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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:
8 May 2002 to 17 May 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
A GLP study performed to standardised guidelines with a sufficient level of detail to assess the quality of the submitted data. The study was conducted with a solution of potassium zirconium carbonate, rather than the pure solid, the results of the study are considered to be the worst case scenario since the solution has a higher pH (ca. 11 vs. 9.2). As such the results are considered to be reliable and suitable for addressing this endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Protocol Deviations:
- Dosing was performed twice for animals BWR9 and BWN5 during the exposure period to ensure a close contact between the test material and the skin
- Animals dosed were female instead of male
- To ensure the well being of the animals during the study the food was changed

These deviations were considered to have no effect on the outcome of the study.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Potassium Zirconium Carbonate
IUPAC Name:
Potassium Zirconium Carbonate
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, Horst
- Weight at study initiation: 2059-2191 g
- Housing: individually housed during study
- Diet: Lactamin K-5; Batch100 120 g/day
- Water: tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 55 ± 15%
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
On the day before application of the test material each rabbit was prepared by clipping the hair from the back and sides using a hair clipper. The exposure area was 2.5 cm x 2.5 cm and was marked using a water-resistant marker before dosing. On the day of dosing, a dose of 0.5 ml of test material was applied to a gauze patch. The test area was covered with the gauze patch and was held in place with a non-irritating tape. Animals were restrained in a restraining table during the exposure period to prevent the animals from reaching the exposed skin area.

0.5 ml of test material was applied again on the patch (animals BWR9 and BWN5) two hours after the first application.

POSITIVE CONTROL
The positive control used was the reference item 1% dodecylsulfat (SDS). 0.5 ml of 1% SDS was applied to the gauze patch under the same conditions as the test material. As with the test material, 0.5 ml 1% SDS was re-applied to the gauze patch 2 hours after the first application.
Duration of treatment / exposure:
4 hours
Observation period:
Tested animals were observed twice a day (morning and afternoon) for general well being. The animals were observed daily for clinical signs and all clinical signs were recorded. Animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Number of animals:
4 (3 were treated with test material and 1 recieved a dose of the positive control, dodecylsulfat- SDS)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was not performed

SCORING SYSTEM: Dermal irritation/corrosion was scored and recorded according to the grading of skin reaction according to OECD Guideline 404. The scoring system used in the study is presented in Table 1 in the field "Any other information on materials and methods incl. tables"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 2 and 3 days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 2 and 3 days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Animal BWR9 had a very slight erythema 60 minutes after patch removal. The positive skin reaction was reversible within 1 day. The observed positive skin reactions for the reference item (positive control) was as expected (Animal no BWC2).
Other effects:
No abnormal clinical signs were observed during the study.
Bodyweight change: two animals gained weight and one animal lost a small amount of weight.

Any other information on results incl. tables

Table 2: Erythema/eschar and oedema formation after 4 hours exposure

Raisacooat KZ 20 Erythema and Eschar (score 0-4) Oedema (score 0-4)  
Time period (h) Time period (h)
Rabbit no. 1 24 48 72 1 24 48 72 Sum
BWC2 0 0 0 0 0 0 0 0 0
BWN5 0 0 0 0 0 0 0 0 0
BWR9 1 0 0 0 0 0 0 0 1
Sum 1 0 0 0 0 0 0 0  
Mean 0.33 0 0 0 0 0 0 0
1% SDS Time period (h) Time period (h)  
Rabbit no. 1 24 48 72 1 24 48 72 Sum
BWC2 1 2 1 1 0 0 0 0 5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The skin irritation potential of the test material was determined in accordance with the standardised guidelines OECD 404. The rabbits were each exposed to a dose of 0.5 ml test material for 4 hours and observed for the following 3 days for any sign of skin irritation. A single rabbit was dosed in the same way to a 0.5 ml dose of 1% SDS which acted as a positive control for the test. As expected, there was a positive skin reaction for the reference item. In animals dosed with the test material only animal BWR9 showed very slight erythema 60 minutes after patch removal. The positive skin reaction was reversible within one day. There were no other signs of skin irritation.

Under the conditions of the study, the test material is considered to be practically non-irritating to the skin based on an internal system for description of irritation responses. The test material does not require classification for skin irritation in line with Regulation No 1272/2008.