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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
prior to 1946
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data for interpretation of study results
Justification for type of information:
Read across is based on the category approach. Please refer to attached category document.

Data source

Reference
Reference Type:
publication
Title:
Comparison of the Chronic Toxicity of Triethylene Glycol that of Diethylene Glycol
Author:
Fitzhugh, O.G. and Nelson, A.A.
Year:
1946
Bibliographic source:
J Ind Hyg Toxicol. 1946 Mar; 28:40-3.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Two year bioassay comparing the toxicity of triethylene glycol to diethylene glycol (data not presented for diethylene glycol).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-(ethylenedioxy)diethanol
EC Number:
203-953-2
EC Name:
2,2'-(ethylenedioxy)diethanol
Cas Number:
112-27-6
Molecular formula:
C6H14O4
IUPAC Name:
2,2'-[ethane-1,2-diylbis(oxy)]diethanol
Test material form:
not specified
Details on test material:
triethylene glycol was used. No further information supplied in paper.

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male
Details on test animals or test system and environmental conditions:
Male rats from their own colony (Dept. of Pharmacology, Food and Drug Administration, Washington, D.C.) of Osborne-Mendel strain were used. They were selected at random with respect to litter mates. Three rats were chosen from each of 7 litters and assigned to different diets as required for balanced incomplete blocks of 3 with 7 treatments, where the blocks correspond to litters and the treatments to diets. The design was replicated as a whole 4 times, giving a total of 84 rats. Three groups of rats were placed on 1, 2 and 4 percent diethylene glycol and three other groups were placed on 1, 2 and 4 percent triethylene glycol. the seventh ration was the control diet without added glycol.

Ground commercial rat biscuits with 1 percent added cod liver oil were used as a basic diet. the rats were kept in individual cages in a room with the temperature and humidity controlled for the duration of the experiment, and they were griven free access to their respective diets and water.

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on exposure:
Groups of rats were fed 1, 2 or 4% triethylene glycol in the diet
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data.
Duration of treatment / exposure:
2 years
Frequency of treatment:
continuous in feed
Post exposure period:
No data
Doses / concentrations
Remarks:
Doses / Concentrations:
1, 2 or 4%
Basis:
nominal in diet
No. of animals per sex per dose:
12 males/dose level
Control animals:
yes, plain diet
Details on study design:
Three groups of rats were placed on 1, 2 and 4 percent diethylene glycol (data not presented here) and three other groups were placed on 1, 2 and 4 percent triethylene glycol. the seventh ration was the control diet without added glycol. The weights of individual animals and their food consumption were determined at weekly intervals.
Positive control:
No data.

Examinations

Observations and examinations performed and frequency:
The weights of individual animals and their food consumption were determined at weekly intervals.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
There was no effect on mortality of rats fed 1, 2 or 4% triethylene glycol in the diet for 2 years.

When the data for the weekly food consumption of each group during the first 26 weeks and the second 26 weeks of the experiment were analyzed, the differences between the control and experimental animals were not statistically significant.

Pathological Changes. All of the 84 rats used in these experiments (NOTE: Some rats were fed diethylene glycol which is not included here but can not be separated out in text) were examined for gross visceral changes, and 48 of the 84 were sectioned microscopically. Routine sections included lung, heart, liver, spleen, pancreas, stomach, small intestine, colon, kidney, adrenal, testis and bladder tumors. Bladder, prostate, seminal vesicle, leg bones, bone marrow, voluntary muscle, thyroid and lymph node were sectioned in some animals.

In rats fed triethylene glycol pathological changes were essentially absent. In the rats fed triethylene glycol and in the untreated controls there were no stones or tumors in the urinary tracts. Liver, lung, heart, spleen, pancreas, stomach, small intestine, colon, adrenal, testis, prostate, seminal vesicles, bone, bone marrow, voluntary muscle, lymph node and thyroid showed either no changes attributable to triethylene glycol, or else changes so slight or infrequent that they were of questionable significance.
Relevance of carcinogenic effects / potential:
Triethylene glycol produced no toxic effect, including cancer, at doses as high as 4% in the diet.

Effect levels

Dose descriptor:
NOEL
Effect level:
4 other: percent in the diet
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No effects were noted in male rats fed 4% triethylene glycol in the diet.
Remarks on result:
other: Effect type: toxicity

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Conclusions:
Triethylene glycol produced no toxic effect at doses as high as 4% in the diet.
Executive summary:

In a 1946 era study, groups of 12 male rats were fed 0, 1, 2 or 4 percent triethylene glycol in the diet for 2 years. In this study, triethylene glycol produced no toxic effect at doses as high as 4% in the diet.