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Sensitisation data (human)

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Endpoint:
sensitisation data (humans)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
Between 10 March 1993 and 21 April 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Good clinical practices (GCP) statement; uses one of a number of acceptable methods but criteria for subject selection was not described.
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH
1. HYPOTHESIS FOR THE CATEGORY APPROACH
The read across follows Scenario 5 - Qualitatively and quantitatively similar effects are caused by a common compound, which is formed from all category members (as described in the 2017 Read-Across Assessment Framework document).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
TARGET: Benzene, tetrapropylene-, distn. residues, sulfonated, sodium salts
SOURCE: Benzene, polypropene derivs., sulfonated, calcium salts
3. CATEGORY APPROACH JUSTIFICATION
Linear and non-linear or branched alkylbenzene sulfonates are anionic surfactants with molecules characterized by a hydrophobic (apolar) and a hydrophilic (polar) group. As a group of chemicals, they are generally mixtures of closely related isomers and homologues. Each molecule contains an aromatic ring sulfonated at the para position and attached to either a linear or a branched alkyl chain at any position except the terminal carbons. The sulfonate group is a common functional group present in each of the category members, and is expected to exhibit similar biological activities with little influence from the length of carbon chain. The cation components of the chemicals (e.g. calcium, magnesium, sodium, or barium) are not expected to contribute significantly to the toxicity.
4. DATA MATRIX
See Read Across document attached to CSR

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:
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 (nonexclusive panels).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Description - Dark Brown Viscous Liquid*
*Tested @ 1 % in white mineral oil

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
Fifty-three (53) subjects, 8 males and 5 females, ranging in age from 18 to 70 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.
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:
The 9 Repeated Insult (occlusive) Patch Test (9 RIPT) was conducted as follows:

Induction Phase
The Induction Phase was initiated on: March 10, 1993.
Approximately 0.2 mL of the test article was placed onto a Parke-Davis Readi-Bandage 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 develops 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 warrants 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 2 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: April 21, 1993.

Results and discussion

Results of examinations:
Test Article: Calcium sulfonate (@1% in Mineral oil)
Forty-nine (49) subjects satisfactorily completed the test procedure. Four (4/53) subjects discontinued for personal reasons unrelated to the conduct of the study. Discontinued panelist 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 2/49 test panelists (Subject nos. 7, 43) 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: 95027
Repeated Insult Patch Test - Occlusive
Test Article: Calcium sulfonate (@ 1% in Mineral Oil)
Subj. No. Induction Challenge
Virgin Site
Exposure Number
1 2 3 4 5 6 7 8 9 24 hr 72 hr
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
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 Discontinued
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 Discontinued
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 0 0 0 0 0 Discontinued
25 0 0 0 0 0 0 0 0 0 0 0
26 0 0 0 0 0 0 0 0 0 0 0
27 0 0 0 0 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 Discontinued
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 Discontinued
47 0 0 0 0 0 0 0 0 0 0 0
48 0 0 0 0 0 0 0 0 0 0 * (192 h = 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 petechiaeorpapules)
4 = Severe (Deep-red erythema with/without vesiculation or weeping)
* = missed visit; no reading taken

Applicant's summary and conclusion

Conclusions:
Under the conditions of a repeated insult (occlusive) patch test procedure, Test Article: Calcium sulfonate (@1% in Mineral Oil) (Total Base Number = 300) did not induce irritant or allergic contact dennatitis in human subjects.
Executive summary:

Fifty-three (53) subjects, 8 males and 5 females, ranging in age from 18 to 70 years were empaneled for this test.

Approximately 0.2 mL of the test article was placed onto a Parke-Davis Readi-Bandage 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. This procedure was repeated every Monday, Wednesday and Friday until nine (9) applications of the test article had been made.

After a rest period of approximately 2 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.

Under the conditions of a repeated insult (occlusive) patch test procedure, the test article: Calcium sulfonate (@1% in Mineral Oil) (Total Base Number = 300) did not induce irritant or allergic contact dematitis in human subjects.