Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline, GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Triisotridecyl phosphite
- EC Number:
- 278-758-9
- EC Name:
- Triisotridecyl phosphite
- Cas Number:
- 77745-66-5
- Molecular formula:
- C39H81O3P
- IUPAC Name:
- triisotridecyl phosphite
- Test material form:
- other: liquid
- Details on test material:
- Triisotridecyl phosphite
Lankromark LE571
Batch: W024077 (3284/047)
Analytical purity: 98%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were 7 to 8 weeks old on day one of dosing. The females were nulliparous and not pregnant. Male weights: 32-37 g; Female weights: 23-34 g; at the start of the study.TEST ANIMALS- Source:- Age at study initiation: 7 to 8 weeks old on day one of dosing- Weight at study initiation: Males: 32-37 g; Female weights: 23-34 g- Assigned to test groups randomly: yes- Housing: Group (5 animals of same sex per cage)- Acclimation period: 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 - 23°C- Humidity (%): 65 - 67 %- Air changes (per hr): Minimum 15 air changes per hour.- Photoperiod (hrs dark / hrs light): 12 h artificial light (06:00 - 18:00 h) and 12 h darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- vegetable oil
- Details on exposure:
- 2000 mg/kg bw of TiTDP was given in vegetable oil via oral gavage for two consecutive days.
- Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:2000 mg/kg bwBasis:actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin-C, 1 mg/kg bw was used as a positive, concurrent, control
Examinations
- Tissues and cell types examined:
- Femoral bone marrow
- Details of tissue and slide preparation:
- SAMPLING TIMES: Vehicle control and treated groups (18 - 24 h after last treatment); Positive control (24 h after last treatment)
- Evaluation criteria:
- per Test Guideline
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY- Induction of micronuclei (for Micronucleus assay): No- Ratio of PCE/NCE (for Micronucleus assay): P/E ratio was 12.40% lower in treated male animals and 1.18% higher in treated female animals than in their respective vehicle control animals. These differences were not considered to be biologically significant.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negativeBased on the results of the study, it is concluded that TiTDP does not have micronucleus induction potential in male and female mice.
- Executive summary:
In a reliable OECD 474 Guideline GLP study, TiTDP did not cause micronucleus induction in male and female mice when administered at a limit dose of 2000 mg/kg bw by gavage for two consecutive days.
Note
An in vivo study was conducted due to concerns about the hydrolytic instability of the test substance in the in vitro test system. Also, this test is preferred still amongst some non-EU regulatory agencies and this particular study was done for non-REACH purposes as well.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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