Dodecylphosphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16/11/2015 to 25/02/2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study following OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2015-04-06

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecylphosphonic acid

EC Number:

225-897-8

EC Name:

Dodecylphosphonic acid

Cas Number:

5137-70-2

Molecular formula:

C12H27O3P

IUPAC Name:

dodecylphosphonic acid

Test material form:

solid

Remarks:

Waxy solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: 9-10 weeks old
- Weight at study initiation: 202 – 237 g
- Fasting period before study: yes all the night before treatment
- Housing: 3 animals / cage
- Cage type: type II polypropylene/polycarbonate
- Cage sizes:Hight: 18 cm, length: 38 cm, width: 23 cm

- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany (Batch no.: 575 4308, expiry date: March 2016), ad libitum, except for the night before treatment.
- Water (e.g. ad libitum): Tap water from the municipal supply, as for human consumption from a 500 ml bottle, ad libitum.
- Acclimation period: 19-20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 – 24.0°C
- Humidity (%): 30 – 58 %
- Air changes (per hr): 15 – 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL /kg
- Lot/batch no. (if required): 6820914

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): The test item was freshly formulated at a concentration of 200 mg/mL in the vehicle, in the Pharmacy of CiToxLAB Hungary Ltd. on the day of administration. The formulation container was magnetic stirred continuously up to the end of dose administration procedures.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 groups of three female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter
- Frequency of weighing: on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination

Statistics:

Not applicable

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Dodecylphosphonic acid did not cause mortality at a dose level of 2000 mg/kg bw.

Clinical signs:

other: Acute oral administration of Dodecylphosphonic acid did not cause any test item related effect

Gross pathology:

There was no evidence of the macroscopic observations at a dose level of
2000 mg/kg bw

Other findings:

Not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item Dodecylphosphonic acid was found to be above 2000 mg/kg bw in female Crl:WI rats.

Executive summary:

 

A study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat according to OECD 403 and in compliance with GLP. Two groups of three fasted animals (females) were given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.

There were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No other abnormalities were noted at necropsy.

 

The acute oral median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Therefore, no classification is required according to the regulation (EC) N°1272/2008.