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Toxicological information

Acute Toxicity: inhalation

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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

Constituent 1
Chemical structure
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 triphosphate
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