Registration Dossier
Registration Dossier
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EC number: 237-324-9 | CAS number: 13746-89-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Zirconium di(acetate) oxide
- EC Number:
- 225-924-3
- EC Name:
- Zirconium di(acetate) oxide
- Cas Number:
- 5153-24-2
- IUPAC Name:
- 5153-24-2
- Details on test material:
- - Name of test material (as cited in study report): zirkon-acetate
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 1.9-2.8 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: pelleted standard Kliba 341, Batch 17/86 rabbit maintenance diet, ad libitum
- Water: community tap water from Itingen, ad libitum
- Acclimation period: 3 days under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- TEST SITE
After approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 x 10 cm). On test day 1, 0.5 ml of the test article was applied to the intact skin of the shaved area. It was covered with a 3 x 3 cm patch of surgical gauze. The gauze was covered with aluminium foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushing with luke warm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Maximum possible score: 4
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1 mm): 3
Severe edema (raised mode than 1 mm and extending beyond area of exposure): 4
Maximum possible score: 4
Maximum cumulative score: 8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Local signs (mean 1 hour to 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema. In the area of application no staining of the treated skin by pigment or coloring of the test article was observed. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
- Other effects:
- The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. Due to the results obtained, no macroscopic organ examination was indicated.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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