Sodium 1,4-diisotridecyl sulphonatosuccinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1968

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted non-GLP, with limited data on study design, however the study was conducted according to state of the art methods at that time period. The study is considered adequate, reliable and relevant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

6 animals, 72h observation period

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,4-diisotridecyl sulphonatosuccinate

EC Number:

259-515-6

EC Name:

Sodium 1,4-diisotridecyl sulphonatosuccinate

Cas Number:

55184-72-0

Molecular formula:

C30H58O7S.Na

IUPAC Name:

sodium 1,4-bis[(2-methyldodecyl)oxy]-1,4-dioxobutane-2-sulfonate

Test material form:

other: slightly viscous liquid

Details on test material:

- Name of test material (as cited in study report): Aerosol TR-70 sodium Bis-tridecyl Sulfosuccinate
(70% aqueous solution)
- Physical state: Not provided, but it is assumed that the test material is a slightly viscous liquid
- Analytical purity : 70%
- 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: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

Not provided

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of the product as received

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: primary irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

8

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

intact skin

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

intact skin

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

intact skin

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 5

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

intact skin

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 6

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

intact skin

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 7

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

intact skin

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 8

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

intact skin

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no data on 48 h observation

Results 9

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

intact skin

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 10

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

intact skin

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 11

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

intact skin

Time point:

24/48/72 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 12

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

intact skin

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Results 13

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

intact skin

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: no data on 48 h observation

Any other information on results incl. tables

Table1. Rabbit skin irritation results

Time, Hours	Reaction	Rabbit Number, Value						Mean Value
		1	2	3	4	5	6
	ERYTHEMA
24	intact	2	2	2	2	1	2	1.8
72	intact	1	1	2	2	1	1	1.3
24	abraded	2	2	2	2	1	2	1.8
72	abraded	1	1	1	2	1	0	1.0
	EDEMA
24	intact	0	2	2	4	1	1	1.7
72	intact	0	0	0	1	0	1	0.3
24	abraded	0	0	0	4	2	1	1.2
72	abraded	0	0	0	1	0	0	0.2

Structure of the tissue at the site of contact was not destroyed or changed irreversibly in 24 hours or less.

Primary Irritation Score: 2.3 (Sum of the mean values divided by 4)

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The Primary Skin Irritation score of the test item Butanedioic acid, sulfo-, 1,4-ditridecyl ester, sodium salt ( 70% active ingredient) was 2.3.

Executive summary:

0.5 mL of Butanedioic acid, sulfo-, 1,4-ditridecyl ester, sodium salt (70% active ingredient) was held under an impervious patch in continuous 24-hour contact with the shaved skin of 6 rabbits. Erythema and edema were observed in all animals on abraded and intact skin at 24 hours, which had not reversed by 72 hours. The overall primary irritation score was 2.3. The structure of the tissue at the site of contact was not destroyed or changed irreversibly within 24 hours.