Octylphosphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Similar to guideline study without GLP, in female rats only

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:

1979

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: female rats only used

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

study performed before GLP statement

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octylphosphonic acid

EC Number:

225-218-5

EC Name:

Octylphosphonic acid

Cas Number:

4724-48-5

Molecular formula:

C8H19O3P

IUPAC Name:

octylphosphonic acid

Test material form:

other: Waxy solid

Details on test material:

Name in study report: (Trade Name) / Oktanphosphonsäure

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain Wistar Hoe WISKf (SPF71)
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 118-218 g
- Fasting period before study: 16 hours before and 2 hours after dosing
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: from 18 October to 19 November 1978 and from 10 to 25 May 1979 (study interrupted by verbal cancellation).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

No data

Doses:

1000, 1600, 2000, 3150, 5000 mg/kg

No. of animals per sex per dose:

10/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- 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:

female

Dose descriptor:

LD50

Effect level:

1 890 mg/kg bw

Based on:

test mat.

95% CL:

1 650 - 2 340

Mortality:

1000 0/10
1600 2/10
2000 6/10
3150 10/10
5000 10/10

Clinical signs:

other: passivity, prone or side position, creeping gait, partially closed eyes, noisy, irregular or increased rate of respiration, decreased pupillary reflex, rough coat and increased heart rate.

Gross pathology:

Macroscopic examination of the decedents showed thickening of the stomach, stomach ruptured, substance in the abdominal cavity, suprarenal bodies discoloured dark-red/brown, reddened gastric mucosa.
No macroscopic effects were seen in survivors.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

other: Classified as harmful as per the CLP Regulation EC No 1272/2008

Conclusions:

Under the test conditions of this study, the acute oral median lethal dose (LD50) of the test material in female Wistar rats was found to be 1890 mg/kg bodyweight. Under the test conditions of this study, OPA is classified into category 4, H302 according to the regulation (EC) N°.1272/2008 and as Xn, R22 according to the Directive 67/548/EEC.

Executive summary:

A study was performed to assess the acute oral toxicity of the test material in female Wistar rats. Groups of ten fasted animals were given a single oral dose of test material, as a 25% solution in water at dose levels of 1000, 1600, 2000, 3150 and 5000 mg/kg bodyweight. The animals were observed for fourteen days after dosing and were then killed for gross pathological examination.

 

Deaths occurred at 1600 mg/kg and above. Clinical signs observed were passivity, prone or side position, creeping gait, partially closed eyes, noisy, irregular or increased rate of respiration, decreased pupillary reflex, rough coat and increased heart rate. Surviving animals showed expected gain in bodyweight during the study. Macroscopic examination of the decedents showed thickening of the stomach, stomach ruptured, substance in the abdominal cavity, suprarenal bodies discolored dark-red/brown, reddened gastric mucosa. No macroscopic effects were seen in survivors.

 

The acute oral median lethal dose (LD50) of the test material in female Wistar rats was calculated as 1890 (1650-2340) mg/kg bodyweight.

Under the test conditions of this study, OPA is classified into category 4, H302 according to the regulation (EC) N°.1272/2008 and as Xn, R22 according to the Directive 67/548/EEC.

 

This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study in the rats.