Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt.
Specific details on test material used for the study:
It cannot be entirely excluded that the test material used was the mono potassium salt rather than the di potassium salt. However, based on the very similar properties of these compounds, the toxicological data presented is considered valid and suitable to describe the toxicological property of the di potassium salt even if generated with the mono salt.

Test animals

Species:
rabbit
Strain:
other: White New Zealand HsdIf: NZW (SPF)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen, GER
- Age at study initiation: About 8 months
- Weight at study initiation: 3.46 - 3.98 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day).
- Water: Tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
moistened with aqua bidest
Controls:
other: Untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3 (1 male, 2 female)
Details on study design:
TEST SITE
- Area of exposure: Upper third of the back or flanks
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull(R) stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol(R)** and Lutrol(R)/water (1:1).
- Time after start of exposure: 4h

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Two out of three animals showed an erythema with a score of 1 at the 1h and 24 h time points. The finding disappeared after 48 hours. The third animal was free of findings. No edema was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Considering the non-observed cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.
Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 White New Zealand rabbits for 4 hours under semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed approximately 1, 24, 48 and 72 hours after removal of the patch. Slight erythema was observed in 2 animals on the day of application and 24 hours after removal of the patch. No edema was observed. The cutaneous reactions were reversible in these 2 animals within 48 hours after removal of the patch. The average score (24 to 72 hours) for irritation was calculated to be 0.2 for erythema and 0 .0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the skin under the test conditions chosen.