Sodium 1,2-diisobutoxycarbonylethanesulphonate

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:

other: The study was performed with a +-45% active ingredient formulation, and not under GLP compliance. However, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA, 16cfr1500.41 CPSC

Principles of method if other than guideline:

FHSA: Federal Hazardous Substances Act
CPSC: Consumer Product Safety Commission

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1,2-diisobutoxycarbonylethanesulphonate

EC Number:

204-839-5

EC Name:

Sodium 1,2-diisobutoxycarbonylethanesulphonate

Cas Number:

127-39-9

Molecular formula:

C12H22O7S.Na

IUPAC Name:

sodium 1,4-diisobutoxy-1,4-dioxobutane-2-sulfonate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): AEROSOL® IB, Sodium di-iso-butyl sulfosuccinate
- Physical state: Not provided
- Analytical purity: 44-46 %
- 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:

0.5g of the product, prepared as an aqueous paste

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

Both intact and abraded skin were tested.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

4

Reversibility:

fully reversible within: 72h

Remarks on result:

other: for intact areas

Results 2

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

other: not specified

Results 5

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #2

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 9

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

other: not specified

Results 10

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 11

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 12

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 13

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 14

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

other: not specified

Results 15

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 16

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 17

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 18

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 19

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

48 h

Remarks on result:

other: not specified

Results 20

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 21

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #4

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 22

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 23

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #5

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 24

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

48 h

Remarks on result:

other: not specified

Results 25

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 26

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #5

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 27

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 28

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #6

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 29

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

48 h

Remarks on result:

other: not specified

Results 30

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 31

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 32

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 33

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 34

Irritation parameter:

edema score

Basis:

animal #1

Time point:

48 h

Remarks on result:

other: not specified

Results 35

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 36

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 37

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 38

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #2

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 39

Irritation parameter:

edema score

Basis:

animal #2

Time point:

48 h

Remarks on result:

other: not specified

Results 40

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 41

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 42

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 43

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 44

Irritation parameter:

edema score

Basis:

animal #3

Time point:

48 h

Remarks on result:

other: not specified

Results 45

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 46

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 47

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 48

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #4

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 49

Irritation parameter:

edema score

Basis:

animal #4

Time point:

48 h

Remarks on result:

other: not specified

Results 50

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 51

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 52

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 53

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #5

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 54

Irritation parameter:

edema score

Basis:

animal #5

Time point:

48 h

Remarks on result:

other: not specified

Results 55

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 56

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 57

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 58

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #6

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 59

Irritation parameter:

edema score

Basis:

animal #6

Time point:

48 h

Remarks on result:

other: not specified

Results 60

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 61

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Any other information on results incl. tables

Table1. Observations

Time, Hours	Reaction	Rabbit number, Value						Mean Value
		1	2	3	4	5	6
	Erythema
24	Intact	1	2	0	1	1	1	1.0
72	Intact	0	0	0	0	0	0	0.0
24	Abraded	2	2	1	1	2	2	1.7
72	Abraded	0	1	0	1	1	0	0.5
	Edema
24	Intact	0	0	0	0	0	0	0.0
72	Intact	0	0	0	0	0	0	0.0
24	Abraded	0	0	0	0	0	0	0.0
72	Abraded	0	0	0	0	0	0	0.0

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

The scoring system used herein for skin irritation reactions is that of Draize, J.H.,Woodward, G., and Calvery, H.O.: J. Pharmacol. Exptl. Therap., B2; 377,1944. The maximum possible value for a skin reaction (excluding necrosis) is 4. The “primary irritation score” is the sum of the mean values divided by 4.

Primary irritation score 0.8

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Primary irritation score of the test item containing 44-46% active ingredient in a Rabbit Skin Irritation Test with 0.5g in occlusive contact for 24 hours with shaved Skin was 0.8.This test item was only slightly irritating to rabbit skin. Therefore, it is not expected to produce significant skin irritation under conditions of ordinary industrial handling.

Executive summary:

6 Male albino rabbits underwent a covered application to the clipped intact and abraded skin of 0.5 g test item containing 44 -46% active ingredient as an aqueous paste. Scoring according to Draize et al. (1944) demonstrated a primary irritation score of 0.8, based on erythema which was reversible within 72 hours. It was concluded that the test item has no irritating potential under conditions of ordinary industrial handling.