α,α,α',α'-tetramethyl-m-xylene-α,α'-diol

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:

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

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

Test material information

Constituent 1

Reference substance name:

α,α,α',α'-tetramethyl-m-xylene-α,α'-diol

EC Number:

217-886-1

EC Name:

α,α,α',α'-tetramethyl-m-xylene-α,α'-diol

Cas Number:

1999-85-5

Molecular formula:

C12H18O2

IUPAC Name:

2-[3-(2-hydroxypropan-2-yl)phenyl]propan-2-ol

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 or test system 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.