Pentasodium triphosphate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed to GLP and guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium triphosphate

EC Number:

231-838-7

EC Name:

Pentasodium triphosphate

Cas Number:

7758-29-4

Molecular formula:

H5O10P3.5Na

IUPAC Name:

pentasodium bis(phosphonatooxy)phosphinate

Details on test material:

- Name of test material (as cited in study report): Sodium tripolyphosphate
- Substance type: White powder
- Purity: >90%
- Lot/batch No.: B5885327C

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK Limited, Kent, UK
- Weight at study initiation: ~ 200 g
- Housing: Cages were made of polypropylene (size 38 cm x 56 cm x 18 cm height) and had detachable wire mesh tops and floors
- Diet: Free access to a measured excess amount of food (Labsure LAD 1)
- Water: Free access to water
- Acclimation period: At least 5 days prior to exposure

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Max (23) Min (19)
- Humidity (%): 63

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A Wright dust generator
- Exposure chamber volume: 120 L
- Method of holding animals in test chamber: Rats were held in cages of stainless steel mesh partitioned to provide 10 individual animal compartments
- Method of conditioning air: The test atmosphere produced by the generator was passed through a glass elutriation column to reduce, by sedimentation the amount of non-respirable particulate.
- Method of particle size determination: Anderson mini-sampler
- Temperature in air chamber: Mean air temperature: 23.2°C(control) 22.6 °C (test).
- Relative humidity in air chamber: Mean relative humidity: 39% (control) 41% (test)

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0.39 mg/L (highest attainable concentrations)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighed daily until the end of the observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, lung weights:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.39 mg/L air

Exp. duration:

4 h

Mortality:

There were no deaths

Clinical signs:

other: During exposure: signs consistent with exposure to an irritant dust. Partial closing of the eye, exaggerated respiratory movements, restless behaviour and excessive grooming were seen in all exposed rats. During observation period: There were no clinical

Body weight:

Small losses in body weight or a decrease in the rate of body weight gain were observed for a proportion of male rats on the day following exposure. The losses in the male rats were statistically significant 9P<0.05)

Gross pathology:

The lung weight to body weight ratio for all rats was within normal limits. Grey areas were seen ion the lungs of 1 male rat exposed to the test substance. There were no abnormalities in any other rats.

Other findings:

Food and water consumption: Food consumption was reduced for 1 day in male rats and slightly reduced for 1 day in female rats following exposure. Water consumption was slightly reduced for 1 day in male rats following exposure.

Any other information on results incl. tables

Table 1: Concentrations of sodium tripolyphosphate (Gravimetric determination):

Sample	Time	Amount in air (mg/L)
2.1	0 h:30 m	0.53
2.2	1h:00m	0.50
2.3	2h:00m	0.35
2.4	3h:00m	0.29
2.5	3h:50m	0.27
	Mean	0.39
	SD	0.120

The mean concentration of sodium tripolyphosphate was 0.39 mg/L and was the highest attainable. The concentration achieved indictaes that the test susbstance contains only a low proportion of small particles.

Table 2: Particle size distribution of sodium tripolyphosphate:

Sample	Time	Stage	Particle size range (µm)	Amount collected (mg)	% of total	% respirable
PSD 1	1h:30m	1	>5.5	1.00	64.9	35.1
		2	3.5-5.5	0.16	10.4
		3	2.0-3.5	0.20	13.0
		4	0.3-2.0	0.10	6.5
		Filter	0.3	0.08	5.2
			Totals	1.54	100.0
PSD 2	3 h:30m	1	>5.5	0.64	81.0	19.0
		2	3.5-5.5	0.02	2.5
		3	2.0-3.5	0.09	11.4
		4	0.3-2.0	0.04	5.1
		Filter	0.3	0.00	0.0
			Totals	0.79	100.0

The results in table 2 show that on average 27% of the dust collected was 5.5 µm or less in aerodynamic diameter and therefore of respirable size.

Applicant's summary and conclusion

Conclusions:

4 h LC50: > 0.39 mg/L air