from a pilot two week repeated dose oral study.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Tests applied included; parametric ANOVA with Dunnetts post-hoc test, non parametric Kruskal-Walls and Mann-Whitney U test, Bartletts test for equal variances, Students t test and Dixons test for rejection of outlying values.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
One animal was sacrificed on Day 0 and one animal was found dead on Day 9, result of probable misdosing.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Mean serum cholestrol levels were significantly reduced in the 1000 mg/kg males and females at termination of dosing. This was still significantly reduced in 1000 mg/kg females at the end of the 14 day recovery period.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Average body weights and body weight gains during 29 days of treatment
Dose rate (mg/kg |
Body Weights (g)
|
Total Weight Gain |
|||||
Week 0 |
Week 1 |
Week 2 |
Week 3 |
Week 4 |
g |
% of control |
|
Male |
|||||||
0 |
195 |
243 |
286 |
323 |
352 |
157 |
N/A |
100 |
196 |
245 |
298 |
340 |
374 |
178 |
111 |
500 |
200 |
245 |
289 |
329 |
362 |
162 |
103 |
1000 |
193 |
240 |
283 |
315 |
346 |
153 |
97 |
Female |
|||||||
0 |
155 |
175 |
194 |
213 |
223 |
68 |
N/A |
100 |
156 |
174 |
194 |
215 |
228 |
72 |
106 |
500 |
154 |
175 |
190 |
212 |
221 |
67 |
99 |
1000 |
155 |
174 |
195 |
212 |
224 |
69 |
101 |
Applicant's summary and conclusion
- Conclusions:
- A NOAEL of 500 mg/kg bw/day was identified in this study.
- Executive summary:
In a subchronic toxicity study calcium sulphonate was administered to 12 Sprague-Dawley rats/sex/dose in the control and top dose groups and 6 animals Sprague-Dawley rats/sex/dose in the low and mod dose via gavage at dose levels of 0, 100, 500 or 1000 mg/kg bw/day). A decrease in serum cholesterol levels occurred in the top dose group. The LOAEL is 1000 mg/kg bw/day, based on a decrease in serum cholesterol at the top dose. The NOAEL is 500 mg/kg bw/day. This subchronic toxicity study in the rat is acceptable and satisfies the guideline requirement for a subchronic oral study (OPPTS 870.3100; OECD 408) in rats.
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