Registration Dossier
Registration Dossier
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EC number: 203-826-1 | CAS number: 111-02-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Remarks:
- Type of genotoxicity: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Literature study well described and of enough reliability to assess the endpoint
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity assessment of vaccine adjuvant squalene
- Author:
- D. Yüzbasıog˘lu et al.
- Year:
- 2 013
- Bibliographic source:
- Food and Chemical Toxicology 56 (2013)240–246
Materials and methods
- Principles of method if other than guideline:
- Assay, approximately 100 ul whole blood was collected from rat’s tail vein into lithium–heparintubes. Due to the intensity of cells, blood samples were diluted and suspended with phosphate buffer (pH:7.4)in 1:1 ratio and then centrifuged (Smith et al., 2008 ). Lymphocytes were isolated by Biocoll separating solution. After the isolation step, lymphocytes were resuspended in PBS (phosphate buffered saline).Afterwards, the protocol for in vitro comet assay described above was applied
- GLP compliance:
- not specified
- Type of assay:
- mammalian comet assay
Test material
- Reference substance name:
- 2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene
- EC Number:
- 203-826-1
- EC Name:
- 2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene
- Cas Number:
- 111-02-4
- Molecular formula:
- C30H50
- IUPAC Name:
- 2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene
- Details on test material:
- The test substance squalene (minimum98% purity) was purchased from Sigma and dissolved in physiological saline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Wistar rats (10–12weeks old) were procured from RefikSaydam National Public Health Agency, Experimental Animal Unit (Ankara, Turkey).Rats were kept in separate cages in an experimental room under controlled conditions of temperature (22±2 C) and humidity (50– 60%) with feed and water being available ad libitum. Lighting was controlled to provide 12 h artificial light followed by 12 h darkness.
Administration / exposure
- Route of administration:
- subcutaneous
- Duration of treatment / exposure:
- Group 1 was the treatment group studied 1day after the squalene injection.
Group 2 was studied 14 days after squalene injection - Frequency of treatment:
- Single
- Post exposure period:
- 1 and 14 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.07 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.14 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.28 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0.56 mg/Kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
1.12 mg/Kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 animals per dose
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- yes, with mitomycin-C 2 mg/Kg
Examinations
- Evaluation criteria:
- Quantification of DNA breakage was realized using Comet Image
Analysis System (‘‘Comet Assay IV’’, Perceptive Instruments Ltd., UK).At least 300
comets for each experimental group were recorded as tail length and tail intensity. - Statistics:
- For data evaluation, the z-test was used for the percentage of abnormal cells, CA/cell, MI, RI, NDI, MN assays. The t-test was applied for SCEs and comet assay results to determine the statistical difference between treated and untreated samples. Dose–response relationships were determined from the correlation and regression coefficients for the percentage of abnormal cells, CA/cell, SCE, mean MN and DNA.
Results and discussion
Test results
- Sex:
- not specified
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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