Phosphoric acid, mono- and di-C16-18-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May to August 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octadecyl dihydrogen phosphate

EC Number:

220-983-1

EC Name:

Octadecyl dihydrogen phosphate

Cas Number:

2958-09-0

Molecular formula:

C18H39O4P

IUPAC Name:

octadecyl dihydrogen phosphate

Constituent 2

Reference substance name:

Hexadecyl dihydrogen phosphate

EC Number:

222-581-1

EC Name:

Hexadecyl dihydrogen phosphate

Cas Number:

3539-43-3

Molecular formula:

C16H35O4P

IUPAC Name:

hexadecyl dihydrogen phosphate

Constituent 3

Reference substance name:

Dioctadecyl hydrogen phosphate

EC Number:

221-237-8

EC Name:

Dioctadecyl hydrogen phosphate

Cas Number:

3037-89-6

Molecular formula:

C36H75O4P

IUPAC Name:

dioctadecyl hydrogen phosphate

Constituent 4

Reference substance name:

Dihexadecyl hydrogen phosphate

EC Number:

218-594-7

EC Name:

Dihexadecyl hydrogen phosphate

Cas Number:

2197-63-9

Molecular formula:

C32H67O4P

IUPAC Name:

dihexadecyl hydrogen phosphate

Constituent 5

Reference substance name:

hexadecyl octadecyl hydrogen phosphate

Cas Number:

93803-11-3

Molecular formula:

C34H71O4P

IUPAC Name:

hexadecyl octadecyl hydrogen phosphate

impurity 1

Reference substance name:

Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.

Molecular formula:

N/A

IUPAC Name:

Unidentified impurities, likely the C16 and C18, and mixed C16/C18 trialkyl phosphates based 31P NMR chemical shift.

Test material form:

solid

Details on test material:

CAS Number 39471-52-8

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Animals were nulliparous and non-pregnant
Acclimatization; at least 5 days
Animals age: 8 to 12 weeks
Body weight: No variation greater than ±20% body weight
Animal housing: Suspended solid-floor polypropylene cages, groups of 4 animals in each cage.
Free access to water and food.
Temperature: 19 to 25ºC
Humidity: 30 to 70%

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Single dose by oral gavage, volume administered to each animal according to the fasted body weight.

Doses:

1 dose at 2,000 mg/kg

No. of animals per sex per dose:

1animal at 300 mg/kg for pre-liminary test
5 animals per dose level

Control animals:

no

Details on study design:

A total of 5 animals were treated at a dose level of 2,000 mg/kg in the study.
All animals were dosed once by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dosed animals.
Clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0, Day 7 and Day 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subject to gross pathology and this consisted of an external examination and opening of the abdominal and thoracic cavities.
The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Preliminary study:

300 mg/kg on pre-liminary test
Mortality: There was no mortality
Clinical signs: No signs of systematic toxicity were noted in the observation period.
Body weight: The animal showed expected gains in body weight over the observation period.
Gross pathology: No abnormalities were noted at necropsy.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: No signs of systematic toxicity were noted in the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat is greater than 2,000 mg/kg bw .