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Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
Between 04 March 1993 and 26 March 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study conducted in accordance with generally accepted scientific principles 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: Sulfonic acid, petroleum, calcium salt 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 study / information:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Total Base Number (TBN) = 300

Method

Ethical approval:
confirmed and informed consent free of coercion received
Details on study design:
The 48-Hour Patch Test was conducted to determine comparative dermal irritation to determine tolerability for subsequent human patch testing as follows:
Panel No: 93030
The study was initiated on March 4,1993 and observations (skin reactivity) were made on March 6, 1993 (48-hours) and March 8, 1993 (96-hours).
Panel No: 93037
The study was initiated on March 22,1993 and observations (skin reactivity) were made on March
24, 1993 (48-hours) and March 26, 1993 (96-hours).
Approximately 0.2 mL of each test article was placed onto Parke-Davis Readi-Bandage occlusive patches. The patch test units were applied to the back of each subject for a period of 48-hours.
At the end of the 48-hour contact period, the patch test units were removed at the Clinic and scored for dermal reactivity. A second reading was taken 48-hours later (96-hour post-application).

Dermal responses were recorded using the following 6-point 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)
All other observed dermal sequelae (Le. oedema, dryness, hypo- or hyperpigmentation, etc.) were appropriately recorded and described as mild, moderate or severe.
Exposure assessment:
measured
Details on exposure:
Panel No: 93030
Twenty-seven (27) subjects, 8 males and 19 females, ranging in age from 18 to 67 years, were empaneled to test 1%, 3%, and 10% concentrations of the test articles, including 2 controls.
Panel No: 93037
Twenty-eight (28) subjects, 7 males and 21 females, ranging in age from 18 to 58 years, were empaneled to test 30% and 100% (Neat) concentrations of the test articles, without the controls.
The subjects were informed of the nature of the tests, 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 conditions which would have precluded application of the test articles.

The subjects did not exhibit any physical or dermatological conditions which would have precluded application of the test articles.

Results and discussion

Results:
A total of 27/27 subjects satisfactorily completed the test procedure for Panel no. 93030. A total of 28/28 subjects satisfactorily completed the test procedure for Panel no. 93037. There were no discontinued panelists at any time during the come of the studies.

None of the patch test reactivity observed was considered to be evidence of allergic contact sensitisation. All were considered indicative of irritation.
Peak levels of dermal irritation were observed at the 48-hour reading (i.e., following removal of the patch). By the 96-hour reading, overall levels and seventy of reactivity were generally diminished.
Student-Newman-Keuls post-hoc analyses showed the following significant (P 5.05) differences in mean irritation scores observed among all the concentrations tested.
Under the conditions of a 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles based on comparative mean irritation scores was observed: Calcium sulfonate C15-36 TBN=13 >= Calcium sulfonate TBN=13 >=Calcium sulfonate TBN=30 > Non-sulfonate substance >= Calcium sulfonate TBN=300 (EC# 263-093-9) = Calcium sulfonate TBN=300 = mineral oil = mineral oil.
Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitisation in human subjects.

Any other information on results incl. tables

Table 1
Individual Test Subject Irritation Scores
Test Article: Calcium sulfonate TBN=13
48 hours 96 hours
       
Subj. No Test concentration Panel 93030 Panel 93037 Panel 93030 Panel 93037
1% 3% 10% 30% 100% 1% 3% 10% 30% 100%
1 0 0 0 0 3 0 0 0 0 2s
2 0 + 0 0 0 0 + 0 0 0
3 0 0 + 3 3 0 0 + + 1
4 0 0 + 0 0 0 0 + 0 0
5 0 0 1 0 3 0 0 1 0 1
6 0 0 + 0 0 0 0 0 0 0
7 0 0 0 2 3 0 0 0 + 2
8 0 0 + 0 3 0 0 + 0 1
9 0 0 0 0 2 0 0 0 0 1
10 0 0 1 0 2 0 0 + 0 1
11 0 0 0 1 2 0 0 + + 2
12 0 0 + 0 0 0 0 0 0 2
13 0 0 + 0 2 0 0 0 0 1
14 + + + 1 3 0 0 0 1 3
15 0 0 0 0 0 0 0 0 0 0
16 0 0 0 0 0 0 0 0 0 0
17 0 0 + 0 2 0 0 + 0 1
18 0 0 0 2 3 0 0 0 2 3
19 0 0 0 2 3 0 0 0 2 3s
20 0 0 0 + 2 0 0 0 0 1
21 0 0 0 0 3 0 0 0 0 3s
22 0 0 0 3 3 0 0 0 2 2
23 0 0 0 2 2 0 0 0 2 2
24 0 0 + 2 2 0 0 0 2 2
25 0 0 + 0 3 0* 0*  +* 0 3
26 0 0 0 0 2 0 0 0 0 2s
27 0 0 0 0 2 0 0 0 0 1
28 - - - 2 2 - - - 1 1
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}
 * = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours s = scabbing
 - = 27 subjects were empanelled for Panel No. 93030
 - = 28 subjects were empanelled for Panel No. 93037

Table 2
Individual Test Subject Irritation Scores
Test Article: Calcium sulfonate C15-36 TBN=13
48 hours 96 hours
       
Subj. No Test concentration Panel 93030 Panel 93037 Panel 93030 Panel 93037
1% 3% 10% 30% 100% 1% 3% 10% 30% 100%
1 0 0 0 1 3 0 0 0 + 1s
2 0 0 0 0 3 0 + 0 0 0
3 0 0 + + 2 0 0 0 + +
4 0 0 0 0 3 0 0 0 0 3
5 0 0 + 0 3 0 0 + 0 2
6 0 0 + 0 0 0 0 0 0 0
7 0 0 + 0 3 0 0 0 0 2
8 0 0 0 + 3 0 0 0 0 3s
9 0 0 0 1 2 0 0 0 1 2
10 0 0 1 0 3 0 0 + 0 3
11 0 0 0 0 3 0 0 + 0 3
12 0 0 + 0 3 0 0 0 0 2
13 0 0 0 0 3 0 0 0 0 3s
14 0 0 + 1 3 0 0 0 1 2
15 0 0 + 0 0 0 0 0 0 0
16 0 0 0 0 0 0 0 0 0 0
17 0 0 + 0 3 0 0 0 0 3s
18 0 0 0 2 3 0 0 0 1 2
19 0 0 0 1 3 0 0 0 + 3s
20 0 0 0 0 2 0 0 0 0 2
21 0 0 1e 0 3 0 0 + 0 3s
22 0 + 0 2 3 0 0 0 + 3
23 0 0 0 0 3 0 0 0 0 2
24 0 0 0 1 3 0 0 0 + 2
25 0 0 0 2 + 0* 0* 0* 3s +
26 0 0 0 2 + 0 0 0 2s 0
27 0 0 0 0 3 0 0 0 0 2
28 - - - 0 3 - - - 0 3
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}
 * = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours s = scabbing
 - = 27 subjects were empanelled for Panel No. 93030
 - = 28 subjects were empanelled for Panel No. 93037

Table 3
Individual Test Subject Irritation Scores
Test Article: Calcium sulfonate TBN=300
48 hours 96 hours
       
Subj. No Test concentration Panel 93030 Panel 93037 Panel 93030 Panel 93037
1% 3% 10% 30% 100% 1% 3% 10% 30% 100%
1 0 0 0 0 0 0 0 0 0 0
2 0 0 + 0 0 0 0 + 0 0
3 0 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0 0 0 0
6 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
9 0 0 0 0 0 0 0 0 0 0
10 0 0 0 0 0 0 0 0 0 0
11 0 0 0 0 0 0 0 0 0 0
12 0 0 0 0 0 0 0 0 0 0
13 0 0 0 0 0 0 0 0 0 0
14 + 0 0 0 0 0 0 0 0 0
15 + 0 0 0 0 0 0 0 0 0
16 0 0 0 0 0 0 0 0 0 0
17 0 0 0 0 0 0 0 0 0 0
18 0 0 0 0 0 0 0 0 0 0
19 0 0 0 0 0 0 0 0 0 0
20 0 0 0 0 0 0 0 0 0 0
21 0 0 0 0 0 0 0 0 0 0
22 0 0 0 0 0 0 0 0 0 0
23 0 0 + 0 0 0 0 0 0 0
24 0 0 0 0 0 0 0 0 0 0
25 0 0 0 0 0 0* 0* 0* 0 0
26 0 0 0 0 0 0 0 0 0 0
27 0 0 0 0 0 0 0 0 0 0
28 - - - 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}
 * = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours
 - = 27 subjects were empanelled for Panel No. 93030
  = 28 subjects were empanelled for Panel No. 93037

Table 4
Individual Test Subject Irritation Scores
Test Article: Calcium sulfonate TBN=30
48 hours 96 hours
       
Subj. No Test concentration Panel 93030 Panel 93037 Panel 93030 Panel 93037
1% 3% 10% 30% 100% 1% 3% 10% 30% 100%
1 0 0 0 0 0 0 0 0 0 0
2 0 0 1 0 0 + + + 0 0
3 0 + 0 3 3 0 0 0 1 2
4 0 0 0 0 0 0 0 0 0 0
5 0 0 1 0 + 0 0 + 0 +
6 0 0 0 0 0 0 0 0 0 0
7 0 0 + 2 3 0 0 0 2s 2s
8 0 0 0 0 3 0 0 0 0 3s
9 0 0 0 0 2 0 0 0 0 1
10 0 0 0 1 1 0 0 0 1 1
11 0 0 0 2 3 0 0 0 1 2
12 0 0 1 2 3 0 0 + 1 2
13 0 0 0 0 2 0 0 0 0 +
14 0 0 + 1 3 0 0 0 0 3
15 0 0 + 0 0 0 0 0 0 0
16 0 0 + 0 0 0 0 + 0 0
17 0 + + 0 3 0 0 0 0 3s
18 0 0 0 2 3 0 0 0 1 2
19 0 0 0 3 3 0 0 0 3s 3s
20 0 0 0 1 1 0 0 0 + +
21 0 0 0 2 3 0 0 0 2 3s
22 0 0 0 3 3 0 0 0 3s 3s
23 0 0 + 0 + 0 0 + 0 0
24 0 0 0 0 1 0 0 0 0 0
25 0 0 + 1 2 0* 0* 0* + +
26 0 0 + 0 0 0 0 0 0 0
27 0 0 0 0 1 0 0 0 0 +
28 - - - 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}
 * = Subject No. 25 missed the 96-hour reading: Reading was taken at 120-hours
 - = 27 subjects were empanelled for Panel No. 93030
  = 28 subjects were empanelled for Panel No. 93037

Table 5
Individual Test Subject Irritation Scores
Test Article: Calcium sulfonate TBN=300 (EC 263-093-9)
48 hours 96 hours
       
Subj. No Test concentration Panel 93030 Panel 93037 Panel 93030 Panel 93037
1% 3% 10% 30% 100% 1% 3% 10% 30% 100%
1 0 0 0 3 0 0 0 0 2s 0
2 0 0 0 0 0 0 0 0 0 0
3 0 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0 0
5 0 0 0 0 0 0 0 0 0 0
6 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
9 0 0 0 0 + 0 0 0 0 0
10 0 0 0 0 0 0 0 0 0 0
11 0 0 0 0 0 0 0 0 0 0
12 0 0 0 0 0 0 0 0 0 0
13 0 0 0 0 0 0 0 0 0 0
14 + 0 0 0 0 0 0 0 0 0
15 0 0 0 0 0 0 0 0 0 0
16 0 0 0 0 0 0 0 0 0 0
17 0 0 0 0 0 0 0 0 0 0
18 0 0 0 0 0 0 0 0 0 0
19 0 0 0 0 0 0 0 0 0 0
20 0 0 0 0 0 0 0 0 0 0
21 0 0 0 0 0 0 0 0 0 0
22 0 0 0 0 0 0 0 0 0 0
23 0 0 0 0 0 0 0 0 0 0
24 0 0 0 0 0 0 0 0 0 0
25 0 0 0 0 0 0* 0* 0* 0 0
26 0 0 0 0 0 0 0 0 0 0
27 0 0 0 0 0 0 0 0 0 0
28 - - - 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}
 * = Subject No. 25 missed the 96-hour readiung: Reading was taken at 120-hours s = scabbing
 - = 27 subjects were empanelled for Panel No. 93030
  = 28 subjects were empanelled for Panel No. 93037

Table 6
Individual Test Subject Irritation Scores
Test Article: Non-sulfonate substance
48 hours 96 hours
       
Subj. No Test concentration Panel 93030 Panel 93037 Panel 93030 Panel 93037
1% 3% 10% 30% 100% 1% 3% 10% 30% 100%
1 0 0 0 0 0 0 0 0 0 1s
2 0 + 1 0 0 0 + + 0 0
3 0 0 0 0 0 0 0 0 + +
4 0 0 0 0 0 0 0 0 0 0
5 0 0 + + + 0 0 + 0 0
6 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
9 0 0 0 + + 0 0 0 0 0
10 0 0 0 0 0 0 0 0 0 0
11 0 0 0 0 0 0 0 0 0 0
12 0 0 + 0 0 0 0 0 0 0
13 0 0 0 0 0 0 0 0 0 0
14 + + + 0 0 0 0 0 0 0
15 + 0 0 0 0 0 0 0 0 0
16 0 0 0 0 0 0 0 0 0 0
17 0 0 0 0 + 0 0 0 0 0
18 + + + + + + + + 0 0
19 0 0 0 0 0 0 0 0 0 0
20 0 0 0 0 0 0 0 0 0 0
21 0 0 0 + 1 0 0 0 + 1
22 0 0 0 0 2 0 0 0 1 1
23 0 0 0 0 + 0 0 0 0 +
24 0 0 0 0 0 0 0 0 0 0
25 + 0 0 0 + 0* 0* 0* 0 0
26 0 0 0 0 0 0 0 0 0 0
27 0 0 0 0 0 0 0 0 0 0
28 - - - 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}
 * = Subject No. 25 missed the 96-hour readiung: Reading was taken at 120-hours s = scabbing
 - = 27 subjects were empanelled for Panel No. 93030
  = 28 subjects were empanelled for Panel No. 93037

TABLE 7
Panel No: 93030
Individual Test Subject Irritation Scores
Test Article: Mineral Oil
Subject No. 48 hours 96 hours
Neat Neat
1 0 0
2 0 0
3 0 0
4 0 0
5 + +
6 0 0
7 0 0
8 0 0
9 0 0
10 0 0
11 0 0
12 0 0
13 0 0
14 0 0
15 0 0
16 0 0
17 0 0
18 0 0
19 0 0
20 0 0
21 0 0
22 0 0
23 0 0
24 0 0
25 +  +(120h=0)
26 0 0
27 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}   
 * = missed visit, no reading taken   

TABLE 8
Panel No: 93030
Individual Test Subject Irritation Scores
Test Article: Mineral Oil
Subject No. 48 hours 96 hours
Neat Neat
1 0 0
2 0 0
3 0 0
4 0 0
5 0 0
6 0 0
7 0 0
8 0 0
9 0 0
10 0 0
11 0 0
12 + 0
13 0 0
14 0 0
15 + 0
16 0 0
17 0 0
18 0 0
19 0 0
20 0 0
21 0 0
22 0 0
23 0 0
24 0 0
25 0 0
26 0 0
27 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 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles based on comparative mean irritation scores was observed: Calcium sulfonate C15-36 TBN=13 >= Calcium sulfonate TBN=13 >= Calcium sulfonate TBN=30 > Non-sulfonate substance >= Calcium sulfonate TBN=300 (EC 263-093-9) = Calcium sulfonate TBN=300 = Mineral oil = Mineral oil.

Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitization in human subjects.
Executive summary:

To determine and compare the relative primary irritation potential and estimate tolerability for subsequent occlusive RIPT studies of eight (8) test articles when applied to the skin of human subjects for 48-hours under occlusive patches.

Under the conditions of a 48-hour (occlusive) patch test, the following overall (general) ranking of the test articles based on mean irritation scores was observed: Calcium sulfonate C15-36 TBN=13 >= Calcium sulfonate TBN=13 >= Calcium sulfonate TBN=30 > Non-sulfonate substance >= Calcium sulfonate TBN=300 (EC 263-093-9) = Calcium sulfonate TBN=300 = Mineral oil = Mineral oil.

Based on these data, test concentrations of 10% or less are considered to be appropriate and probably tolerable for subsequent repeated insult (occlusive) patch testing (RIFT) for the estimation of potential induced allergic contact sensitization in human subjects.