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EC number: - | 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 (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July and August 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is similar to early test guidelines in compliance with GLP but without range finding data or concurrent assessment for irritation. As this data is used in a read-across approach Klimisch 2 is assigned.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca/Ola/Hsd strain
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Limited, Blackthorne, Bicester, Oxon, UK
- Housing: suspended stainless steel cages (18.4cm x 52.3cm x 12.7cm) with one solid sheet side and mesh front, floor, rear and remaining side
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of four days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 21±2°C
- Humidity (%): approximately 55±15%
- Air changes (per hr): approximately 25-30 air-changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- dimethylformamide
- Concentration:
- 0.1, 1, 10 or 30% w/v
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS: none reported
MAIN STUDY
- Test method: Approximately 25 µL of a 0.1, 1, 10 or 30% w/v concentration of the test sample in DMF was applied, using a variable volume micro pipette, to the dorsal surface of each ear, on three consecutive days .
- Criteria used to consider a positive response: one or more concentrations of the test chemical should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The sensitization potential of hexylcinnamaldehyde was assessed using the method described above. A vehicle control group was similarly treated using acetone.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The application of test material, at concentrations of 0.1, 1, 10 and 30% w/v in DMF, resulted in an increase in isotope incorporation which was greater than or equal to 3-fold at all four concentrations.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered sensitising to skin
- Executive summary:
The substance (Total Base Number = 13) was assessed using the LLNA study method in mice tested at 0.1, 1, 10 and 30% w/v in DMF. All concentrations achieved greater or equal to to 3 -fold increase in isotope incorporation conpared to solvent control and the substance is considered sensitising at all concenrtrations.
Reference
concentration (% w/v) |
number of lymphnodes assayed |
counts per minute (cpm) |
cpm per lymphnode(x102) |
test: control ratio |
0 (vehicle only) 0.1 1
10 30 |
8
8
8
8 8 |
511
1904
1539
5200
10463 |
0.64
2.38
1.92
6.50
13.08 |
N/A
3.72
3.00
10.16
20.44 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Classification and
Labelling Proposal for Benzenesulfonic acid, 4 -(mono-C15-36 branched
alkyl derivs., C24 rich), and benzenesulfonic acid, 4-octyadecyl, calcium
(EC No. 939-141-6) Classification
and Labeling is proposed and explained for Benzenesulfonic acid, 4
-(mono-C15-36 branched alkyl derivs., C24 rich) and benzenesulfonic acid,
4-octadecyl, calcium salts using data from skin sensitisation studies on
natural and synthetic calcium sulfonates. For Registration, Evaluation,
Authorization and Restriction of Chemicals (REACH) classification and
labeling, EU Classification, Labeling and Packaging of Substances and
Mixtures (CLP) Regulation (EC) No. 1272/2008 applies. In
the lubricant additive industry, a common name such as calcium sulfonate
is used for natural and synthetic long-chain alkylbenzenesulfonic acids,
calcium salts. Calcium sulfonates, which have surfactant properties, are
used as detergents in a broad variety of lubricant applications. In some
cases, excess calcium carbonate is added to the calcium sulfonates to add
acid buffering capacity (commonly known as “overbasing”). Calcium
sulfonates with a large excess of calcium carbonate are referred to as
high overbased or high total base number (TBN) calcium sulfonates, whereas
calcium sulfonates with small amounts of added calcium carbonate are
called low overbased or low TBN calcium sulfonates. Animal studies show
that calcium sulfonates with a TBN greater than 300 are not skin
sensitizers while the results in animals at a TBN of 300 exhibit a mixed
response. However, human repeat insult patch tests clearly show that high
TBN overbased calcium sulfonates (TBN ≥ 300) are not sensitisers and that
low TBN calcium sulfonates do not cause sensitization in a substantial
number of persons at concentrations of 10% or lower within the definition
of sensitisation under EU Regulation (EC) No. 1272/2008. Calcium
Sulfonate Skin Sensitisation: Low
TBN Calcium Sulfonates In
a key study the dermal sensitisation of this low TBN substance
(Benzenesulfonic acid, 4-(mono-C15 -36 branched alkyl derivs., C24 rich)
and benzenesulfonic acid, 4-octadecyl, calcium salts; EC 939-141-9; TBN =
13) was evaluated in the local lymph node assay (LLNA) (Lees, 1996).
Groups of male mice (4/group) were dose with approximately 25 µL of 0.1,
1, 10 or 30% concentrations of the test material in DMF on the dorsal
surface of each ear for three consecutive days. The animals were then
injected with 3H-methylthymidine, and the auricular lymph nodes where then
collected and prepared for scintillation counting. A three-fold or greater
increase in isotope incorporation was observed at all test concentrations.
Although investigators have reported that LLNA over predicts the
sensitisation potential of surfactants (Basketer & Kimber, 2011; Ball et
al., 2011), the positive response in this study is supportive of the
sensitisation response for low TBN calcium sulfonates noted in other
sensitisation studies. In
another key study the dermal sensitisation of an this low TBN substance (
Benzenesulfonic
acid, 4-(mono-C15-36 branched alkyl derivs., C24 rich) and benzenesulfonic
acid, 4-octadecyl, calcium salts; EC 939-141-9; TBN = 13)
was evaluated in guinea pigs (Bonnette, 1993b; Table 30). The animals were
treated topically with a 100% concentration of the test substance once per
week during the three week induction phase. Following a two week rest
period, the animals were topically challenged with a 50% concentration of
the test substance. After approximately one week the animals were
rechallenged with a 25% concentration of the test substance. Following the
first rechallenge, the animals then were rechallenged with a 10%
concentration of the test substance. The number of animals exhibiting
positive sensitisation responses for the test substance at 50%, 25%, and
10% were 9/10, 10/10, and 9/10, respectively, and the mean 24/48 hour
Draize scores were 1.9/2.1, 1.6/2.0, and 1.5/1.5, respectively. The mean
24/48 hour Draize scores for the naïve controls at 50%, 25%, and 10% were
0.2/0.2, 0.7/0.6, and 0.5/0.5, respectively. Based on these results the
test substance was determined to be a sensitiser. Table30.
Dermal Sensitisation Study (Modified Buehler Design) in Guinea Pigs with a
100% Low TBN Calcium Sulfonate (Benzenesulfonic acid, 4-(mono-C15-36
branched alkyl derivs., C24 rich) and benzenesulfonic acid, 4-octadecyl,
Calcium Salts; EC 939 -141 -6; TBN = 13) Induction: Challenge Results
(Bonnette, 1993b)
Group Concentration Mean Draize Score # Positive Conclusion 24 hours 24 hours Test 50%
1.9 2.1 9/10 Sensitizer Control 50%
0.2 0.2 Test 25%
1.6 2.0 10/10 Sensitizer Control 25%
0.7 0.6 Test 10%
1.5 1.5 9/10 Sensitizer Control 10%
0.5 0.5 Control = Topical application of test article to naive animals to account for primary irritation reactions Test Phase Concentration # Positive Responses Conclusion Study 24 hours 72 hours Induction 100% Sensitizer Shanahan & Erianne, 1993a Challenge 100% 9/44 6/44 Induction 20% Sensitizer Shanahan & Erianne, 1994c Challenge 20% 16/45* 16/45* Substance Challenge % Challenge Response Sensitization Response (%) Conclusion Study EC 263-093-9 (TBN = 30)
10% 7/142 with mild to moderate erythema/oedema including mild to moderate papular reactions; 1/142 with moderate erythema @ 24 hours and severe erythema @ 72 hours 8/142 (5.6) Sensitiser: low incidence with mild to moderate reactions in all but one of 8 subjects Alworth, Schwartz & Erianne, 1995c EC 263-093-9 (TBN = 30)
10% 3/205 with mild erythema @ original & virgin sites; 1/205 with moderate erythema @ both areas; 7/205 with mild erythema original site; 1/205 with mild erythema virgin site 12/205 (5.8) Sensitiser: low incidence with mild to moderate reactions Eisenberg, 1994c EC 616-278-7 (TBN = 13)
10% 2/154 with mild to moderate erythema with moderate papular reactions; 2/154 with mild to marked erythema and with moderate oedema and moderate papular reactions in the induction phase that were considered sensitised and, therefore were not challenged 4/154 (2.6) Sensitiser: low incidence with mild to moderate reactions Alworth, Schwartz & Erianne, 1995a EC 616-278-7 (TBN = 13)
10% 6/199 with mild erythema @ original sites; 5/199 with moderate erythema original site; 1/199 with moderate erythema virgin site 12/199 (6.0) Sensitiser: low incidence with mild to moderate reactions Eisenberg, 1994a EC 939-141-6 (TBN = 13)
10% 3/140 with mild to moderate erythema with mild to moderate oedema and/or mild to severe papular reactions in some; 1/140 with moderate erythema with mild to severe papular reaction including an adverse reaction report of reaction spreading to back/neck @ 96 hrs with erythema deminishing @ 192 hours but papular reaction spreading to the eyes 4/140 (2.9) Sensitiser: low incidence with mild to moderate reactions in all but one of 4 subjects Alworth, Schwartz & Erianne, 1995b EC 939-141-6 (TBN = 13)
10% 1/210 with mild erythema original and virgin site; 6/210 with BP to mild erythema original site; 5/210 moderate erythema original site; 1/210 with marked erythema original site; 1/210 with mild erythema virgin site; 1/210 with marked erythema original site 15/210(7.1) Sensitiser: low incidence with mild to moderate reactions Eisenberg, 1994b EC 616-278-7 (TBN = 85)
10% 2/48 with mild to moderate erythema and 1/48 with moderate oedema and papular that spread beyond contact site during induction were not challenged 3/48(6.3) Sensitiser: low incidence with mild to moderate reactions Shanahan & Erianne, 1994a EC 263-093-9 (TBN = 82)
10% 56/56 no reaction 0/56(0) Not a sensitiser Shanahan & Erianne, 1994e EC 263-093-9 (TBN = 100)
10% 51/51 no reaction 0/51(0) Not a sensitiser Shanahan & Erianne, 1994f EC 263-093-9 = Sulfonic acids, petroleum, calcium salts
EC 616-278-7 = Benzene, polypropene derivs., sulfonated, calcium salts
EC 939-141-6 =Benzenesulfonic acid, 4-(mono-C15-36 branched alkyl derivs., C24 rich) and benzenesulfonic acid, 4-octadecyl, calcium salts
Group Concentration Mean Draize Score # Positive Conclusion 24 hours 48 hours Test 25% 0.4 0.4 0/12 Not a sensitiser Control 25% 0.1 0.1 Test 25% 0.4 0.4 0/12 Not a sensitiser Control 25% 0.4 0.3 Test Phase Concentration #Positive Responses Conclusion Study 24 hours 72 hours Induction 100% Not a sensitiser Shanahan & Erianne, 1994d Challenge 100% 1/200 1/200 Induction 10% Not a sensitiser DiFiglia, Shanahan & Erianne, 1993c Challenge 10% 0/51 0/51 Induction 1% Not a sensitiser DiFiglia, Shanahan & Erianne, 1993d Challenge 1% 0/50 0/50 Test Phase Concentration #Positive Responses Conclusion Study 24 hours 72 hours Induction 100% Not a sensitiser Shanahan & Erianne, 1993b Challenge 100% 100%
1/222 1/222 Induction 10% Not a sensitiser Wachs, 1993 Challenge 10% 0/51 0/51 Induction 1% Not a sensitiser DiFiglia, Shanahan & Erianne, 1993a Challenge 1% 0/49 0/49 Induction 1% Not a sensitiser Shanahan & Erianne, 1994b Challenge 1% 0/49 0/49
Justification for classification or non-classification
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