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EC number: 258-054-8 | CAS number: 52628-25-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Macroscopic skin reactions, skin histological changes and epidermal keratin binding of the test material were observed after 5 d application of test material to skin using open patch test.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Zinc chloride
- EC Number:
- 231-592-0
- EC Name:
- Zinc chloride
- Cas Number:
- 7646-85-7
- IUPAC Name:
- zinc dichloride
- Details on test material:
- - Name of test material (as cited in study report): Zinc chloride
- Analytical purity: 98 % (minimum)
- Storage condition of test material: Test solution in deionized water was prepared 24 h before use and stored at 4 °C.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: TO (outbred) strain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Male
- Source: Charing Cross and Westminster Medical School, London, UK
- Age at study initiation: 8-10 wk
- Diet: Complete rodent diet (CRM, Biosure, Cambridge, UK), zinc content 65 mg/kg, w/w, ad libitum
- Water: Deionized water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55
- Photoperiod (h dark/h light): 12/12
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST SOLUTION
- Amount(s) applied (volume): 0.5 mL
- Concentration (if solution): 1 % w/v zinc chloride solution in deionized water
- pH: 5.6 - Duration of treatment / exposure:
- 5 d
- Observation period:
- Observed during and after 5 d exposure period
- Number of animals:
- Six animals both in test and control group
- Details on study design:
- Sites of 5 x 5 cm were treated with the test solution or vehicle for 5 consecutive days. Animals were gently anaesthetized with ether until the test sites had dried. Skin sites were observed during and after 5 d exposure period.
24 h after the fifth daily treatment, animals were killed and representative samples of each test and control skin sites were preserved in 10 % phosphate buffered formalin for histology. Thin sections cut along the anterior-posterior axis were stained with haematoxylin and eosin, or with morin dye, which fluoresces blue-green in the presence of zinc ions and ultraviolet light (to demonstrate zinc binding to epidermal keratin histologically).
SCORING SYSTEM: Not reported
Results and discussion
In vivo
Results
- Irritation parameter:
- other: not reported
- Irritant / corrosive response data:
- Severe irritation was observed in all animals of the test group after 5 d exposure. No reactions were observed in control group.
- Other effects:
- Histological changes: Profound epidermal hyperplasia with parakeratosis and ulceration was observed.
Morin fluorescence for zinc on skin: Very prominent blue-green fluorescence was observed indicating high binding of zinc to epidermal keratin.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, 1 % w/v zinc chloride was found to be severely irritating to mouse skin.
- Executive summary:
A study was conducted to evaluate the skin irritation potential of zinc chloride in TO (outbred) strain mice.
0.5 mL of 1 % w/v zinc chloride solution or vehicle was applied to clipped sites (5 cm2) of groups of six animals for 5 consecutive days. Skin sites were observed during and after 5 d exposure period. 24 h after the fifth daily treatment, animals were killed and representative samples of each test and control skin sites were analysed histologically and stained with morin dye to study epidermal keratin binding of zinc.
Severe irritation was observed in all animals of the test group after 5 d exposure. Profound epidermal hyperplasia with parakeratosis and ulceration were observed upon histological examination. No reactions were observed in control group. Very prominent morin fluorescence was observed in skin sections indicating high binding of zinc to epidermal keratin.
Under the test conditions, 1 % w/v zinc chloride was found to be severely irritating to mouse skin.
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