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Diss Factsheets

Toxicological information

Toxicity to reproduction: other studies

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Administrative data

toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP was not implemented as were official testing guidelines at the time of study conduct. Study meets generally accepted scientific principles.
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
study report
Report date:

Materials and methods

Principles of method if other than guideline:
Male and female Wistat rats were fed with 0, 0.03, 0.1, 0.3, and 1 % TMP in diet and were observed for general appearance and behaviour. Growth, food intake hematology clinical chemistry data and data from, urinalysis were noted. At week 14 all rats were sacrificed and examined grossly and different organs were weighed ; Histopathological examinatiom was carried out.
GLP compliance:
Type of method:
in vivo

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
No data on purity but infra red spectrum is shown.

Test animals

Details on test animals or test system and environmental conditions:
50 male and 50 female weanling rats from the CIVO-colony were divided according to body weights over 5 groups of 10 males and 10 females each, and fed on stock diet with trimethylolpropane added at levels of 0, 0.03, 0.1, 0.3 and 1.0%..
the animals were housed in screen bottom cages (5 to a cage) in a room of constant temperature at ca. 24°C.
Food and tap water were constantely available.

Administration / exposure

Route of administration:
oral: feed
other: test substance was mixed with diet
Details on exposure:
the test compound was thoroughly mixed into the diet by means of a mechanical blender.
the diets were freshly prepared once a fortnight and stored at room temperature
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 d
Frequency of treatment:
Duration of test:
90 d
Doses / concentrations
Doses / Concentrations:
0.03,0.1, 0.3, or 1 % (corresponding to 20, 67, 200. pr 667 mg/kg bw/day)

No. of animals per sex per dose:
Control animals:
yes, plain diet
Details on study design:
post exposure period: no
yes, but method not mentioned

Results and discussion

Observed effects

reproductive organs:
female rat:
at 1% TMP in diet the average relative weight of ovars were significantly increases , but there was no pathological or histopathological correlate
male rats:
no findings were reported

Any other information on results incl. tables

For further details : see section 7.51 Repeated dose toxicity: oral

Applicant's summary and conclusion

Executive summary:

After feeding of trimethylolpropane to young male and female Wistar rats at 0, 0.03, 0.1, 0.3, 1.0 % in diet (corresponding to 20, 67, 200 or 667 mg/kg bw/d) for three months no adverse effects on reproductive organs of male Wistar rats were found; the significantly increased average relative weight of ovars in female rats occurred at clear toxic dose and was without pathological or histopathological correlate. Thus, this finding cannot be evaluated as specific effect due to reproductive toxicity.