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Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

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Administrative data

short-term repeated dose toxicity: dermal
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 dermal study in rabbits
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

New Zealand White
not specified

Administration / exposure

Type of coverage:
not specified
not specified
Details on exposure:
Route of Administration: dermal
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 to 4 weeks
Frequency of treatment:
5 d/w
Doses / concentrations
Doses / Concentrations:
0.1 ml/animal

No. of animals per sex per dose:
4 animals (2 weeks)
2 animals (4 weeks)
Control animals:
not specified
Details on study design:
Post-exposure period: 3 - 17 d


Observations and examinations performed and frequency:
see: any other information on materials and methods.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Dermal irritation:
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:
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:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
effects observed, treatment-related

Effect levels

Basis for effect level:
other: see 'Remark'
Remarks on result:
not measured/tested
Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

animals appeared normal and gained weight, no alterations
were observed at necropsy. Skin: moderate erythema
following the first application, following subsequent
applications, the erythema did not increase in intensity,
but a gradual increase in the size of the affected zone was
observed. After the fifths application desquamination,
hemorrhagic areas, thickening of the skin. Microscopic
examination: hyperkeratosis, parakeratosis, good recovery.

Applicant's summary and conclusion

Executive summary:

In an old and limited documented repeated dermal application study in rabbits the test substance was applied to the closely clipped, intact skin of the upper back of each of six male rabbits, at a daily dose of 0.1 ml. Applications were made on a five-day per week basis; four of the animals received a total of ten applications and the remaining two received 20 applications. The animals were observed for toxic effects and signs of dermal irritation daily. Initial, weekly, and terminal body weights were recorded. Two rabbits were sacrificed three days following the tenth application; two were sacrificed 17 days after the tenth application, and the remaining two on the third day after the 20th application. The animals appeared normal and gained weight; no alterations were observed at necropsy. In the skin moderate erythema following the first application, following subsequent applications was observed. The erythema did not increase in intensity, but a gradual increase in the size of the affected zone was observed. After the fifths application desquamination, hemorrhagic areas, thickening of the skin was seen. Microscopic examination revealed hyperkeratosis and parakeratosis. A Good recovery was evident in animals in which applications were stopped 17 days prior to sacrifice.