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EC number: 606-441-0 | CAS number: 201305-16-0
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted similar to the appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (2010)
- Deviations:
- yes
- Remarks:
- (study report with limited information)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzoic acid, C12-15-alkyl esters
- EC Number:
- 270-112-4
- EC Name:
- Benzoic acid, C12-15-alkyl esters
- Cas Number:
- 68411-27-8
- IUPAC Name:
- 68411-27-8
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: 117-854
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: normal, human-derived epidermal keratinocytes (NHEK)
Test system
- Type of coverage:
- other: Not applicable.
- Preparation of test site:
- other: NHEK were cultured to form a multilayered, highly differentiated model of the human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent negative control (treatment not further specified in study report) and concurrent positive control treated with 1% Triton X 100
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL - Duration of treatment / exposure:
- 1, 4.5 and 20 h
- Observation period:
- Not applicable.
- Number of animals:
- Not applicable.
- Details on study design:
- CELL EXPOSURE
- After the appropriate tissue preparation, 100 µL of the test, reference and negative control articles were added to the Millicells containing the EpiDerm samples. The 6 well plates containing the dosed EpiDerm samples were then incubated at 37°C, 5% carbon dioxide and >90% humidity.
MTT TEST
- After the appropriate exposure periods, each insert was individually removed from its plate and rinsed with phosphate buffered saline (PBS) to remove any residual test material. Each were then rinsed a second time. Excess liquid was shaken off and each EpiDerm sample was placed into 300 microliters of MTT solution. The EpiDerm samples were then returned to the incubator.
- After the 3 h MTT exposure, each insert was removed and gently rinsed with PBS to remove any residual MTT solution. Excess PBS was shaken from each of the inserts which were then blotted on the bottom on paper towels. The inserts were then each placed into 1 well of a 24 well extraction plate. Each insert was then immersed in 2 mL of extraction solution overnight.
ABSORBANCE/OPTICAL DENSITY MEASUREMENT
- After the exposure, the liquid within each insert was decanted back into the well from which it was taken. The remaining extractant solution was then agitated and a 200 µL aliquot of each extract was removed for evaluation. A Dynatech MR 4000 Automatic Microplate Reader was used to determine the absorbance of each extract at 570 nm. With the absorbance of the negative control defined as 100%, the percent absorbancies of the test and reference articles were determined.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of negative control. Time point: 1 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 85
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of test material. Time point: 1 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 78
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of positive control. Time point: 1 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of negative control. Time point: 4.5 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 80
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of test material. Time point: 4.5 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 37
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of positive control. Time point: 4.5 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of negative control. Time point: 20 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 78
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of test material. Time point: 20 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 5
- Remarks on result:
- other:
- Remarks:
- Basis: other: value of positive control. Time point: 20 h. Max. score: 100.0. Reversibility: other: reversibility: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- The test article elicited an ET50 greater than 24 hours. The positive control substance, 1% Triton X 100, elicited an ET50 of approximately 2.9 hours.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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