Registration Dossier
Registration Dossier
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EC number: 237-401-7 | CAS number: 13772-29-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2014-03-04 to 2014-07-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008 of 30 May 2008, Part B (In Vitro Skin Corrosion: Human Skin Model Test) (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Zirconium bis(hydrogen phosphate)
- EC Number:
- 237-401-7
- EC Name:
- Zirconium bis(hydrogen phosphate)
- Cas Number:
- 13772-29-7
- Molecular formula:
- H3O4P.1/2Zr
- IUPAC Name:
- hydrogen phosphate;zirconium(4+)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- other: human epidermis model (EpiDermTM)
- Details on test animals or test system and environmental conditions:
- Test system
The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm2) are cultured on specially prepared cell culture inserts and commercially available as kits (EpiDermTM 200).
Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- water
- Controls:
- other: Control tissues were treated with 50 μL of de-ionized water (negative control) or with 50 μL of 8 N potassium hydroxide (positive control).
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 25 µL
- Concentration: 50 % (v/v) in water
VEHICLE
- Amount applied: 25 µL de-ionized water - Duration of treatment / exposure:
- 3 min and 1 hour
- Observation period:
- After removal of the test substance, the tissues were incubated with MTT solution for 3 hours. Afterwards formazan production was measured.
- Number of animals:
- Two tissues per exposure time and test group (test material, positive and negative substance) were used.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: viability [% of negative control]
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 100
- Irritation parameter:
- other: viability [% of negative control]
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 113
- Irritant / corrosive response data:
- Evaluation of results:
Corrosive potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with de-ionized water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50 %. In addition, those materials with a viability of ≥ 50 % after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15 %. Therefore, the test substance is not considered to be corrosive in this study.
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
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