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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
From 25-05-1994 to 11-06-1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study performed according to OECD Guideline 404 without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): zirconium basic sulphate
- Substance type: white powder
- Physical state: solid
- Lot/batch No.: 4151805
- Analytical purity: 35.93% ZrO2 (loss on ignition) and 0.37% SiO2/ZrO2
- Purity test date: 2 May 1994
- Storage condition of test material: room temperature
- Other: date received: 09-05-1994 and provided by Thann et Mulhouse
- Other: The pH of the product at a concentration of 10% in water is 2.2.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2,6 ± 0,1 kg
- Housing: Individual housing in polystyrene cages with food and water delivery system
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum of 5 days before the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, i.e. 500 mg moistened with water

Duration of treatment / exposure:
First rabbit: 3 minutes (left side), 1 hour and 4 hours (right side)
Based on the results of first rabbit (product not very irritating) 2 other animals were tested: 4 hours exposure.
Observation period:
1, 24, 48 and 72 hours after removal of the test substance
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: left and right flanks
- % coverage: no data
- Type of wrap if used: The product was applied to a dry hydrophilic gauze and moistened with water. The gauze was applied to the animals left (animal 1) and right side (animals 1, 2 and 3). The gauze was kept in contact with the skin by a semi-occlusive hypoallergical plaster and a fixation aid.

REMOVAL OF TEST SUBSTANCE
- The substance was removed with a dry gauze.

SCORING SYSTEM: Draize scoring system of erythema and edema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
Only slight erythema was observed in 1 animal and was fully reversible within 48 hours.
Other effects:
No other effects observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, zirconium basic sulfate was oberved to be not irritating to rabbit skin.