Tris(2-ethylhexyl) phosphate

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No OECD guideline or GLP defined.

Data source

Reference

Reference Type:

publication

Title:

Toxicological Studies on Tri-(2-Ethylhexyl)-Phosphate

Author:

MacFarland H.N.; Punte C.L.

Year:

1966

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris(2-ethylhexyl) phosphate

EC Number:

201-116-6

EC Name:

Tris(2-ethylhexyl) phosphate

Cas Number:

78-42-2

Molecular formula:

C24H51O4P

IUPAC Name:

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

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

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

Remarks:

Doses / Concentrations:
0.1 ml/animal
Basis:

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

Examinations

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:

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

Remarks:

Effect level not specified (migrated information)

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

RS-Freetext:
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.