Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 25 April 1994 and 29 April 1994

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:

1994

Report date:

1994

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 and compare the relative primary irritation potential and estimate tolerability for subsequent occlusive RIFT studies of two (2) calcium sulfonate test articles when applied to the skin of human subjects for 48-hours under occlusive patches.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 002

Cas Number:

61789-86-4

Details on test material:

Description: Brown viscous liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

Twenty-seven (27) subjects, 4 males and 23 females, ranging in age from 19 to 61 years, were empaneled to test 1%, 3%, 10% and 30% concentrations of the calcium sulfonate test articles.
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 conditions which would have precluded application of the calcium sulfonate test articles.

Clinical history:

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

Route of administration:

dermal

Details on study design:

The 48-Hour Patch Test was conducted as follows:
The study was initiated on April 25, 1994 and observations (skin reactivity) were made on April 27, 1994 (48-hours) and April 29, 1994 (96-hours).
Approximately 0.2 mL of each calcium sulfonate 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-hours post-application).

Results and discussion

Results of examinations:

Test Articles: Calcium sulfonates
Twenty-seven (27) subjects satisfactorily completed Panel No. 94042. There were no discontinued subjects.
The calcium sulfonate test Article Calcium sulfonate (Total Base Number = 100) exhibited negligible dermal irritancy at all four test concentrations, following 48 hours of occlusive patch testing.
The calcium sulfonate test Article Calcium sulfonates (Total Base Number = 82) exhibited negligible dermal irritancy at 1 % and 3%, very mild irritation at 10% and marked to severe irritation at the 30% concentration, following 48 hours of occlusive patch testing.
For the purpose of repeated insult (occlusive) patch testing (RIPT), test concentrations of 30% for Calcium sulfonate (TBN = 100) and 3% for Calcium sulfonate (TBN = 82) are estimated to be tolerable for a human test population.
For the purpose of repeated insult (semi-occlusive) patch testing, test concentrations of 10% for either calcium sulfonate test article are estimated to be tolerable for a human test population.

Any other information on results incl. tables

The following summarizes the Mean Irritation Scores observed for each of the calcium sulfonate test articles at the various concentrations tested:

Test Article Calcium sulfonate (TBN = 100)

48-hours

1%       3%       10%       30%

0.02     0.02      0.02       0.04

96 -hours

1%       3%       10%       30%

0.00       0.00        0.00        0.00

Test Article Calcium sulfonate (TBN = 82)

48-hours

1%      3%      10%      30%

0.02    0.02     0.13      1.26

96 -hours

1%      3%      10%      30%

0.00      0.00      0.04        0.59

TABLE 1
Individual Test Subject Irritation Scores
Test Article: Calcium sulfonate (TBN = 82)
Subject No.		48-Hours				96-Hours
		Test Concentration
		1%	3%	10%	30%	1%	3%	10%	30%
1		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
4		0	0	0	0	0	0	0	0
5		0	0	0	0	0	0	0	0
6		0	0	0	0	0	0	0	0
7		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		0	0	0	0	0	0	0	0
11		0	0	0	+	0	0	0	0
12		0	0	0	0	0	0	0	0
13		+	+	+	+	0	0	0	0
14		0	0	0	0	0	0	0	0
15		0	0	0	0	0	0	0	0
16		0	0	0	0	0	0	0	0
17		0	0	0	0	0	0	0	0
18		0	0	0	0	0	0	0	0
19		0	0	0	0	0	0	0	0
20		0	0	0	0	0	0	0	0
21		0	0	0	0	0	0	0	0
22		0	0	0	0	0	0	0	0
23		0	0	0	0	0	0	0	0
24		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
27		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)

TABLE 2
Individual Test Subject Irritation Scores
Test Article: Calcium sulfonate (TBN = 100)
Subject No.		48-Hours				96-Hours
		Test Concentration
		1%	3%	10%	30%	1%	3%	10%	30%
1		0	0	+	2	0	0	0	1d
2		0	0	0	0	0	0	0	0
3		0	0	0	+	0	0	0	0
4		0	0	0	0	0	0	0	0
5		0	0	+	2	0	0	0	+d
6		0	0	0	2e	0	0	0	+d
7		0	0	1	3ev	0	0	+	1d
8		0	0	0	2	0	0	0	+d
9		0	0	0	+	0	0	0	+
0		0	0	0	0	0	0	0	0
11		0	0	0	2e	0	0	0	1
12		0	0	0	2	0	0	0	1d
13		+	+	+	4vw	0	0	0	3d
14		0	0	0	+p	0	0	0	+
15		0	0	0	+	0	0	0	+
16		0	0	+	1	0	0	0	0
17		0	0	0	2	0	0	0	0d
18		0	0	0	1	0	0	0	1
19		0	0	0	0	0	0	0	0
20		0	0	+	2	0	0	0	1d
21		0	0	0	+	0	0	0	0
22		0	0	0	+	0	0	+*	1**
23		0	0	0	+	0	0	0	1pd
24		0	0	0	3	0	0	0	1d
25		0	0	0	1e	0	0	0	+
26		0	0	0	1e	0	0	0	0
27		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)
	e =	Mild to moderate oedema
	p =	mild papular reaction
	w =	weeping
	d =	mild to moderate dryness
	* =	(168 hr = 0)
	v =	moderate vesiculation
	** =	(168 hr = +d)

Applicant's summary and conclusion

Conclusions:

The calcium sulfonate test Article Calcium sulfonate (Total Base Number = 100) exhibited negligible dermal irritancy at all four test concentrations, following 48 hours of occlusive patch testing.
The calcium sulfonate test Article Calcium sulfonate (Total Base Number = 82) exhibited negligible dermal irritancy at 1 % and 3%, very mild irritation at 10% and marked to severe irritation at the 30% concentration, following 48 hours of occlusive patch testing.
For the purpose of repeated insult (occlusive) patch testing (RIPT), test concentrations of 30% for Calcium sulfonate (TBN = 100= and 3% for Calcium sulfonate (TBN = 82) are estimated to be tolerable for a human test population.
For the purpose of repeated insult (semi-occlusive) patch testing, test concentrations of 10% for either calcium sulfonate test article are estimated to be tolerable for a human test population.

Executive summary:

To determine and compare the relative primary irritation potential and estimate tolerability for subsequent occlusive RIFT studies of two (2) calcium sulfonate test articles when applied to the skin of human subjects for 48-hours under occlusive patches.

Twenty-seven (27) subjects, 4 males and 23 females, ranging in age from 19 to 61 years, were empaneled to test 1%, 3%, 10% and 30% concentrations of the calcium sulfonate test articles. The 48-Hour Patch Test was conducted.

Test Article Calcium sulfonate (Total Base Number = 100) exhibited negligible dermal irritancy at all four test concentrations, following 48 hours of occlusive patch testing.

Test Article Calcium sulfonate (Total Base Number = 82) exhibited negligible dermal irritancy at 1 % and 3%, very mild irritation at 10% and marked to severe irritation at the 30% concentration, following 48 hours of occlusive patch testing.

For the purpose of repeated insult (occlusive) patch testing (RIPT), test concentrations of 30% for Calcium sulfonate (TBN = 100) and 3% for Calcium sulfonate (TBN = 82) are estimated to be tolerable for a human test population.

For the purpose of repeated insult (semi-occlusive) patch testing, test concentrations of 10% for either calcium sulfonate test article are estimated to be tolerable for a human test population.