Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study, conducted for the National Toxicology Program
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
Evaluation of a Three-Exposure Mouse Bone Marrow Micronucleus Protocol: Results with 49 Chemicals
Shelby MD, Erexson GL, Hook GJ & Tice RR
Bibliographic source:
Environmental and Molecular Mutagenesis, 21, 160-179 (1993)

Materials and methods

Test guidelineopen allclose all
equivalent or similar to guideline
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
according to guideline
other: NTP protocol
GLP compliance:
: published literature study
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl terephthalate
EC Number:
EC Name:
Dimethyl terephthalate
Cas Number:
Molecular formula:
dimethyl terephthalate
Details on test material:
The test chemical was received from the NTP chemical repository (Radian Corporation, Austin).

Test animals

Details on test animals or test system and environmental conditions:
Male B6C3F1 mice obtained from the National Toxicology Program production facility at Taconic Farms of a common age between 9 and 14 weeks and weighing between 25 and 33 g were used (within a 2 g range of the mean)

Administration / exposure

Route of administration:
Each chemical was prepared in the appopriate solvent (PBS for water soluble chemicals, corn oil for water insoluble chemicals). All test chemicals were administered within 30 min of preparation.
Details on exposure:
The test substance was administered by intraperitoneal injection at a volume of 0.4 ml per mouse. Three consecutive daily injections were carried out per mouse.
Duration of treatment / exposure:
The test chemical was administered by IP injection on three consecutive days.
Frequency of treatment:
The test chemical was administered by IP injection on three consecutive days.
Post exposure period:
The animals were monitored twice daily and 24 hours after the third treatment (48 h in preliminary experiments).
Doses / concentrations
Doses / Concentrations:
0, 438, 875 and 1750 mg/kg bw
other: actual administered dose
No. of animals per sex per dose:
In the preliminary dose determination studies, 5 mice per group were used.
Groups of 5 to 6 male mice were used per dose in the micronucleus (MN) initial test.
Control animals:
yes, concurrent vehicle
Positive control(s):
DMBA in corn oil was used as the positive control


Tissues and cell types examined:
Bone marrow
Details of tissue and slide preparation:
24 h after the third treatment, surviving mice were euthanised by CO2 asphyxiation.
Bone marrow smears (two slides mouse) were prepared, fixed in absolute methanol and stained with acridine orange.
Evaluation criteria:
Bone marrow smears from each animal were evaluated at 1000x magnification using epi-illuminated fluorescence microscopy (450-490 nm excitation, 520 nm emission) for determination of the percentage of PCE among 200 erythrocytes.
The data were analysed using the Micronucleus Assay Data Management and Statistical software package. To determine whether a specific tretament resulted in a significant increase in MN-PCE, the number of MN-PCE were pooled within each dose group and analysed by a one tailed trend test.

Results and discussion

Test results
no effects
Vehicle controls validity:
Negative controls validity:
not examined
Positive controls validity:
Additional information on results:
The initial result was negative to 1750 mg/kg bw and was therefore the test was not repeated. There were no mortalities at any dose.

Any other information on results incl. tables

The result of this study contrasts with the positive findinings reported by Goncharova et al (1988), in which dimethyl terephthalate was reported to induce micronuclei in the bone marrow cells of male mice following single intraperitoneal injections of doses ranging from 0.2 to 1.0 mmol/kg (approximately 33 to 166 mg/kg bw). It is notable that DMSO was used as the solvent in that study, which may have contributed to the difference in results between these two studies.

Applicant's summary and conclusion

Interpretation of results (migrated information): negative
DMT did not induce micronuclei in the bone marrow of male mice following three intraperitoneal injections up to a dose of 1750 mg/kg bw.
Executive summary:

Dimethyl terephthalate was tested in the mouse bone marrow micronucleus assay, for the US National Toxicology Program. The test substance was administered in three daily exposures by intraperitoneal injection, at doses of 0, 438, 875 and 1750 mg/kg bw. Bone marrow samples were obtained 24 h following the final exposure. DMT did not induce micronuclei in the bone marrow of male mice following three intraperitoneal injections at up to and including a dose of 1750 mg/kg. Administration of DMT did not result in any mortality.