Sodium 1,4-dicyclohexyl sulphonatosuccinate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was not performed under GLP, however the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive patch, 24h exposure period, test with 6 animals

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,4-dicyclohexyl sulphonatosuccinate

EC Number:

245-629-3

EC Name:

Sodium 1,4-dicyclohexyl sulphonatosuccinate

Cas Number:

23386-52-9

Molecular formula:

C16H26O7S.Na

IUPAC Name:

sodium 1,4-bis(cyclohexyloxy)-1,4-dioxobutane-2-sulfonate

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Surfactant E-196 (80% active)
- Physical state: Not provided, however it is assumed to be a viscous liquid
- Analytical purity: 80%
- 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:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the product, prepared as an aqueous paste

VEHICLE

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

Not provided

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: primary irritation score

Basis:

mean

Time point:

other: 24 and 72 h

Score:

2.3

Max. score:

8

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 7

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 8

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Results 11

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

48 h

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

48 h

Remarks on result:

not measured/tested

Results 13

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

48 h

Remarks on result:

not measured/tested

Results 14

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 15

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Results 16

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Results 17

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 18

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #5

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not specified

Results 19

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #6

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 20

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 21

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 22

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 23

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 24

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 25

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 26

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Results 27

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Results 28

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Results 29

Irritation parameter:

edema score

Basis:

animal #4

Time point:

48 h

Remarks on result:

not measured/tested

Results 30

Irritation parameter:

edema score

Basis:

animal #5

Time point:

48 h

Remarks on result:

not measured/tested

Results 31

Irritation parameter:

edema score

Basis:

animal #6

Time point:

48 h

Remarks on result:

not measured/tested

Results 32

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 33

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 34

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 35

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 36

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 37

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Any other information on results incl. tables

Table1. Rabbit skin irritation

Conditions : 0.5 g of the product , prepared as an aqueous paste, was held under an impervious patch in continuous 24-hour contact with the shaved skin 

Time, Hours	Reaction	Rabbit Number, Value						Mean Value
		1	2	3	4	5	6
	ERYTHEMA
24	intact	2	1	2	2	2	2	1.8
72	intact	2	1	1	0	1	2	1.2
24	abraded	2	1	2	2	2	2	1.8
72	abraded	2	2	2	2	2	2	2.0
	EDEMA
24	intact	0	0	0	0	4	0	0.7
72	intact	0	0	0	0	0	0	0.0
24	abraded	0	0	0	4	4	0	1.3
72	abraded	0	0	0	3	0	0	0.5

  No structure of the tissue at the site of contact was destroyed or changed irreversibly in 24 hours or less.

 

Applicant's summary and conclusion

Interpretation of results:

Category II

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The report states: "Although this product produces some irritation of rabbit skin, it is not expected to produce significant skin irritation under conditions of ordinary industrial handling." However, based on the primary irritation score of 2.3 and erythema still present at 72 hours, the product is considered irritating.

Executive summary:

Six rabbits underwent a covered application to the clipped intact and abraded skin of 0.5 g Butanedioic acid, sulfo-, 1,4 -dicyclohexyl ester, sodium salt as an aqueous paste containing 80% active ingredient. Scoring according to Draize et al. (1944) demonstrated a primary irritation score of 2.3. It was concluded that the test item produces some irritation of rabbit skin. Although the design of the study was different from current OECD methods, irritation Category 2 according to CLP is concluded.