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EC number: 942-590-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- other: in vitro MTT test
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From April 3,2012 to March 3,2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliance with international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: MTT test method
- Deviations:
- no
- Principles of method if other than guideline:
- The method allows to evaluate a toxic event and related cytotoxicity by a colorimetric assay. Solution of MTT in balanced saline is yellowish in color. Mitochondrial dehydrogenase of viable cells cleaves the tetrazolium ring yielding blue/purple MTT crystals which are insoluble in aqueous solutions. Crystals formed by viable cells are retained in the polycarbonate filter used as substrate for the 3D construct. Intense purple colour of the cultures indicates the viability of the cell at the basal layer, whereas colour remains white when necrosis occurs. Negative controls are of a dark blue colour and positive controls are white-yellow.
MTT crystals are extracted by isopropanol and optical density is measured at 570 nm. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified
- IUPAC Name:
- Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): SSP-SAMPLE 1
- Water content: 15%
Constituent 1
Test animals / tissue source
- Species:
- other: HCE conrneal epithelium model
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Source:SKINETHIC LABORATORIES
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution):The test item was tested at the dose defined for liquid (30 µL). - Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- not required
- Number of animals or in vitro replicates:
- no aminals required
- Details on study design:
- The test was performed on triplicate tissues for MTT and in simplicate for histological analysis.
The positive control was Ethanol (99,96%) and as negative control saline solution (NaCl 0,9%) was used. 30 µL of controls (liquids) were directly and uniformly applied topically.
SCORING SYSTEM:cell viability
OTHER: the test was performed in triplicate
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Cell viability
- Basis:
- mean
- Time point:
- other: 1h + 16h
- Score:
- ca. 0.472
- Max. score:
- 100
- Reversibility:
- not specified
- Remarks on result:
- other: SD ± 0.039
- Irritant / corrosive response data:
- The prediction model for eye irritation ciassification is based on cell viability (MTT-modified protocol) after 1h+16h exposure (SOP M 04).
A cut-off of 50% is accepted for discriminating between potential irritant (<50 %) and not classified (>50 %). Positive control (Ethanol) satisfies acceptance criteria if it is classified as irritant (<50 %).
Mean tissue viability is <50 % Irritant (I) R36
Mean tissue viability is >50 % Not Classified (NC)
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A cell viability < 50% corresponding to the cut-off value for eye irritant classification has been quantified for positive control (0,6246%) and test item (0,4719%).
- Executive summary:
The present study has been conducted in order to assess in vitro, on a Human Corneal Epithelium model (HCE), the eye irritation potential of Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified.
Eye irritation potential of the test item was assessed at 1h followed by product washing and a post incubation period of 16h by using the MTT test method to quantify the residual cell viability. A complementary histo-morphological analysis was associated.
According to the adopted prediction model based on MTT results the chemicals have been classified as reported in the following table.
Classification based on cell viability-MTT results.
CHEMICAL 1h+16h CN NC ETOH IR S-0512 IR (NC=Not Classified; IR=Irritant for the eye, R 36 )
The scoring of the complementary histo-morphological analysis was in agreement with the cell viability results.
A cell viability < 50% corresponding to the cut-off value for eye irritant classification has been quantified for positive control (0,6246%) and test item (0,4719%).
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