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EC number: 947-519-7 | 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
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- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 13 February 1991 and 23 March 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. However, as the study is used in a read across approach, Klimisch 2 is assigned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Buehler E.V.., Arch Dermatol, 91:171, 1965).
- Deviations:
- no
- Principles of method if other than guideline:
- The objective of the study was to determine the ability of the test material to induce delayed contact hypersensitivity when applied in close contact to the skin of albino guinea pigs (Buehler, E.V., Arch Dermatol, 91:171, 1965).
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- According to OECD 429 guideline, „despite the advantages of the LLNA over TG 406, it should be recognised that there are certain limitations that may necessitate the use of TG 406 (13) (e.g. false negative findings in the LLNA with certain metals, false positive findings with certain skin irritants [such as some surfactant type chemicals]…” Basketer & Kimber (2011) and Ball et al. (2011) conducted a battery of in vivo and in vitro tests with several exemplary surfactant and confirmed that the LLNA tends to overestimate the sensitization potential of surfactants. Even though the registered substance calcium sulfonate has no surfactant properties, the read across substances are in several cases, and the Buehler tests (OECD TG 406) conducted with the calcium sulfonate read-across substances are more appropriate to differentiate between the skin sensitization potential of low and high TBN calcium sulfonates. 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. The results of numerous animal studies and human repeat insult patch tests clearly showed that low TBN calcium sulfonates (TBN < 300) are skin sensitisers with a specific concentration limit (SCL) of 10% and that high TBN calcium sulfonates (TBN ≥ 300) are not skin sensitisers. Thus, to confirm this assumption Buehler test was chosen.
Test material
- Reference substance name:
- Reference substance 003
- Cas Number:
- 61789-86-4
- Test material form:
- other: semi-solid
- Details on test material:
- Date recieved: February 5, 1991
Ourity: Test material purity data are the responsibility of the Sponsor.
Stability: Stable under normal storage conditions
Physical description: Light tan semi-solid
Storage conditions: Sealed container at room temperature.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Species: Guinea pig
Strain: Hartley albino
Source: Murphy Breeding Laboratories, Inc. Plainfield, Indiana
Number: Fifteen males and fifteen females on the main study and four males and four females on the Primary Irritation Phase
Bodyweight: 299 to 361 grams on study day -1, (excluding Primary Irritation Phase animal)
Age at start of study: Young adult
Method of identification: Cage label
Housing: Individual suspended wire-mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc.in accordance with standard operating procedures.
Quarantine: The animals used on the main study were acclimated to laboratory conditions for a minimum of 7 days prior to study initiation.
Food and water: Purina Certified Guinea Pig Chow #5026 (ad libitum) and tap water from on site wells (ad libitum). Water is analyzed twice yearly in accordance with. S.O.P. No. A"-020. Results of analyses are available upon Sponsor request. It should be noted that beginning on February 24, 1991, Purina Certified Guinea PigChow #5026 could not be obtained from the supplier and Purina Guinea Pig Chow#5025 was fed ad libitum until March 14, 1991. There are no contaminants known which would be expected to interfere with the study. Therefore, this deviation has no effect on the scientific validity, integrity or objective of the study.
Environmental conditions: Animal room with controlled temperature (69-76°F), humidity (30-69%) and light (12 hours light/12 hours dark).
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: light white mineral oil
- Concentration / amount:
- 100% w/w - Induction
25% w/w - challenge
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: light white mineral oil
- Concentration / amount:
- 100% w/w - Induction
25% w/w - challenge
- No. of animals per dose:
- 12 - main study
6 - Naive Control I
6 - Naive Control II - Details on study design:
- The study consisted of four phases. The Primary Irritation Phase consisted of single applications of multiple concentrations of the test material to determine irritation thresholds. The Induction Phase consisted of multiple applications of test material to stimulate the immune system. The Challenge Phase consisted of single applications of the maximal nonirritating concentration of test material to determine if delayed contact hypersensitivity had occurred. The Rechallenge Phase consisted of single applications of the maximal nonirritating concentration of the test material to confirm challenge results.
The Primary Irritation Phase utilized eight guinea pigs and evaluated five different concentrations of test material and the vehicle for selection of the appropriate induction and challenge concentrations. The main study which included induction, challenge and rechallenge utilized a Test Group of twelve guinea pigs that were induced with multiple applications of test material and a Naive Control I and II Group of six guinea pigs each that were dosed only at the Challenge and Rechallenge Phases, respectively. In addition, the main study included a Positive Control Group of six guinea pigs. The Positive Control Group was induced and challenged on an identical regimen as the Test Group and employed a known dermal sensitizer to prove the reliability of the test system.
Animals used on the Primary Irritation Phase were arbitrarily selected from available stock. Animals used on the main study were selected from available stock and assigned to groups by straight, unstratified randomization through use of the WIL Research Laboratories Inc. Computer, Data Management System. It should be noted that one Naive Control Group II male guinea pig died from mechanical injury on Day 0. Male 02003229 was arbitrarily selected from available stock as a replacement animal.
Test Material Administration:
The guinea pigs backs were clipped with an electric clipper on the day prior to each dosing. The prepared test and positive control material solutions were maintained on a magnetic stir plate during dosing.
Primary Irritation Phase:
The diluted test materials were administered at 0.4 mL/site for weight to weight concentrations in light white mineral oil and at 0.4 g/site for 100% concentrations. The vehicle, light white mineral oil, was administered at 0.4 mL/site. Doses were applied under 25 mm Hilltop Chambers that were occluded with plastic wrap and overwrapped with 75 mm Elastoplast Tape. There were three test sites per guinea pig. The period of exposure was six hours after which the bandages were removed and wiped with disposable paper towels moistened with light, white mineral oil.
Induction Phase:
Doses of calcium sulfonate and the prepared positive control material (0.25% w/v DNCB in 80% ethanol) were applied at 0.4 mL/site to the appropriate animals. Doses were applied under 25 mm Hilltop Chambers, occluded with plastic wrap and overwrapped with 7.5 mm Elastoplast Tape
Induction doses were applied to the same site on the left flank of all Test and Positive Control Group animals except that all sites in the Positive Control Group were moved anterior to the previous sites for the third induction dose. Test and Positive Control Group animals each received three induction doses spaced one week apart over a period of three weeks. All induction exposures were six hours, after which the bandages were removed. In the Test Group, the test material was removed using disposable paper towels moistened with light, white mineral oil. Positive Control Group animals were washed with disposable paper towels moistened with tepid tap water.
All naive control animals remained untreated during the Induction Phase.
Challenge Phase:
Fourteen days after the final induction dose, the test and positive control materials were administered to a previously unexposed site on the right anterior flank of the appropriate animals. Doses were applied under 25 mm Hilltop Chambers that were occluded with plastic wrap and overwrapped with 75 mm Elastoplast Tape. The exposure period was six hours after which the bandages were removed and the sites washed with disposable paper towels moistened with light, white mineral oil for the Test and Naive Control I Groups and tepid tap water for the Positive Control Group.
Test and Naive Control I Group animals were dosed at 0.4 mL/site with 25% w/v calcium sulfonate (CAS 61789-86-4) in light, white mineral oil. Positive Control Group animals were dosed with 0.1% w/v dinitrochlorobenzene in 80% ethanol at 0.4 mL/site.
Rechallenge Phase:
One week after the initial challenge, the test material CAS 61789-86-4 was administered to a previously unexposed site on the right posterior flank of the Test Group and Naive Control II Group animals. Doses were applied under 25 mm Hilltop Chambers that were occluded with plastic wrap and overwrapped with 75 mm Elastoplaste Tape. The exposure period was six hours after which the bandages were removed and the sites washed with disposable paper towels moistened with light, white mineral oil. Test and Naive Control II Group animaIs were dosed at 0.4 mL/site with 25% w/w calcium sulfonate (CAs 61789-86-4) in light,white mineral oil. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
Results and discussion
- Positive control results:
- Reactions in Positive Control Group guinea pigs challenged with 0.1% w/v dinitrochlorobenzene in 80% ethanol included two moderate (grade 2), and three slight (grade 1) reactions at 24 hours. There were three slight (grade 1) reactions at 48 hours. There were one and three very slight (grade ±) reactions at 24 and 48 hours respectively.
The positive control material dinitrochlorobenzene was demonstrated to be a strong sensitizing agent under the conditions of this study based on the sensitization incidence index of 83%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% calcium sulfonate in light white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% calcium sulfonate in light white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Light white mineral oil
- 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:
- Light white mineral oil
- 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% DNCB
- No. with + reactions:
- 5
- Total no. in group:
- 6
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% DNCB
- No. with + reactions:
- 3
- Total no. in group:
- 6
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% calcium sulfonate in light white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% calcium sulfonate in light white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Light white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Light white mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Mortality: It should be noted that a Naive Control II Group male died on study day 0 as a result of a laboratory accident. A broken back and the abdominal and thoracic cavities filled with clotted red material were noted at the necropsy. This animal was immediately replaced with a male from available stock in order to obtain a full complement of guinea pigs in Naive Control Group II. There were no other deaths during the study. Clinical Observations Tables 1 and 4: Test Group male #02003239 had soft stool at study termination. There were no other clinical findings during the study.
Project No.: WIL-168017 | Table 1 | ||
Skin Sensitisation Study in Albino Guinea Pigs | |||
Clinical Observations - Primary Irritation Phase - Total Incidence/No. of Animals | |||
Table Range | Day 0 | Day 2 | |
No significant clinical observations | 8/8 | 8/8 |
Table 4 | ||||||
Project No.: WIL-168017 |
Skin Sensitization Study in Albino Guinea Pigs | |||||
Summary of clinical findings: Total occurrence/No. Of Animals | ||||||
Male | ||||||
Table Range: | Day -1 | |||||
Group | 1 | 2 | 3 | 4 | ||
No significant clinical observations | 6/6 | 3/ 3 | 3/3 | 3/3 | ||
Table Range: | Day 30 | |||||
Group | 2 | 3 | ||||
No significant clinical observations | 3/ 3 | 3/ 3 | ||||
Table Range: | Day 37 | |||||
Group | 1 | 4 | ||||
No significant clinical observations | 5/ 5 | 3/ 3 | ||||
Soft stool | 1/ 1 | 0/ 0 | ||||
Female | ||||||
Table Range: | Day -1 | |||||
Group | 1 | 2 | 3 | 4 | ||
No significant clinical observations | 6/ 6 | 3/ 3 | 3/ 3 | 3/ 3 | ||
Table Range: | Day 30 | |||||
Group | 2 | 3 | ||||
No significant clinical observations | 3/ 3 | 3/ 3 | ||||
Table Range: | Day 37 | |||||
Group | 1 | 4 | ||||
No significant clinical observations | 6/ 6 | 3/ 3 | ||||
1 - Test group | ||||||
2 - positive control | ||||||
3 - naive control - I | ||||||
4 - naive control - II |
- Body Weights Tables 2 and 5: There were no remarkable changes or differences observed in body weights.
Project No.: WIL-168017 | Table 2 | ||
Skin Sensitisation Study in Albino Guinea Pigs | |||
Individual Body Weights (grams) - Primary Irritation Phase | |||
Anima] Number | Sex | Day | |
0 | 2 | ||
01002981 | M | 527 | 509 |
01002986 | M | 568 | 564 |
01002987 | M | 603 | 604 |
01002988 | M | 543 | 534 |
01002966 | F | 632 | 604 |
01002967 | F | 672 | 659 |
01002968 | F | 586 | 568 |
01002969 | F | 600 | 583 |
M = Male | |||
F = Female |
Table 5 | ||
PROJECT NO. :WIL-168017 | ||
Skin Sensitization Study in Albino Guinea Pigs | ||
Individual Body weights (Grams) | ||
Male Group: Test Group | ||
Day | -1 | 37 |
Animal | ||
2003218 | 326 | 647 |
2003235 | 315 | 610 |
2003239 | 311 | 592 |
2003249 | 361 | 758 |
2003257 | 310 | 609 |
2003264 | 318 | 542 |
Mean | 324 | 626 |
S.D. | 19.3 | 73.0 |
N | 6 | 6 |
Male Group: Positive Control | ||
Day | -1 | 30 |
Animal | ||
2003222 | 309 | 554 |
2003236 | 348 | 685 |
2003265 | 310 | 624 |
MEAN | 322 | 621 |
S.D. | 22.2 | 65.6 |
N | 3 | 3 |
Male Group: Naive Control-I | ||
Day | -1 | 30 |
Animal | ||
2003221 | 323 | 585 |
2003251 | 341 | 535 |
2003263 | 359 | 610 |
MEAN | 341 | 577 |
S.D. | 18.0 | 38.2 |
N | 3 | 3 |
Male Group: Naive Control-II | ||
Day | -1 | 37 |
Animal | ||
2003240 | 320 | 631 |
2003229 | 299 | 640 |
2003260 | 327 | 479 |
MEAN | 315 | 583 |
' S.D. | 14.6 | 90.5 |
N | 3 | 3 |
Female Group: Test Group | ||
Day | -1 | 37 |
Animal | ||
2003272 | 318 | 486 |
2003278 | 322 | 497 |
2003279 | 325 | 505 |
2003281 | 324 | 490 |
2003305 | 303 | 511 |
2003315 | 343 | 518 |
MEAN | 323 | 501 |
S.D. | 12.9 | 12.4 |
N | 6 | 6 |
Female Group: Positive Control | ||
Day | -1 | 30 |
Animal | ||
2003284 | 320 | 496 |
2003302 | 325 | 518 |
2003309 | 336 | 533 |
MEAN | 327 | 516 |
S.D. | 8.2 | 18.6 |
N | 3 | 3 |
Female Group: Naive Control-I | ||
Day | -1 | 30 |
Animal | ||
2003301 | 302 | 511 |
2003310 | 321 | 476 |
2003311 | 314 | 507 |
MEAN S.D. | 312 | 498 |
S.D. | 9.6 | 19.2 |
N | 3 | 3 |
Female Group: Naive Control-II | ||
Day | -1 | 37 |
Animal | ||
2003280 | 345 | 636 |
2003287 | 307 | 472 |
2003316 | 342 | 551 |
MEAN | 331 | 553 |
S.D. | 21.1 | 82.0 |
N | 3 | 3 |
Dermal Observations: Induction Phase Table 6: The 100% of the test item induced eight and six grade ± reactions at the 24 -hour and 48 -hour readings, respectively, following the first induction dose. After the second induction dose there were two grade 1 reactions at 24 -hours and six grade ± reactions at the 24-hour and 48-hour readings. Ten and four grade ± reactions were noted at the 24-hour and 48-hour readings after the third induction dose. Five grade ± reactions and one grade 1 reaction was noted on positive control animals after the first induction dose. Grade ± and 1 reactions were present on all positive control animals after the second induction dose. Grade ±, 1 or 2 reactions were present on all animals following the third induction dose. Four animals had necrosis after the third induction dose. -
PROJECT NO.: WIL-168017 | |||||||
Table 6 | |||||||
Skin Sensitization Study in Albino Guinea Pigs | |||||||
Individual Dermal Reactions - Induction Phase (Test Group)* | |||||||
Animal | Sex | 1st Induction | 2nd Induction | 3rd Induction | |||
24 Hour | 48 Hour | 24 Hour | 48 Hour | 24 Hour | 48 Hour | ||
02003218 | M | ± | ± | ± | ± | ± | 0 |
02003235 | M | 0 | ± | 1 | ± | ± | ± |
02003239 | M | ± | ± | 1 | ± | ± | 0 |
02003249 | M | ± | 0 | ± | ± | ± | 0 |
02003257 | M | 0 | 0 | ± | 0 | 0 | 0 |
02003264 | M | ± | ± | 0 | 0 | ± | ± |
02003272 | F | ± | 0 | 0 | 0 | 0 | 0 |
02003278 | F | 0 | 0 | 0 | 0 | ± | 0 |
02003279 | F | 0 | 0 | 0 | 0 | ± | 0 |
02003281 | F | ± | 0 | ± | ± | ± | 0 |
02003305 | F | ± | ± | ± | 0 | ± | ± |
02003315 | F | ± | ± | ± | ± | ± | ± |
Individual Dermal Reactions - Induction Phase (Posivitve Control Group)** | |||||||
Animal | Sex | 1st Induction*** | 2nd Induction*** | 3rd Induction*** | |||
24 Hour | 48 Hour | 24 Hour | 48 Hour | 24 Hour | 48 Hour | ||
02003222 | M | ± | ± | 1 | ± | ±n | ±n |
02003236A | M | ± | ± | 1 | 1 | ± | ±n |
02003265 | M | ± | 0 | 1 | 1 | 1n | 1n |
02003284 | F | ± | 0 | 1 | 1 | 1 | 1 |
02003302 | F | ± | ± | 1 | 1 | 1 | 1n |
"02003309 | F | 1 | ± | 1 | ± | 2n | 1n |
* = Dosed with 0.4 g of 100% | |||||||
** = Dosed with 0.4 mL of 0.25% w/v concentration of dinitrochlorobenzene in 80% ethanol. | |||||||
***= All dose sites stained yellow | |||||||
M = Male | |||||||
F = Female | |||||||
n = Necrosis | |||||||
A = Dose site moved anterior to previous dose site for third induction dose. |
Challenge Phase Tables 7 and 8: There were ten grade 1 reactions at 24 and 48 hours for Test Group guinea pigs challenged with 25% w/w of the test item (CAS 61789 -86 -4) in light, white mineral oil. There was one very slight (grade ± reaction at 24 and 48 hours for Naive Control I Group guinea pigs challenged with 25% w/w of the test item in light, white mineral oil. Reactions in Positive Control Group guinea pigs challenged with 0.1% w/v dinitrochlorobenzene in 80% ethanol included two moderate (grade 2), and three slight (grade 1) reactions at 24 hours. There were three slight (grade 1) reactions at 48 hours. There were one and three very slight (grade ±) reactions at 24 and 48 hours, respectively.
PROJECT NO.: WIL-168017 | |||
Table 7 | |||
Skin Sensitization Study in Albino Guinea Pigs | |||
Individual Dermal Reactions - Challenge Phase (Test Group)* | |||
Animal | Sex | Observation Period | |
24 Hour | 48 Hour | ||
02003218 | M | 0 | 0 |
02003235 | M | ± | ± |
02003239 | M | ± | ± |
02003249 | M | ± | ± |
02003257 | M | ± | ± |
02003264 | M | 0 | 0 |
02003272 | F | ± | ± |
02003278 | F | ± | ± |
02003279 | F | ± | ± |
02003281 | F | ± | ± |
02003305 | F | ± | ± |
02003315 | F | ± | ± |
Individual Dermal Reactions - Challenge Phase (Naive Control Group-I)** | |||
Animal | Sex | Observation Period | |
24 Hour | 48 Hour | ||
02003221 | M | ± | ± |
02003251 | M | 0 | 0 |
02003263 | M | 0 | 0 |
02003301 | F | 0 | 0 |
02003310 | F | 0 | 0 |
02003311 | F | 0 | 0 |
Individual Dermal Reactions - Challenge Phase (Positive Control Group)*** | |||
Animal | Sex | Observation Period | |
24 Hour | 48 Hour | ||
02003222 | M | 2 | 1 |
02003236 | M | 2 | 1 |
02003265 | M | 1 | ± |
02003284 | F | 1 | 1 |
02003302 | F | ± | + |
02003309 | F | 1 | ± |
* = Dosed with 0.4 mL of 25% w/w of the test item in light, white mineral oil. | |||
** = Dosed with 25% w/w of the test item in light, white mineral oil. | |||
*** = Dosed with 0.4 mL of 0.1%w/v concentration of dinitrochlorobenzene in 80% ethanol. | |||
M = Male | |||
F = Female |
PROJECT NO.: WIL-168017 | |||||||||
Table 8 | |||||||||
Skin Sensitization Study in Albino Guinea Pigs | |||||||||
Incidence of Dermal Responses at Challenge | |||||||||
Group | Material | Interval | Dermal Scores | Number of Animals | Irritation Severity Index | ||||
0 | ± | 1 | 2 | 3 | |||||
Test | 25% of the test item in light, white mineral oil | 24 HR. | 2 | 10 | 0 | 0 | 0 | 12 | 0.4 |
48 HR. | 2 | 10 | 0 | 0 | 0 | 12 | 0.4 | ||
Naive Control-I | 25% of the test item in light, white mineral oil | 24 HR. | 5 | 1 | 0 | 0 | 0 | 6 | 0.1 |
48 HR. | 5 | 1 | 0 | 0 | 0 | 6 | 0.1 | ||
Positive Control | 0.1% DNCB | 24 HR. | 0 | 1 | 3 | 2 | 0 | 6 | 1.3 |
48 HR. | 0 | 3 | 3 | 0 | 0 | 6 | 0.8 | ||
HR. = Hours | |||||||||
DNCB = Dinitrochlorobenzene |
Rechallenge Phase Tables 9 and 10: There were ten grade ± reactions at 24 hours for Test Group guinea pigs rechallenged with 25% w/w of the test item in light, white mineral oil. Nine grade ± reactions were noted at 48 hours. There were five very slight grade ± reactions at 24 hours for Naive Control Group II guinea pigs rechallenged with 25% w/w of the test item in light, white mineral oil. There were three very slight (grade ±) reactions at 48 hours.
PROJECT NO.: WIL-168017 | |||
Table 9 | |||
Skin Sensitization Study in Albino Guinea Pigs | |||
Individual Dermal Reactions - Rechallenge Phase (Test Group)* | |||
Animal | Sex | Observation Period | |
24 Hour | 48 Hour | ||
02003218 | M | ± | ± |
02003235 | M | ± | ± |
02003239 | M | ± | ± |
02003249 | M | ± | ± |
02003257 | M | ± | ± |
02003264 | M | ± | 0 |
02003272 | F | 0 | 0 |
02003278 | F | 0 | 0 |
02003279 | F | ± | ± |
02003281 | F | ± | ± |
02003305 | F | ± | ± |
02003315 | F | ± | ± |
Individual Dermal Reactions - Rechallenge Phase (Naive Control-II Group)** | |||
Animal | Sex | Observation Period | |
24 Hour | 48 Hour | ||
02003240 | M | ± | ± |
02003229 | M | 0 | 0 |
02003260 | M | ± | ± |
02003280 | F | ± | ± |
02003287 | F | ± | 0 |
02003316 | F | ± | 0 |
* = Dosed with 0.4 mL of 25% w/w of the test item in light, white mineral oil. | |||
** = Dosed with 25% w/w of the test item in light, white mineral oil. | |||
M = Male | |||
F = Female |
PROJECT NO.: WIL-168017 | |||||||||
Table 10 | |||||||||
Skin Sensitization Study in Albino Guinea Pigs | |||||||||
Incidence of Dermal Responses at Rechallenge | |||||||||
Group | Material | Interval | Dermal Scores | Number of Animals | Irritation Severity Index | ||||
0 | ± | 1 | 2 | 3 | |||||
Test | 25% of the test item in light, white mineral oil | 24 HR. | 2 | 10 | 0 | 0 | 0 | 12 | 0.4 |
48 HR. | 3 | 9 | 0 | 0 | 0 | 12 | 0.4 | ||
Naive Control-II | 25% of the test item in light, white mineral oil | 24 HR. | 1 | 5 | 0 | 0 | 0 | 6 | 0.4 |
48 HR. | 3 | 3 | 0 | 0 | 0 | 6 | 0.3 | ||
HR. = Hours |
Incidence and Severity Indices: The Sensitization Incidence Index was calculated to be 0/12 (0%) for the Test Group following challenge and rechallenge dosing. The Irritation Severity Index was 0.4 at 24 and 48 hours for the Test Group at challenge and rechallenge. The Irritation Severity Indices were 0.4 and 0.3 at 24 and 48 hours, respectively, for the Naive Control II Group. The Sensitization Incidence Index was calculated to be 5/6 (83%) for the Positive Control Group following challenge dosing. The Irritation Severity Indices were 1.3 and 0.8 at 24,and 48 hours, respectively, for the Positive Control Group. Ranking of Sensitization Potential: Based on the Sensitization Incidence Index of 0% following challenge and rechallenge dosing the test material, calcium sulfonate (CAS 61789 -86 -4) was found to be a nonsensitizing agent in the albino guinea pig under the conditions of this study. The positive control material, dinitrochlorobenzene, was demonstrated to be a strong sensitizing agent under the conditions of this study based on the sensitization incidence index of 83%.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- There were no test material related deaths, clinical findings or body weight changes.
No sensitization reactions were observed in the Test Group following challenge and rechallenge dosing.
The Sensitization Incidence Index for the Test Group was 0%.
The positive control material, dinitrochlorobenzene, was demonstrated to be a strong sensitizing agent in albino guinea pigs under the conditions of this study based on the Sensitization Incidence Index of 83%, thereby demonstrating the reliability of the test system.
Based on the data obtained, the test material, the calcium sulfonate (CAS 61789-86-4) was found to be a nonsensitizing agent in albino guinea pigs under the conditions of this study. - Executive summary:
The sensitisation potential of the calcium sulfonate (CAS - 61789 -86 -4, Total Base Number = 375) was evaluated in this modified Buehler method dermal sensitisation study (Kiplinger, 1992A). A Test Group of six male and six female Hartley albino guinea pigs was dosed topically with the calcium sulfonate test substance one time per week for three weeks for a total of three induction exposures. The duration of the exposures was six hours. Two weeks after the last induction exposure, Test Group animals were challenge dosed for detection of sensitisation by topical application of a known nonirritating concentration of the calcium sulfonate test substance to previously unexposed areas of skin. One week after challenge dosing, Test Group animals were rechallenged to confirm the initial challenge results. (The calcium sulfonate test substance concentrations used for challenge and rechallenge dosing were selected based on the results of range-finding experimentation in the Primary Irritation Phase.)
A Positive Control Group of three male and three female guinea pigs was included to demonstrate the reliability of the test system. The Positive Control Group was induced and challenged on a similar regimen as the Test Group with dinitrochlorobenzene (DNCB) as the positive control material.
Naive Control I and II Groups of three male and three female guinea pigs each were dosed only at challenge and rechallenge, respectively, in the same manner as the Test Group and served as irritation controls.
Reactions to challenge and rechallenge dosing were evaluated at approximately 24 and 48 hours after completion of exposure. Body weights and clinical observations were recorded just prior to study initiation and at termination.
There were no other deaths, than the one male in the control group, which had died because of a mechanical accident. There were no calcium sulfonate test substance related clinical findings or body weight changes.
Based on the Sensitisation Incidence Index of 83%, the positive control material, DNCB, was found to be an extreme sensitizing agent in the albino guinea pig under the conditions of this study thereby demonstrating the reliability of the test system. There were no sensitisation reactions in the Test Group following challenge and rechallenge dosing. The sensitisation Incidence Index was calculated to be 0% for the Test Group. Based on these results, the test material, the calcium sulfonate CAS 61789 -86 -4, was found to be nonsensitizing in albino guinea pigs under the conditions of this study.
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