Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Tested in human subjects

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Principles of method if other than guideline:

A primary skin irritation was carried out on human subjects.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

26550-05-5

IUPAC Name:

26550-05-5

Details on test material:

- Name of test material (as cited in study report): SBU 185, VARSULF SBU-185
- Substance type: Sulfosuccinate (tensio-active)
- Physical state: Pale, yellow liquid
- Analytical purity: 50% (active ingredient VARSULF SBU-185)
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: Sample A : SC-154-52A; Sample B: SC-154-52B
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals

Species:

human

Strain:

not specified

Details on test animals or test system and environmental conditions:

Not applicable

Test system

Type of coverage:

semiocclusive

Vehicle:

other: distilled water

Controls:

other: Sample B did not contain Varsulf SBU-185

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): 10% v/v of Sample A and Sample B

Duration of treatment / exposure:

3 times 24 hours

Observation period:

24 hours (after last application)

Number of animals:

12

Details on study design:

TEST SITE
- Area of exposure: outer aspect of the right upper arm
- % coverage: no data
- Type of patch: Parke, Davis Readi Band patches

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the sites were cleansed with clear water and then the skin was dried with a soft paper towel
- Time after start of exposure: 24 hours

SCORING SYSTEM:
0 No evidence of irritation
1 Minimal erythema, barely perceptible
2 Definite erythema, readily visible; or minimal edema; or minimal popular response
3 Erythema and papules
4 Definite erythema
5 Erythema, edema and papules
6 Vesicular eruption
7 Strong reaction spreading beyond test site

A Slight glazed appearance
B Marked glazing
C Glazing with pealing and cracking
F Glazing with fissures
G Film of dried serous exudate covering all or portion of the patch site
H Small petechial erosions and/or scabs

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

Application 1 15 min.

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

7

Reversibility:

not specified

Remarks on result:

other: Sample A

Results 2

Irritation parameter:

overall irritation score

Remarks:

Application 2 15 min.

Basis:

mean

Time point:

48 h

Score:

0.18

Max. score:

7

Reversibility:

not specified

Remarks on result:

other: Sample A

Results 3

Irritation parameter:

overall irritation score

Remarks:

Application 3 15 min.

Basis:

mean

Time point:

72 h

Score:

0.25

Max. score:

7

Reversibility:

not specified

Remarks on result:

other: Sample A

Results 4

Irritation parameter:

overall irritation score

Remarks:

Application 3 24h

Basis:

mean

Time point:

other: 96 h

Score:

0.42

Max. score:

7

Reversibility:

not specified

Remarks on result:

other: Sample A

Any other information on results incl. tables

Table1. Table of Results of Skin Irritation Scores

 

Sample A (SC-154-52A)

Panelist Number	Application 1 15 Min.*	Application 2 15 Min.*	Application 3 15 Min.*                    24 Hours*
1	0	0	0	0
2	0	0	0	0
3	L	L	0	0
4	0	0	0	0
5	0	0	0	0
6	0	0	0	0
7	0	0	0	1A
8	0	0	0	0
9	0	1A	1A	1A
10	0	0	0	0
11	0	1A	1A	1A
12	0	0	1A	2B

 

Sample B (SC-154-52B) not containing Varsulf SBU-185

Panelist Number	Application 1 15 Min.*	Application 2 15 Min.*	Application 3 15 Min.*                    24 Hours*
1	0	0	0	0
2	0	0	0	0
3	L	L	0	0
4	0	0	0	0
5	0	0	0	0
6	0	0	0	0
7	0	1A	1A	1A
8	0	0	0	0
9	0	1A	1A	1A
10	0	0	0	0
11	0	1A	1A	1A
12	0	0	1A	2B

*Time after removal of patches.

L= Lost Patch

A= Slight glazed appearance

B= Marked glazing

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

A 10% v/v aqueous solution of both samples was slightly irritating to the skin, under the conditions of this experiment.

Executive summary:

A primary skin irritation was carried out on 12 female subjects with Sample A (SC-154-52A)(containing 10% VARSULF SBU-185; 50% active) and Sample B (SC-154-52B)(containing 0% VARSULF SBU-185). Both samples were diluted to 10% v/v with distilled water. Each subject received 3 consecutive exposures to the test materials. Each exposure was for 24 hours under semi-occlusive conditions.

Under the conditions of this study, occasional cases of slight skin irritation were observed with 10% v/v aqueous solutions of both samples. This irritation was in form of minimal erythema with slight glazing over the patch site. One subject displayed a response of definite erythema with marked glazing. This reaction was observed 24 hours after removal of the third application patch. For each sample, it appears that the incidence of irritation increases with each application. Both samples, under the conditions of this study, appear to be mildly irritating to the skin.