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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 15th March 2017 to 14th April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Read across from very similar calcium benzenesulfonic acid that was not overbased; further justification is provided in category document
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A Buehler test was used for R&D purposes and worldwide acceptance, so an LLNA should not ethically be completed based on animal welfare reasons
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- A toltl number of 32 animals were utilised for the study. Twenty test animals, ten negative control animals, and two pilot animals were used. Prior to use, all animals were acclimated for at least five days. Animals were individually housed in wire mesh suspension cages. The animals were maintained on a 12-hour cycle light controlled room, at a temperature of 64° - 79°F and a relative humidity of 30-70%. The animals were maintained according to the recommendations contained in t Pig Chow and tap water ad libitum during both acclimation and test periods. There were no contaminants in either the feed or the water that would be expected to affect the outcome of this study
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Mineral Oil
- Concentration / amount:
- 0.4ml of 25% concentration of test substance
- Day(s)/duration:
- 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Mineral Oil
- Concentration / amount:
- 0.4ml of 10% concentration of test substance
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animmals used for both induction and challenge test.
- Details on study design:
- A pilot study was conducted using 2 animals to determine the concentration that produced mild dermal irritation at the application site which is then used for the inductions dose and the highest non irritating concentration of the test substance is then used as the challenge dose. The application site is prepared by removing hair from the back and sides of the trunk and four sites are selected for the irritation screening, 0.4ml of 5%, 10%, 25% and 50% of the test substance were applied to the test site and secured with micropore tape and further secured with kendal adhesive tape then left for 6 hrs after which the tape was removed and the irritation scores are taken a day after.
Similarly, application sites were prepared on test animals by shaving off hair and test substance is applied and secured with tape for 6hours after which tape is taken off and excess material wiped off. The test substance was administered to 20 young adults’ male Guinea pigs by dermal application at a dose volume of 0.4ml per application site for the Inductions and challenge. The does was based upon the appropriate amount of material sufficient to saturate the cotton pad in the Hilltop Chamber and allow for good skin contact of the test substance. Animals are scored for Irritation (erythema) at 24 and 48hours after completion of exposure. All animal body weight are taken before and after the study. In the challenge study, 6 negative control animals remained untreated through the induction phase and received primary challenge dose at 10% concentration of test substance. Four remaining guinea pigs were designated for a re-challenge if necessary.
All induction scores are recorded final challenge scores are reported after 24 and 48hrs. - Challenge controls:
- 6 negative control animals remained untreated through the induction phase and received primary challenge dose at 10% concentration of test substance. Four remaining guinea pigs were designated for a re-challenge if necessary.
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dintriobenzene: 0.3% in 80% ethanol for induction and 0.1% in acetone for challenge completed 18 days before this study was initiated
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% concentration - Challenge phase
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: 2 of 20 animals gave positive indication of skin sensitization
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% Concentration - Challenge phase
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% Concentration - Negative control
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% Concentration
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% in acetone
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% in acetone
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following primary challenge of test substance at 10% concentration, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced. Based on GHS guidelines < 15% of animals were sensitized to the material therefore, the Test substance is not classified for skin sensitization.
- Executive summary:
The Test substance was tested for dermal sensitization potential using a 25% induction concentration. The Test substance was evaluated for sensitization potential by applying 0.4 ml at a 25% concentration directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals. Two weeks after the final application the animals received a topical primary challenge dose (6hour contact) of test substance at 10% concentration, on a naive site located on the
right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application. Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 10% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.
Following primary challenge of test substance, at 10% concentration, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control
group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.
Based on GHS guidelines < 15% of animals were sensitized to the material, therefore, the Test substance is not classified for skin sensitization.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The read-across substance has been determined not to be sensitisers in guinea pig patch tests.
The test material and read-across substances have been determined to be non-sensitisers in human patch tests.
The read-across substance was Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts. This substance is very similar to the test substance except that it is not overbased. Further justification is provided in category document.
Low background incidences of sensitisation were observed among human volunteers, however, at levels that are considered to be not statistically significant. This lack of sensitisation in humans is further supported by human observations after exposure to the substance to be registered. Human sensitisation studies have been reported under ‘Exposure related observations in humans’.
.
Based on the weight of evidence provided, the test material is considered to be not sensitising.
Migrated from Short description of key information:
The read-across substance has been determined not to be a sensitiser in guinea pig patch tests.
The test material and read-across substances have been determined to be non-sensitisers in human patch tests.
Justification for selection of skin sensitisation endpoint:
The skin sensitisation endpoint has been addressed using both human and guinea pig read across studies and human studies on the test substance.
Human data presented under the endpoint “Sensitisation data (humans)” is also a key part of the weight of evidence for this endpoint. Two repeat insult patch tests using the substance to be registered and a further two studies performed on the read-across substances sodium 4-icosylbenzenesulfonate and sodium salt of sulfonated C15-C18 n-alpha-olefin, have also been provided to support the sensitisation dataset.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
Respiratory sensitisation has not been assessed.
Justification for classification or non-classification
Given that classification and labelling of chemicals is, by definition, a mechanism for the communication of hazard to humans, it is considered justifiable to assume a greater weight of relevance to data collected from human exposure compared to the data collected from exposure to guinea pigs. It is, therefore, considered justifiable to classify the substance according to the data available from human exposure.
Based on data available from human exposure, the substance is considered to be not sensitising in accordance with Regulation (EC) No. 1272/2008.
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.
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