Registration Dossier

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:
disregarded due to major methodological deficiencies
Study period:
22 June 2011 - 08 July 2011
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study has many deviations and the information in the report is incomplete.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Principles of method if other than guideline:
The study has many deviations and the information in the report is incomplete.
- No data on range finding
- No information on toxicity included in the report, decrease in PCE/NCE ratio or clinical signs? No proof that the test subsatnce reached the target
- Results for the individual animals not reported
- No details on dosing of the animals, gavage? How were the solutions prepared? Which volumes were given?
- No details on animal housing and actual environmental conditions
- Bone marrow cells are usually obtained from the femurs or tibias immediately following sacrifice. In this study bone marrow from the sternum was used, no justification is provided.
- No details on slide preparation
- Besides statistical analysis no evaluation criteria are mentioned
- The laboratory has no GLP accreditation
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
Lot No.: 101155
odourless white solid

Test animals

Species:
mouse
Strain:
other: Kunming
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co., Ltd. (Certificate No. SCXK 2007-0001)
- Age at study initiation: no data
- Weight at study initiation: 20-30g
- Assigned to test groups randomly: yes, under following basis: no data
- Fasting period before study: NA
- Housing: no details provided
- Diet (e.g. ad libitum): Beijing Keaoxieli Feedstuff Limited Company (Certificate No. SLXK 2009-0012), not clear if it was provided ad libitum
- Water (e.g. ad libitum): Reverse osmosis filtered water, not clear if it was provided ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: 22 June 2011 - 08 July 2011

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: no data
- Amount of vehicle (if gavage or dermal): no data

Details on exposure:
PREPARATION OF DOSING SOLUTIONS: No data
Duration of treatment / exposure:
24 or 48 hours
Frequency of treatment:
single administration
Post exposure period:
24 or 48 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
215, 108, 54 mg/kg bw
Basis:
nominal conc.
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
cyclophosphamide
- Justification for choice of positive control(s): from the guideline
- Route of administration: IP
- Doses / concentrations: 40 mg/kg bw

Examinations

Tissues and cell types examined:
bone marrow erythrocytes
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: No data

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): a single dose was administered and animals were killed 24 and 48 hours after treatment.

DETAILS OF SLIDE PREPARATION: No details, Giemsa staining

METHOD OF ANALYSIS: No details

Evaluation criteria:
No data
Statistics:
χ2 test

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not examined
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Under the test conditions, the test substance does not cause chromosome aberrations in the tested species.
Executive summary:

Interpretation of results: negative

Under the test conditions, the test substance does not cause chromosome aberrations in the tested species.