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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

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

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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)

Test material

Constituent 1
Chemical structure
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:
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

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.

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.