Potassium mercaptoacetate

Endpoint summary

Description of key information

KTG is not irritating to skin or eyes. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: 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 2.6 ± 0.2 kg.
- Food and water: ad libitum
- Acclimation: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- temperature: 18 ± 3°C
- relative humidity: 30 to 70%
- light/dark cycle: 12 h/12 h
- ventilation: approximately 12 cycles/hour of filtered, non-recycled air.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Doses of 0.5 mL of the test item were placed on a dry gauze pad which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals. The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

Duration of treatment / exposure:

As possible irritant effects were anticipated, the test item was evaluated on a single animal in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
Since the test item was not severely irritating on this first animal, it was then applied for 4 hours to two other animals.

Observation period:

The skin was examined approximately 1, 24, 48 and 72 hour(s) after removal of the dressing.
Since there was persistent irritation reactions at 72 hours, the observation period was extended up to their complete reversibility (day 9).

Number of animals:

3

Irritation parameter:

erythema score

Remarks:

3-minute exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

3-minute exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Remarks:

4 -hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

4 -hour exposure

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Remarks:

4 -hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: Day 3

Irritation parameter:

edema score

Remarks:

4 -hour exposure

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Dryness of the skin (48h and 72h)

Irritation parameter:

erythema score

Remarks:

4 -hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: Day 8

Irritation parameter:

edema score

Remarks:

4 -hour exposure

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Conclusions:

Under our experimental conditions, the test item potassium thioglycolate 43% is slightly irritant when applied topically to rabbits. The criteria for classification as skin irritant are not met.

Executive summary:

After a 3-minute exposure (one animal), a very slight erythema (grade 1) was recorded on days 2 and 3. Dryness of the skin was recorded between day 3 and day 5.

After a 4-hour exposure (three animals), a very slight erythema (grade 1) was noted in 2/3 animals, from day 1 up to day 3 (one animal) or 8 (one animal). Dryness of the skin was recorded in 1/3 animals between day 3 and day 8.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.7 and 1.0 for erythema and 0.0, 0.0 and 0.0 for edema.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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)

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

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

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

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

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Conclusive, but not sufficient for classification.