Sodium 1,4-diisotridecyl sulphonatosuccinate

Eye irritation

Administrative data

Endpoint:

eye 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, 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:

according to guideline

Guideline:

other: FHSA, 16cfr1500.42 CPSC

Deviations:

no

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 1,4-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): Not provided
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- 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 / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Not provided

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL of the product as received was introduced into the conjunctival sac.

Duration of treatment / exposure:

Not provided

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):No

SCORING SYSTEM:
The scoring system used herein for eye irritation reactions is that of Draize, J.H., Woodward,
G., and Calvery, H.O.: J. Pharmacol. Exptl. Therap.82:377, 1944.
The maximum possible scores for eye irritation reactions (again excluding necrosis) are:
Cornea,80; Iris, 10; Conjunctivae, 20.

TOOL USED TO ASSESS SCORE: Not provided

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

14

Max. score:

80

Reversibility:

not fully reversible within: 72 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

10

Reversibility:

not fully reversible within: 72 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

6.3

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

26.7

Max. score:

80

Reversibility:

not fully reversible within: 72 h

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

10

Max. score:

80

Reversibility:

not fully reversible within: 72 h

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

20

Max. score:

80

Reversibility:

not fully reversible within: 72 h

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

3.3

Max. score:

80

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

21.7

Max. score:

80

Reversibility:

not fully reversible within: 72 h

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3.3

Max. score:

80

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

5

Max. score:

10

Reversibility:

not fully reversible within: 72 h

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 13

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 14

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 15

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

10

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

9.3

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

12

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 18

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

5.3

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.7

Max. score:

20

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 20

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

4

Max. score:

20

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 21

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

4.7

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 22

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

9.3

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 23

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

12

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 24

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

5.3

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 25

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2.7

Max. score:

20

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 26

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

4

Max. score:

20

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Results 27

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

4.7

Max. score:

20

Reversibility:

not fully reversible within: 72 h

Remarks on result:

other: Conjunctivae score : sum of conjunctivae redness, chemosis and discharge

Irritant / corrosive response data:

This product is irritating to the eye of the rabbit. Therefore, precautions should be observed to avoid its introduction into or near the eyes.

Any other information on results incl. tables

Table 1.Rabbit eye irritation results

Time, Hours	Structure	Rabbit Number, Value						Mean Value
		1	2	3	4	5	6
24	CORNEA	20	10	20	5	30	5	15
	IRIS	0	5	0	0	0	0	1
	CONJUNCTIVAE	10	12	6	8	8	8	9
48	CORNEA	20	10	20	5	30	5	15
	IRIS	0	5	0	0	0	0	1
	CONJUNCTIVAE	8	14	6	0	4	4	6
72	CORNEA	40	10	20	0	5	0	12
	IRIS	0	5	0	0	0	0	1
	CONJUNCTIVAE	10	10	4	0	0	2	4

 At the readings made at 24, 48 and 72 hours, there was:

- discernible opacity or ulceration of the cornea other than a slight dulling of the normal luster.

- no inflammation of the iris other than slight deepening of the folds, or slight circumcorneal injection.

- adiffuse, deep-crimson red appearance of the conjunctivae, with individual vessels not easily discernible.

- an obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids.

- no destruction or irreversible change of any tissue in 24 hours, or less.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Primary Eye irritation: Moderate Eye Irritation
Did not lessen significantly within 72 hours.

Executive summary:

0.1 g Butanedioic acid, sulfo-, 1,4 -ditridecyl ester, sodium salt (70% active) was introduced into the conjunctival sac of 6 rabbits. Scoring according to Draize et al. (1944) demonstrated a mean cornea score of 14/80, a mean iris score of 1/10 and a mean conjuctiva score of 6.3/20. At the readings made at 24, 48 and 72 hours, there was discernible opacity or ulceration of the cornea other than a slight dulling of the normal luster,adiffuse, deep-crimson red appearance of the conjunctivae, with individual vessels not easily discernible, and an obvious swelling of the conjunctivae, excluding cornea and iris, with partial eversion of the lids. It was concluded that the test item containing 70% active ingredient produces  irritation of rabbit eyes. Therefore, precaution should be observed to avoid its introduction into or near the eyes.