Reaction mass of hexadecyl dihydrogen phosphate and dihexadecyl hydrogen phosphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug - Sept 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP conform study with design equivalent to guideline; sufficient reporting

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

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

Test material form:

solid: flakes

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, England
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 109 - 150 g
- Fasting before dosing: overnight prior to and approx. 4 h after dosing
- Housing: in groups by sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): standard laboratory rodent diet (Labsure LAD 1), ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: min. 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 62%
- Air changes (per hr): approx. 15/h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30.8. To: 13.9.1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 80% (w/v)
- Amount of vehicle (if gavage): 20 mL/kg

Doses:

16000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed soon after dosing; then at frequent intervals for the remainder of day 1. On subsequent days the animals were observed at least once in the morning and once at the end of the experimental day. Individual body weights were taken on days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (see above), body weight (see above)

Statistics:

none

Results and discussion

Preliminary study:

A trial test was carried out by dosing two male and two female rats at 16000 mg/kg bw. The results of the preliminary study indicated that the acute median lethal oral dose of the test item was in excess of 16000 mg/kg bw.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Mortality:

no mortalities occurred.

Clinical signs:

other: Piloerection only was observed in the rats treated at 16000 mg/kg bw with the test substance. A similar reaction was not seen in control animals. Recovery of test animals as judged by external appearance and behaviour was apparently complete by day 3.

Gross pathology:

No effects

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The median lethal dose of Dihexadecyl hydrogen phosphate (LD50) greater than 16000 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification requirements according to regulatory requirements.

Executive summary:

Dihexadecyl hydrogen phosphate was tested for its acute toxic properties in rats via oral route. No animal died or showed clinical symptoms/macroscopic anomalies after application of 16000 mg/kg bw.

Therefore, the median lethal dose of Dihexadecyl hydrogen phosphate (LD50) was greater than 16000 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.