Reaction products of benzenesulfonic acid, mono-C20-24 (even)-sec-alkyl derivs. para-, calcium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 23 June 1993 and 30 July 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: no guideline stated

Deviations:

no

Principles of method if other than guideline:

To determine the irritation and/or sensitization potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 003

Cas Number:

61789-86-4

Test material form:

liquid: viscous

Details on test material:

Description: Brown viscous liquid
Date recieved: February 22, 1993

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

Fifty-three (53) subjects, 8 males and 45 females, ranging in age from 18 to 65 years were empaneled for this test.
The subjects were informed of the nature of the test, including possible adverse reactions.
Written informed consent was obtained.
Additionally, the subjects were considered dependable and able to read and understand instructions. The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article.

Clinical history:

The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article.

Route of administration:

dermal

Details on study design:

Induction Phase
The Induction Phase was initiated on: June 23, 1993.
Approximately 0.2 mL of the test article was placed directly onto a Parke-Davis ReadiBandage occlusive patch, which was applied to the back of each subject, between the scapulae and waist, adjacent to the spinal mid-line.
The subjects were instructed to remove the patch 24-hours after application. Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48-hour rest periods followed each Saturday removal. The site was scored by a trained examiner just prior to the next patch application. This procedure was repeated every Monday, Wednesday and Friday until nine (9) applications of the test article had been made.
Procedurally, if a subject developed a positive reaction of a 2-level erythema or greater during the Induction phase or, at the discretion of the Study Director, if the skin response warranted a change in site, the patch would be applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or greater) occurred at the new site, no further applications would be made. However, any reactive subjects would be subsequently Challenge patch tested.

Challenge Phase
After a rest period of approximately two weeks (no applications of the test article), the Challenge patch was applied to a previously unpatched (virgin) test site. The site was scored 24 and 72-hours after application. All subjects were instructed to report any delayed skin reactivity which might have occurred after the final Challenge patch reading. When warranted, selected test subjects were called back to the Clinic for additional examinations and scoring to determine possible increases or decreases in Challenge patch reactivity.
The final Challenge patch reading was made on: July 30, 1993.

Results and discussion

Results of examinations:

Fifty-one (51) subjects satisfactorily completed the test procedure. Two (2/53) subjects discontinued for personal reasons unrelated to the conduct of the study. Discontinued panellist data are shown up to the point of discontinuation, but are not used in the Results, Discussion or Conclusions sections of this final report.
Transient, barely perceptible (+) non-specific patch test responses were observed on 2/51 test panellists (Subject nos. 27 and 48) during the Induction phase of the study. None of these non-specific responses was considered to be irritant or allergic in nature.

Any other information on results incl. tables

TABLE 1 - Individual Scores
Panel No: 93089
Repeated Insult Patch Test - Occlusive
Test Article: Calcium sulfonate (@ 10% in Mineral Oil)
Subj. No.	Induction									Challenge Virgin Site
	Exposure Number
	1	2	3	4	5	6	7	8	9	24hr	72hr
1	0	0	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0	0	0
5	0	0	0	0	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0	0	0
8	0	0	0	0	0	0	0	0	0	0	0
9	0	0	0	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0	0	0	0
11	0	0	0	0	0	0	0	0	0	0	0
12	0	0	0	0	0	0	0	0	0	0	0
13	0	0	0	0	0	0	0	0	0	0	0
14	0	0	0	0	0	0	0	0	0	0	0
15	0	0	0	0	0	0	0	0	0	0	0
16	0	0	0	0	0	0	0	0	0	0	0
17	0	0	0	0	0	0	0	0	0	0	0
18	0	0	0	0	0	0	0	0	0	0	0
19	0	0	0	0	0	0	0	0	0	0	0
20	0	0	0	0	0	0	0	0	0	0	0
21	0	0	0	0	0	0	0	0	0	0	0
22	0	0	0	0	0	0	0	0	0	0	0
23	0	0	0	0	0	0	0	0	0	0	0
24	0	0	Discontinued.
25	Discontinued
26	0	0	0	0	0	0	0	0	0	0	0
27	0	0	0	+	+	0	0	+	+	0	0
28	0	0	0	0	0	0	0	0	0	0	0
29	0	0	0	0	0	0	0	0	0	0	0
30	0	0	0	0	0	0	0	0	0	0	0
31	0	0	0	0	0	0	0	0	0	0	0
32	0	0	0	0	0	0	0	0	0	0	0
33	0	0	0	0	0	0	0	0	0	0	0
34	0	0	0	0	0	0	0	0	0	0	0
35	0	0	0	0	0	0	0	0	0	0	0
36	0	0	0	0	0	0	0	0	0	0	0
37	0	0	0	0	0	0	0	0	0	0	0
38	0	0	0	0	0	0	0	0	0	0	0
39	0	0	0	0	0	0	0	0	0	0	0
40	0	0	0	0	0	0	0	0	0	0	0
41	0	0	0	0	0	0	0	0	0	0	0
42	0	0	0	0	0	0	0	0	0	0	0
43	0	0	0	0	0	0	0	0	0	0	0
44	0	0	0	0	0	0	0	0	0	0	0
45	0	0	0	0	0	0	0	0	0	0	0
46	0	0	0	0	0	0	0	0	0	0	0
47	0	0	0	0	0	0	0	0	0	0	0
48	0	0	0	0	0	0	+	0	0	0	0
49	0	0	0	0	0	0	0	0	0	0	0
50	0	0	0	0	0	0	0	0	0	0	0
51	0	0	0	0	0	0	0	0	0	0	0
52	0	0	0	0	0	0	0	0	0	0	0
53	0	0	0	0	0	0	0	0	0	0	0
Scale:	0 =	No evidence of any effect
	+ =	Barely Perceptible (Minimal, faint, uniform or spotty erythema)
	1 =	Mild (Pink, uniform erythema covering most of the contact site
	2 =	Moderate (Pink-red erythema uniform in the entire contact site)
	3 =	Marked (Bright-red erythema with/without petechiae or papules)
	4 =	Severe (Deep-red erythema with/without vesiculation or weeping)

Applicant's summary and conclusion

Conclusions:

Under the conditions of a repeated insult (occlusive) patch test procedure, the test Article: Calcium sulfonate (0.2ml, 10% in Mineral Oil) (Total Base Number = 400) did not induce irritant or allergic contact dermatitis in human subjects.

Executive summary:

To determine the irritation and/or sensitization potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel).

Fifty-three (53) subjects, 8 males and 45 females, ranging in age from 18 to 65 years were empaneled for this test.

The 9 Repeated Insult (occlusive) Patch Test (9 RIPT) was conducted. Fifty-one (51) subjects satisfactorily completed the test procedure. Two (2/53) subjects discontinued for personal reasons unrelated to the conduct of the study. Transient, barely perceptible (+) non-specific patch test responses were seen in two subjects. None of these non-specific responses were considered to be irritant or allergic in nature.

Under the conditions of a repeated insult (occlusive) patch test procedure, the test Article: Calcium sulfonate ( 0.2ml, 10% in Mineral Oil) (Total Base Number = 400) did not induce irritant or allergic contact dermatitis in human subjects.