Isodecyl diphenyl phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

February 1969 - March 1969

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Too concise study report, study not conducted according to an existing guideline. No GLP. Acceptable basic data.

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 test the undiluted compound was fed by stomach tube to 11 Sprague-Dawley strain albino male and female rats in increasing doses at increments of various fractional log intervals at 7 levels (1000, 2000, 3160, 5010, 7940, 12600, and 15800 mg/kg).
Observations were made for toxic signs during 9 days, surviving animals were sacrificed 9 days after dosing, and the viscera of the test animals were examined macroscopically. Finally, an LD50 was supplied.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isodecyl diphenyl phosphate

EC Number:

249-828-6

EC Name:

Isodecyl diphenyl phosphate

Cas Number:

29761-21-5

Molecular formula:

C22H31O4P

IUPAC Name:

isodecyl diphenyl phosphate

Details on test material:

- Name of test material (as cited in study report): Santicizer 148
- Physical state: colorless liqiod
- Analytical purity: confidential information
- Lot/batch No.: confidential information

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 220 to 260 g.

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

1000, 2000, 3160, 5010, 7940, 12600, and 15800 mg/kg

No. of animals per sex per dose:

At 1000, 2000, 3160, 5010, 7940, and 12600 mg/kg: 1 animal (male or female)
At 15800 mg/kg: 3 females and 2 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

No statistical analysis was performed.

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 800 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: Toxic symptoms included slight weakness in animals dosed at the two highest levels (12600 and 15800 mg/kg) for 3 to 4 days.

Gross pathology:

In all surviving animals, sacrificed 9 days after dosing, the viscera appeared normal by macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The highest dose of 15800 mg/kg was found to be non-lethal by single oral ingestion in 5 rats (3 females, 2 males), observed over a period of 9 days. The oral LD50 of Santicizer 141 is therefore greater than 15800 mg/kg bw. The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008.

Executive summary:

In this range finding acute oral toxicity test the undiluted compound was fed by stomach tube to 11 Sprague-Dawley strain albino male and female rats in increasing doses at increments of various fractional log intervals at 7 levels (1000, 2000, 3160, 5010, 7940, 12600, and 15800 mg/kg). Observations were made for toxic signs during 9 days, surviving animals were sacrificed 9 days after dosing, and the viscera of the test animals were examined macroscopically. Finally, an LD50 was supplied. Toxic symptoms included slight weakness in animals dosed at the two highest levels (12600 and 15800 mg/kg) for 3 to 4 days. No mortality occurred. All surviving animals were sacrificed 9 days after dosing. The viscera appeared normal by macroscopic examination. The oral LD50 of Santicizer 141 is greater than 15800 mg/kg bw. The substance does not have to be classified according to the EU classification criteria outlined in 67/548/EEC and 1272/2008.