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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

November 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US Consumer Product Safety Commission, Code of Federal Regulations, Title 16, Section 1500.42

GLP compliance:

no

Remarks:

study performed before implementation of GLP

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

247-873-6

EC Name:

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

Cas Number:

26650-05-5

Molecular formula:

C17H29NO8S.2Na

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): REWOClD SBU 185 (10 % aqueous solution)
- Substance type: Sulfosuccinate (tensio-active)
- Physical state: Yellowish aqueous solution
- Analytical purity: Not provided
- Impurities (identity and concentrations): Water
- Lot/batch No.: 3637
- Expiration date of the lot/batch: Not provided
- Storage condition of test material: at 20 ° C and daylight

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: H. Schriever, Bremervörde, Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individual in wire mesh gages
- Diet: ad libitum, standard laboratory rabbit diet Ssniff K4
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod: 12 hours day night period, daylight from 6 am to 6 pm

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Each animal served as its one control. The test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: The test article REWOCID SBU 185 was applied in the original state (10% aqueous solution) as delivered by the sponsor

Duration of treatment / exposure:

Eyes were not rinsed after treatment.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done

SCORING SYSTEM: as stipulated by Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp, biomicroscope and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1,#2,#3,#4,#5,#6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

iris score

Basis:

animal: #1,#2,#3,#4,#5,#6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 9

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 10

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 12

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 13

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 14

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal: #1,#2,#4,#6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal: #3,#5

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 17

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 18

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 19

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 20

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 21

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 22

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 23

Irritation parameter:

chemosis score

Basis:

animal: #1,#2,#3,#4,#5,#6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 24

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 25

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 26

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 27

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 28

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 29

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

CLINICAL EYE OBSERVATION
- REWOCID SBU 185 (10 % aqueous solution) caused up to 24 hours post dosage a very slight reddening of the conjunctiva (erythema score 1) in 2/6 animals and slight increased mucous secretion (discharge score 1) in 1/6 animals.

REVERSIBILITY
- All symptoms were fully reversible on day 2 post dosing.

Any other information on results incl. tables

Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea Max. score: 4	Iris Max.score:2	Conjunctivae Max. score: 3	Chemosis Max.score : 4	Discharge Max.score: 3
24 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/1/0/1/0	0/0/0/0/0/0	0/0/0/0/1/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Day 7	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Average 24, 48, 72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0.33/0/0.33/0	0/0/0/0/0/0	0/0/0/0/0.33/0
Average 24, 48, 72 h (mean)	0	0	0.11	0	0.06
Reversibility*)	--	--	c	--	c
Time for reversion	--	--	2 days	--	2 days

 

*) Reversibility: c. = completely reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

test substance 10 % Criteria used for interpretation of results: OECD GHS

Conclusions:

Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility.
According to OECD GHS (2nd rev. edition, UN, 2007) REWOCID SBU (10% aqueous solution) is classified as non eye irritant.

Executive summary:

In a primary eye irritation study according to the US Consumer Product Safety Commission, Code of Federal Regulations, Title 16, Section 1500.42, 0.1mL of REWOCID SBU 185 (10 % aqueous solution) was instilled into the conjunctival sac of six White New Zealand rabbits. The eyes were not rinsed after substance application. Animals then were observed for 7 days. Irritation was scored by the method of Draize. REWOCID SBU 185 (10 % aqueous solution) caused up to 24 hours post dosage a very slight reddening of the conjunctiva (erythema score 1) in 2/6 animals and slight increased mucous secretion (discharge score 1) in 1/6 animals. All symptoms were fully reversible 2 days post dosage.