Phosphonic acid, monoethyl ester, sodium salt (1:1)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 Oct - 10 Nov 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

(adopted in 1981)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

2009

Deviations:

yes

Remarks:

Geometric standard deviation outside the recommended range (1.5-3.0)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Test guideline 4

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium triethyl triphosphonate

EC Number:

254-320-2

EC Name:

Aluminium triethyl triphosphonate

Cas Number:

39148-24-8

Molecular formula:

C2H7O3P.1/3Al

IUPAC Name:

aluminum tris(ethyl phosphonate)

Test animals

Species:

rat

Strain:

other: Sprague-Dawley Crl:CD ® BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: approx. 8 - 10 weeks
- Weight at study initiation: 271 - 301 g (males), 222 - 237 g (females)
- Housing: 5 animals of the same sex per cage in stainless steel lids, furnished with soft wood flakes (Dates and Ltd., Cheshire, UK)
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, Essex, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

2.4 µm

Geometric standard deviation (GSD):

0.33

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindric exposure chamber
- Exposure chamber volume: 30 L
- Method of holding animals in test chamber: each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber O-ring
- Source of air: compressed air (passed through a water trap and respiratory quality filters)
- System of generating particulates/aerosols: Wright's Dust Feed mechanism driven by a variable speed motor
- Method of particle size determination: cascade impactor (six impactor stages with stainless steel collection substrates (10, 6, 3.5, 1.6, 0.9 and 0.5 µm cut-off points) and a back up glass fibre filter housed in an aluminium sampler)
- Treatment of exhaust air: filtered
- Temperature and humidity: 20 ± 1°C and 46 ± 3%

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrical analysis (chamber concentrations were determined at regular intervals during the exposure period using glass fibre filters (Gelman type A/E 25 mm) placed in filter holders temporarily sealed in a vacant port in the exposure chamber)
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: please refer to Table 1 under "Any other information on materials and methods incl. tables"
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.4 µm / 0.33 µm

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: based on the expected low toxicity of the test item, a nominal test concentration of 5 mg/L was selected in accordance to the limit concentration defined in OECD Guideline 403.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

4 h

Concentrations:

5 mg/L (nominal concentration)
5.11 mg/L (analytical concentration)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and thereafter once daily. Individual body weights were recorded prior to treatment and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: behavioural observations

Statistics:

Mean values and standard errors were calculated from the examined parameters.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.11 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occured during the exposure and observation period.

Clinical signs:

other: During the exposure period, animals showed signs of wet fur (10/10), laboured respiration (5/5 males, 1/5 females) and a decreased respiration rate (3/5 males and females). Immediately after removal of the chamber, all animals revealed wet fur, hunched po

Body weight:

A possible reduction in body weight gain was observed in male animals during the first week of the 14 day observation period: body weight increased around 16 - 23 or 3 - 19 g during week 1 in male and female animals, respectively. Afterwards, increases around 26 - 57 or 4 - 18 g were determined during week 2 in males and females, respectively.

Gross pathology:

No abnormalities were observed in exposed animals except dark red foci on the lungs of 3/5 males and 1/5 females.

Any other information on results incl. tables

Table 2. Acute inhalation toxicity of Fosetyl Al.

 

Target concentration [mg/L air, analytical]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Males
5.11	0/5/5	Day 0 - 4 (longest)	---	0
Females
5.11	0/5/5	Day 0 - 2	---	0
LC50 > 5.11 mg/L air

                                                                                           

* first number = number of dead animals                                 

 second number = number of animals with clinical signs         

 third number = number of animals used

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions chosen, no mortality was observed. Thus, the LC50 was determined to be greater than 5.11 mg/L air.