Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across study

Justification for type of information:

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Refer to section 13 for read-across justification.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

EC Number:

939-529-5

Molecular formula:

not applicable, substance is a UVCB substance containing several constituents

IUPAC Name:

Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 - 5 month
- Weight at study initiation: 2.4 - 3.6 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg/ eye
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: no irritation observed

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

iris score

Remarks:

overall

Basis:

mean

Remarks:

al animals

Time point:

24/48/72 h

Score:

0.78

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

conjunctivae score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 13

Irritation parameter:

chemosis score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

2.1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 14

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 15

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 16

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on the study results, the read-across source substance sodium methyl cocoyl taurate (SMCT) is irritating to rabbit eyes.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be irritating to rabbit eyes.

Executive summary:

The primary eye irritation potential of sodium methyl cocoyl taurate (SMCT) was evaluated according to OECD Guideline 405 in the New Zealand albino rabbit. Only animals without ocular abnormalities were used for the study. 100 mg of undiluted test material was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. From 1 hour up to 3 days after administration the conjunctivae of the animals showed swellings above normal up to swellings with lids about half closed and definitely injected blood vessels up to a diffuse beefy red colour. The iris was reddened in two animals up to day 2 and in the remaining animal until day 3 p.a. The cornea of two animals showed scattered areas of opacity up to easily discernible translucent areas. All signs of irritation were reversible within 7 days post exposure. Based on the results of this study, SMCT is considered to be irritating to rabbit eyes.

This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. Hence, SMLT is considered to be irritating to rabbit eyes.