Potassium mercaptoacetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07-Mar-2003 - 06-Aug-2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)

Test material

Test material information

Constituent 1

Reference substance name:

Potassium mercaptoacetate

EC Number:

252-038-4

EC Name:

Potassium mercaptoacetate

Cas Number:

34452-51-2

Molecular formula:

C2H4O2S.K

IUPAC Name:

potassium sulfanylacetate

Constituent 2

Reference substance name:

Potassiummercaptoacetate

IUPAC Name:

Potassiummercaptoacetate

Constituent 3

Reference substance name:

KTG

IUPAC Name:

KTG

Test material form:

solid - liquid: suspension

Details on test material:

- Content: 42.8% KTG
- pH 7.2
- Lot/batch No.: 4678
- Storage condition of test material: at room temperature and under nitrogen gas.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Breeder: CEGAV, Saint Mars d'Egrenne, France.
- Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.8 ± 0.2 kg
- Food and Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30-70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A single dose of 100 ml of the undiluted test item was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball.

Duration of treatment / exposure:

continuous

Observation period (in vivo):

1, 24, 48, 72 h

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: Day 3

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: Day 2

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the test item KTG 43% is practically non-irritant when administered by ocular route to rabbits, but experience with other thioglycolate salts show the irritating potential in general.

Executive summary:

The objective of this study was to evaluate the potential of the test item KTG 43% to induce irritation following a single ocular administration in rabbits.

Very slight or slight conjunctival reactions, including a very slight chemosis (grade 1) and a very slight or slight redness of the conjunctiva (grade 1 or 2), were noted in all animals on day 1 and persisted in one of them on day 2.

The evaluation of the discharge was masked by a test item flow in 2/3 animals, on day 1 only. No other ocular reactions were observed during the study.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.3, 0.0 and 0.0 for chemosis, 0.3, 0.0 and 0.0 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.