2-ethylhexyl diphenyl phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March, 1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was not conducted according to an existing OECD guideline, and no data on GLP, but acceptable basic information.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In this Range Finding Acute Oral Toxicity study the acute oral toxic effects of Santicizer 141 was tested in Sprague Dawley strain albino male and female rats. The undiluted compound was fed by stomach tube at 6 doses (2000, 5010, 7940, 10000, 12600, and 15800 mg/kg). Number of animals were: 1 female at 2000, 5010, and 7940 mg/kg; 5 animals/sex at 10000, 12600, and 15800 mg/kg. Daily observations were made for 10 days for toxic symptoms and the viscera of the test animals were examined macroscopically.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl diphenyl phosphate

EC Number:

214-987-2

EC Name:

2-ethylhexyl diphenyl phosphate

Cas Number:

1241-94-7

Molecular formula:

C20H27O4P

IUPAC Name:

2-ethylhexyl diphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): Santicizer 141
- Lot/batch No.: QK 735

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS: No data

ENVIRONMENTAL CONDITIONS: No data

IN-LIFE DATES: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

2000, 5010, 7940, 10000, 12600, and 15800 mg/kg

No. of animals per sex per dose:

2000, 5010, and 7940 mg/kg: 1 female; 10000, 12600, and 15800 mg/kg: 5 animals/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: observation of toxic symptoms: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No data

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 800 mg/kg bw

Mortality:

1 female died at dose 12600 and 15800 mg/kg. Survival time was 3 to 5 days.

Clinical signs:

other: Toxic symptoms included diarrhea for 1 day, reduced activity and appetite, and tremors and increasing weakness to near collapse lasting 5 to 7 days in animals of the last 3 groups.

Gross pathology:

At autopsy there were hemorrhagic areas of the liver, lungs, and kidneys, and intestinal inflammation. Surviving animals were sacrificed 10 days after dosing. Hemorrhagic areas of the lungs were observed in a few instances; otherwise the viscera appeared normal by macroscopic examination.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 was found to be > 15800 mg/kg. Based on these results and according to the EU classification criteria outlined in 67/548/EEC and 1272/2008 the substance does not have to be classified.

Executive summary:

In this Range Finding Acute Oral Toxicity study the acute oral toxic effects of Santicizer 141 was tested in Sprague Dawley strain albino male and female rats. The undiluted compound was fed by stomach tube at 6 doses (2000, 5010, 7940, 10000, 12600, and 15800 mg/kg). Number of animals were: 1 female at 2000, 5010, and 7940 mg/kg; 5 animals/sex at 10000, 12600, and 15800 mg/kg. Daily observations were made for 10 days for toxic symptoms and the viscera of the test animals were examined macroscopically. Toxic symptoms included diarrhea for 1 day, reduced activity and appetite, and tremors and increasing weakness to near collapse lasting 5 to 7 days in animals of the last 3 dose groups. One female died at dose 12600 and at 15800 mg/kg. Survival time was 3 to 5 days. At autopsy there were hemorrhagic areas of the liver, lungs, and kidneys, and intestinal inflammation. Surviving animals were sacrificed 10 days after dosing. Hemorrhagic areas of the lungs were observed in a few instances; otherwise the viscera appeared normal by macroscopic examination. The oral LD50 was thus found to be > 15800 mg/kg. Based on these results and according to the EU classification criteria outlined in 67/548/EEC and 1272/2008 the substance does not have to be classified.