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Diss Factsheets

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined.

Data source

Reference Type:
Toxicological Studies on Tri-(2-Ethylhexyl)-Phosphate
MacFarland H.N.; Punte C.L.
Bibliographic source:
Archives of Environmental Health Vol. 13, pp.13-20

Materials and methods

Principles of method if other than guideline:
other: repeated dose toxicity inhalation study in guinea pigs
GLP compliance:
not specified
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-ethylhexyl) phosphate
EC Number:
EC Name:
Tris(2-ethylhexyl) phosphate
Cas Number:
Molecular formula:
tris(2-ethylhexyl) phosphate
Details on test material:
Mol wt: 434.6;
Sp g: 0.925 at 20 C;
n25D: 1.4473;
Surface tension: 31 dynes/sq cm;
Viscosity: 10.2 cp;
Vap press: 2 mm Hg at 200 C

Test animals

guinea pig

Administration / exposure

Route of administration:
Type of inhalation exposure:
whole body
other: no data
Remarks on MMAD:
MMAD / GSD: 3.8µ, with a geometric standard deviation of 1.7
Analytical verification of doses or concentrations:
Duration of treatment / exposure:
3 months
Frequency of treatment:
6h/d, 5d/w
Doses / concentrations
Doses / Concentrations:
1.6 and 9.6 mg/m³
analytical conc.
No. of animals per sex per dose:
Control animals:
Details on study design:
Post-exposure period: no

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
mortality observed, treatment-related
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
Effect level:
ca. 9.6 mg/m³ air

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

at high level significantly increased terminal body weight,
no significant alteration in red blood cell and plasma
cholinesterase activity, no abnormalties at necropsy,
microscopic examination revealed inconsistent and
reversible changes of renal parenchyma of the high level
group, sections of the spinal cord and sciatic nerve stained
to demonstrate the myelin sheaths showed no pathologic

Applicant's summary and conclusion

Executive summary:

In an old and limited documented 3 month repeated inhalation study in guinea pigs performed in the same laboratory two different concentrations of test substance aerosol were used in three chambers ( 1.6 and 9.6 mg/m³); the third served as control. The animals were exposed for six hours a day, five days per week, to a total of 60 exposures. Two deaths were recorded, one in the control and one in the low level test substance group; both deaths occurred during the ninth week of exposure. The only gross sign observed was piloerection, seen in both control and treated groups throughout the 12 -week period. Body weights decreased in all three groups during the first week of exposure but steadily increased in the succeeding weeks. The mean kidney weight to body weight ratio for both test substance groups was significantly lower than that of the control group. No significant differences were found in the red blood cell and plasma cholinesterase activities between the control group and either of the treated groups. Gross pathological examination of the two guinea pigs which died during the ninth week of exposure showed extensive consolidation of lung tissue. When the surviving animals were sacrificed at the end of the 12 week´s exposure, midly congested lungs were noted in a quarter of the guinea pigs in the control group, but no abnormalities were found in the test substance treated animals. Microscopic examination of the tissue revealed only inconsistent and apparently reversible changes in the renal parenchyma of the high level test substance groups. Histopathological alterations in the lung and liver were confined to those due to coincidental disease. Sections of the spinal cord and sciatic nerve stained to demonstrate the myelin sheaths showed no pathologic alteration.