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Toxicological information

Skin sensitisation

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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:
1992
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

Constituent 1
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.

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.