Pentapotassium triphosphate

Endpoint summary

Description of key information

Acute oral toxicity: Two studies are available to assess the oral toxicity of pentapotassium triphosphate [KTPP]. Taken together the studies indicate that KTPP has a low potential for systemic toxicity following acute administration via the oral route. The acute oral median dose (LD50) was estimated to be > 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). An additional supporting study (Kamienski 1971) confirms the overall classification; however, this study is not sufficient as a stand-alone data source for this endpoint.

Acute inhalation toxicity: As part of a read-across argument a key study for pentasodium triphosphate [STPP] has been included in section 7.2.2 of this dossier. The read across key study (Jackson GC, 1988) has been conducted according to guideline EPA OPP 81-3 (Acute inhalation toxicity), and according to the principles of GLP. The acute inhalation median concentration (LC50) of the read across substance was estimated to be > 0.39 mg/L (the maximum attainable concentration) in male and female rats.

Acute dermal toxicity: Testing was waived on the basis that further in vivo testing is considered to be scientifically unjustified. In addition, a read-across study from similar substance pentasodium triphosphate supports the arguments made in the waiver.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 14 October 2009 and 04 November 2009.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of GLP inspection: 06/04/2010 Date of Signature on GLP certificate: 26/11/2009

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Animals and Animal Husbandry
Female Wistar (HsdRccHan(R)TM:WIST(R)TM) strain rats were supplied by Harlan Laboratories UK Limited, Bicester, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were eight to twelve weeks of age. The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).

The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
For the purpose of the study the test material was freshly prepared, as required, as a suspension in distilled water to give a dose level of 2000mg/kg bodyweight.

- Amount of vehicle (if gavage):
Not stated

- Justification for choice of vehicle:
Distilled water was the preferred vehicle of the test method.

- Lot/batch no. (if required):
Not stated

- Purity:
Not stated


MAXIMUM DOSE VOLUME APPLIED:
10ml/kg


DOSAGE PREPARATION (if unusual):
Not applicable

CLASS METHOD (if applicable)

- Rationale for the selection of the starting dose:
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.

Doses:

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitoredduring the study. All animals were subjected to gross necropsy.

No. of animals per sex per dose:

1 female at 2000 mg/kg
4 females at 2000 mg/kg

Control animals:

no

Details on study design:

Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.
Dose Level (mg/kg) 2000
Concentration (mg/ml) 200
Dose Volume (ml/kg) 10
Number of Rats 1 Female


In the absence of mortality at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:
Dose Level (mg/kg) 2000
Concentration (mg/ml) 200
Dose Volume (ml/kg) 10
Number of Rats 4 Female

A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.

Clinical observations were made ½, 1, 2, and 4 hours after dosing and subsequently once daily for up to fourteen days. Morbidity and mortality checks were made twice daily.

Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.

At the end of the observation period the surviving animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Preliminary study:

A sighting test at a dose level of 2000 mg/kg was performed.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal was found dead one day after dosing.

Clinical signs:

other: Hunched posture was noted in all animals. Additional signs of systemic toxicity noted were ataxia and occasional body tremors. Surviving animals appeared normal one or two days after dosing.

Gross pathology:

Individual necropsy findings are given in Table 3.
Abnormalities noted at necropsy of the animal that died during the study were abnormally red lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Table 1              Individual Clinical Observations and Mortality Data

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 Female	H	H	H	H	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-0 Female	H	HA	H	HATo	H	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-1 Female	HA	HA	H	H	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-2 Female	H	HA	H	HATo	X
	2-3 Female	HA	HA	H	H	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0= No signs of systemic toxicity

H = Hunched posture

A = Ataxia

To = Occasional body tremors

X = Animal dead

Table 2              Individual Bodyweights and Bodyweight Changes

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight (g) at Death	Bodyweight Gain (g) During Week
		0	7	14		1	2
2000	1-0 Female	178	183	194		5	11
	2-0 Female	183	186	192		3	6
	2-1 Female	156	162	173		6	11
	2-2 Female	187	-	-	177	-	-
	2-3 Female	183	193	201		10	8

-= Animal dead

 

Table 3              Individual Necropsy Findings

Dose Level mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
2000	1-0 Female	Killed Day 14	No abnormalities detected
	2-0 Female	Killed Day 14	No abnormalities detected
	2-1 Female	Killed Day 14	No abnormalities detected
	2-2 Female	Found dead Day 1	Lugs: abnormally red Liver: dark Kidneys: dark
	2-3 Female	Killed Day 14	No abnormalities detected

 

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Not classified - EU CLP).

This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation EC (No.) 1272/2008 (EU CLP). Pentapotassium triphosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).

Executive summary:

Introduction. 

The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:

OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted 17 December 2001)

Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008

Method. 

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. 

One animal was found dead one day after dosing.

Clinical Observations. 

Hunched posture was noted in all animals. Additional signs of systemic toxicity noted were ataxia and occasional body tremors. Surviving animals appeared normal one or two days after dosing.

Bodyweight. 

Surviving animals showed expected gains in bodyweight.

Necropsy. 

Abnormalities noted at necropsy of the animal that died during the study were abnormally red lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Conclusion. 

The acute oral median lethal dose (LD₅₀) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Not classified - EU CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

LD50 >2,000 mg/kg bw
The key study (Bradshaw J, 2010) has been conducted according to a current guideline (OECD 420) according to the principles of GLP. The supporting study is not sufficient as a stand-alone data source.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.

The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category

1. Both substances are inorganic salts of a monovalent cation from Group 1A of the periodic table, and triphosphoric acid. Thus, they share the Na+ or K+ cation and P3O105- anion.
2. Both the Na+ and the K+ cation have a similar biological function and therefore triphosphate salts of these types are not considered to differ in their systemic toxicity profile; differences arise in their local effects profile due to the increasing or decreasing acidity/alkalinity and buffering capacities of the substances. This has been shown not to have an effect on systemic toxicity.
3. In addition, both salts have been shown to be of similar low toxicity in acute oral studies and therefore comparisons can be drawn to allow read-across for the acute inhalation endpoint

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.

3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.

4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

not specified

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

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.

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.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test material caused no mortality when administered for 4 h to Wistar rats at a mean, maximum attainable concentration of 0.39 mg/L air. Based on this, the LC50 for the test material is considered to be greater than 0.39 mg/L. This study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement for this endpoint.

As the study was conducted up to the maximum attainable concentration and in accordance with Regulation (EC) No. 1272/2008 (EU CLP) pentasodium triphosphate is not considered to be classified.
Read across from pentasodium triphosphate to pentapotassium triphosphate is justified on the following basis:
Both substances are ionic inorganic compounds containing a triphosphate anion and a group 1 alkali metal cation. Both the Na+ and the K+ cation have a similar biological function and therefore triphosphate salts of these types are not considered to differ in their systemic toxicity profile; differences arise in their local effects profile due to the increasing or decreasing acidity/alkalinity and buffering capacities of the substances. This has been shown not to have an effect on systemic toxicity.
In addition, both salts have been shown to be of similar low toxicity in acute oral studies and therefore comparisons can be drawn to allow read-across for the acute inhalation endpoint.

This study is therefore deemed reliable for classification and labeling according to Regulation (EC) No 1272/2008 (EU CLP) and further testing is considered to be scientifically unjustified.

Reference 2

Endpoint:

acute toxicity: inhalation

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.

The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category

1. Both substances are inorganic salts of a monovalent cation from Group 1A of the periodic table, and triphosphoric acid. Thus, they share the Na+ or K+ cation and P3O105- anion.
2. Both the Na+ and the K+ cation have a similar biological function and therefore triphosphate salts of these types are not considered to differ in their systemic toxicity profile; differences arise in their local effects profile due to the increasing or decreasing acidity/alkalinity and buffering capacities of the substances. This has been shown not to have an effect on systemic toxicity.
3. In addition, both salts have been shown to be of similar low toxicity in acute oral studies and therefore comparisons can be drawn to allow read-across for the acute inhalation endpoint

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.

3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.

4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’.

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across source

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.

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.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test material caused no mortality when administered for 4 h to Wistar rats at a mean, maximum attainable concentration of 0.39 mg/L air. Based on this, the LC50 for the test material is considered to be greater than 0.39 mg/L. This study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement for this endpoint.

As the study was conducted up to the maximum attainable concentration and in accordance with Regulation (EC) No. 1272/2008 (EU CLP) pentasodium triphosphate is not considered to be classified.
Read across from pentasodium triphosphate to pentapotassium triphosphate is justified on the following basis:
Both substances are ionic inorganic compounds containing a triphosphate anion and a group 1 alkali metal cation. Both the Na+ and the K+ cation have a similar biological function and therefore triphosphate salts of these types are not considered to differ in their systemic toxicity profile; differences arise in their local effects profile due to the increasing or decreasing acidity/alkalinity and buffering capacities of the substances. This has been shown not to have an effect on systemic toxicity.
In addition, both salts have been shown to be of similar low toxicity in acute oral studies and therefore comparisons can be drawn to allow read-across for the acute inhalation endpoint.

This study is therefore deemed reliable for classification and labeling according to Regulation (EC) No 1272/2008 (EU CLP) and further testing is considered to be scientifically unjustified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

LC50 >390 mg/L
The key study (Jackson GC, 1988) has been conducted according to guideline EPA OPP 81-3 (Acute inhalation toxicity), and according to the principles of GLP. The LC50 was determined as being greater than the highest dose level.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

No study available on pentapotassium triphosphate.

Justification for classification or non-classification

Acute toxicity: oral: The acute oral median dose (LD50) of pentapotassium triphosphate [KTPP] in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).

 

Acute toxicity: inhalation: The acute inhalation median concentration (LC50) of the analogue substance pentasodium triphosphate [STPP] in male and female rats was estimated to be greater than 0.39 mg/L air. The result was achieved at the maximum attainable concentration which is considered to be equivalent to a limit test conducted at 5 mg/L and therefore STPP is considered not to be classified according to Regulation (EC) No 1272/2008 (EU CLP).

This classification can be read across to pentapotassium triphosphate on the basis of the justifications provided above (see discussion box), this study is acceptable for assessment and no further animal testing is justified.

 

Acute toxicity: dermal: Pentapotassium triphosphate is not considered to be classifed as acutely toxic via the dermal route.