Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key studies are available for acute oral and acute inhalation toxicity. These studies are performed under the conditions of GLP and to an appropriate OECD guideline. As such, these studies are considered to be adequate and reliable for use as key studies for the purpose of REACH Registration and classification and labelling in accordance with EU CLP. It is not considered necessary to provide acute dermal toxicity data.

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:
From 08 January 2015 to 11 February 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conclusive, performed to a valid guideline (OECD TG 420, adopted 17 December 2001) and was conducted under GLP conditions. No deviations from the test methods were noted.
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: 12 to 14 March 2014 Date of Signature on Certificate: 12 May 2014
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 145-168g
- Fasting period before study: Overnight
- Housing: In groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK provided ad libitum
- Water (e.g. ad libitum): Mains drinking water provided ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): At least fifteen
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: The test item did not dissolve/suspend in distilled water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual):
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The available information on the toxicity of the test item was used to select 2000 mg/kg as the starting dose
Doses:
300 mg/kg, 2000 mg/kg
No. of animals per sex per dose:
Five animals per dose.

Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2 and 4 hours after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes
Preliminary study:
Individual clinical observations and mortality data are given in Table 1. One animal was killed for humane reasons, 30 minutes after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. One other animal was found dead 2 days after dosing. increased respiratory rate, labored respiration, prostration and tiptoe gait.
Surviving animals appeared normal 1 or 2 days after dosing. Individual necropsy findings are given in Table 3.
Abnormalities noted at necropsy of the animals that died or was humanely killed during the study were dark liver or patchy pallor of the liver, dark kidneys, gaseous stomach and hemorrhagic non-glandular epithelium of the stomach and/or hemorrhagic gastric mucosa.
No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 300 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Individual clinical observations and mortality data are given in Table 4. There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
Individual body weights and body weight changes are given in Table 5. All animals showed expected gains in body weight over the observation period.
Gross pathology:
Individual necropsy findings are given in Table 6.
No abnormalities were noted at necropsy.

Table 1:Individual Clinical Observations and Mortality Data - 2000 mg/kg

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

0

0

0

H

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2-0 Female

RlRdPrX*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2-1 Female

HLa

HLPWt

HWt

HPRl

HWt

0

0

0

0

0

0

0

0

0

0

0

0

0

2-2 Female

HA

HA

HA

HP

HWt

0

0

0

0

0

0

0

0

0

0

0

0

0

2-3 Female

HA

HAWt

HWt

HPWt

HPPtRlRi

X

 

 

 

 

 

 

 

 

 

 

 

 

0 = No signs of systemic toxicity H = Hunched posture A = Ataxia L = Lethargy Pt = Ptosis P = Pilo-erection

Ri = Increased respiratory rate Rl = Labored respiration Pr = Prostration Wt = Tiptoe gait X = Animal dead

X* = One animal was killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence 

Table 2:Individual Body Weights and Body Weight Changes - 2000 mg/kg

Dose Level mg/kg

Animal Number and Sex

Body Weight (g) at Day

Body Weight (g) at Death

Body Weight Gain (g) During Week

0

7

14

1

2

 

 

2000

1-0 Female

160

189

195

-

29

6

2-0 Female

165

-

-

162

-

-

2-1 Female

168

184

207

 

16

23

2-2 Female

161

180

196

 

19

16

2-3 Female

153

-

-

137

-

-

- = Animal dead 

Table 3:Individual Necropsy Findings - 2000 mg/kg

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

Humanely killed Day 0

Liver: patchy pallor

Kidneys: dark

Stomach: gaseous

Gastric mucosa: hemorrhagic

2-1 Female

Killed Day 14

No abnormalities detected

2-2 Female

Killed Day 14

No abnormalities detected

2-3 Female

Found dead Day 2

Liver: dark

Kidneys: dark

Stomach: gaseous

Gastric mucosa: hemorrhagic

Non-glandular epithelium of the stomach: hemorrhagic

 

Table 4:Individual Clinical Observations and Mortality Data - 300 mg/kg

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

 

 

300

3-0 Female

0

0

0

H

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-0 Female

0

0

0

H

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-1 Female

0

0

0

H

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-2 Female

0

0

0

H

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4-3 Female

0

0

0

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 L = Lethargy Pt = Ptosis P = Pilo-erection

Ri = Increased respiratory rate Rl = Labored respiration Pr = Prostration Wt = Tiptoe gait X = Animal dead

X* = One animal was killed for humane reasons due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence 

 

Table 5:Individual Body Weights and Body Weight Changes - 300 mg/kg

Dose Level mg/kg

Animal Number and Sex

Body Weight (g) at Day

Body Weight Gain (g) During Week

0

7

14

1

2

 

 

300

3-0 Female

167

182

193

15

11

4-0 Female

187

205

212

18

7

4-1 Female

189

211

222

22

11

4-2 Female

181

199

204

18

5

4-3 Female

190

211

221

21

10

- = Animal dead 

Table 6:Individual Necropsy Findings - 300 mg/kg

Dose Level mg/kg

Animal Number and Sex

Time of Death

Macroscopic Observations

 

 

300

3-0 Female

Killed Day 14

No abnormalities detected

4-0 Female

Killed Day 14

No abnormalities detected

4-1 Female

Killed Day 14

No abnormalities detected

4-2 Female

Killed Day 14

No abnormalities detected

4-3 Female

Killed Day 14

No abnormalities detected

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4).

The test item was also classified as Category 4 according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. It is reasonable to assume that the Signal Word “Warning” and the Hazard Statement “H302: Harmful if swallowed” are therefore required.
Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

Methods

Following a sighting test at a dose level of 2000 mg/kg, a group of four fasted animals was given a single oral dose of test item at the same dose level. Based on the results from this dose level an additional animal was treated with the test item at a dose level of 300 mg/kg body weight. Based on the results from this animal, a further group of four fasted animals was given a single oral dose of test item at a dose level of 300 mg/kg body weight.

The test item was administered orally as a suspension in arachis oil BP. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

Results

Mortality. One animal treated at a dose level of 2000 mg/kg was killed for humane reasons, 30 minutes after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit set forth in the UK Home Office Project Licence. One other animal treated at a dose level of 2000 mg/kg was found dead 2 days after dosing. There were no deaths at a dose level of 300 mg/kg.

Clinical Observations. Signs of systemic toxicity noted at a dose level of 2000 mg/kg were hunched posture, ataxia, lethargy, pilo-erection, ptosis, increased respiratory rate, labored respiration, prostration and tiptoe gait. Surviving animals treated at a dose level of 2000 mg/kg appeared normal 1 or 2 days after dosing. There were no signs of systemic toxicity at a dose level of 300 mg/kg.

Body Weight. Surviving animals showed expected gains in body weight.

Necropsy. Abnormalities noted at necropsy of the animals that died or was humanely killed during the study were dark liver or patchy pallor of the liver, dark kidneys, gaseous stomach and hemorrhagic non-glandular epithelium of the stomach and/or hemorrhagic gastric mucosa. 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 item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System  Category 4). The test item was also classified as Category 4 according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. It is reasonable to assume that the Signal Word “Warning” and the Hazard Statement “H302: Harmful if swallowed” are therefore required.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
300 mg/kg bw
Quality of whole database:
One study is available to assess the acute oral toxicity of ammonium polyphosphate. The key study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint. In addition, the data is considered to be adequate and reliable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 29 October 2014 to 09 December 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with an accepted guideline (OECD TG 436) and under the conditions of GLP. No deficiencies are noted and the results are considered to be relaible.
Qualifier:
according to guideline
Guideline:
OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.52 (Acute Inhalation Toxicity - Acute Toxic Class Method, 2014)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of Inspection: 12 to 14 March 2014 Date of Signature on Certificate: 12 May 2014
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: Eight to twelve weeks
- Weight at study initiation: 200-350 g
- Fasting period before study: None
- Housing: Solid-floor polypropylene cages with stainless steel lids, furnished with softwood flakes (Datesand Ltd., Cheshire , UK) and provided with environmental enrichment items: wooden chew blocks and cardboard "fun tunnels" (DatesandLtd., Cheshire)
- Diet (e.g. ad libitum): Harlan 2014C Rodent Diet, Harlan Laboratories, UK Ltd., Oxon, UK provided ad libitum
- Water (e.g. ad libitum): Mains drinking water provided ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): At least 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light (06:00 to 18:00)

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A glass concentric jet nebuliser (Radleys, Saffron Walden, Essex, UK) was located at the top of exposure chamber. The nebuliser was connected to a plastic syringe attached to an infusion pump, which provided a continuous supply of test item under pressure, and to a metered compressed air supply.
- Exposure chamber volume: Approximately 30 litres (dimensions: 28 cm diameter x 50 cm high)
- Method of holding animals in test chamber: Each rat was individually held in a tapered, polycarbonate resin restraining tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber 'O' ring.
- Source and rate of air: Compressed air was supplied by means of an oil free compressor; the chamber flow rate was maintained at 60 L/min providing 120 air changes per hour
- Method of conditioning air: Passed through a water trap and respiratory quality filters
- System of generating particulates/aerosols: Nebuliser
- Method of particle size determination:
The particle size of the generated atmosphere inside the exposure chamber was determined three times during the exposure period during a Marple Personal Cascade Impactor (Westech IS Ltd, Beds., UK). This device consisted of six impactor stages (8.4, 7.3, 3.6, 1.3, 0.94, and 0.43 µm cut points) with stainless steel collection substrates and a backup glass fibre filter, housed in an aluminium sampler. The sampler was temporarily sealed in a sampling port in the animals' breathing zone and a suitable, known volume of exposure chamber air was drawn through it using a vacuum pump. The collection substrates and backup filter were weighed before and after sampling and the weight of test item, collected at each stage, calculated by difference. The mean amount for each stage was used to determine the cumulative amount below each cut-off point size. In this way, the proportion (%) of aerosol less than 8.4, 7.3, 3.6, 1.3, 0.94 and 0.43 µm was calculated.
- Treatment of exhaust air: The extract from the exposure chamber passed through a 'scrubber' trap and was connected with a high efficiency filter to a metered exhaust system.
- Temperature, humidity, pressure in air chamber: The tempreature and relative humidity inside the exposure chamber was measured by an electronic thermometer/humidity meter (Hanna Instruments Ltd., Beds., UK) located in a vacant port in the animals' breathing zone of the chamber and recorded every thirty minutes throughout the four-hour exposure period.
- Oxgen concentration in air chamber: Oxygen levels were measured by an electronic oxygen analyser (Servomex (UK) Ltd, Crowborough, East Sussex) located in a port in the animals breathing zone during the four-hour exposure period. The test atmosphere was generated to contain at least 19% oxygen.

TEST ATMOSPHERE
- Brief description of analytical method used: During the characterisation phase of the study the test atmosphere was sampled twice and filter samples were then submitted for chemical analysis to determine if the original test item was similar to the composition of the airborne test item. A standard and samples were analysed spectrophotometrically using the following conditions:

Spectrophotometer: Camspec M550
Wavelength: 190-700 mm
Cell path length: 1 cm
Reference medium: water

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Target concentrated of 5.0 mg/L. Mean achieved atmosphere concentration: 4.85 mg/L - 97% of target.
No. of animals per sex per dose:
3 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical signs were made at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exppsure and subsequently once daily for up to fourteen days.
Individual body weights were recorded on arrival, prior to treatment on the day of exposure and on Days 1,3, 7 and 14 or at death.
- Necropsy of survivors performed: Yes
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.85 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
0/3 males died and 1/3 females died.
Clinical signs:
other: Individual clinical observations are given in Table 1 and 2. Signs of hunched posture and pilo-erection are commonly seen in animals for short periods on removal from the chamber following 4-hour inhalation studies. Wet fur is commonly recorded both duri
Body weight:
Individual body weights, together with body weight changes, are given in Table 3.

All animals exhibited body weight losses on the first day post-exposure. Two males and two female animals exhibited further body weight losses from Days 1 to 3 post-exposure. Body weight gains were noted in all surviving aimals during the remainder of the recovery period.
Gross pathology:
Individual necropsy findings are given in Table 4.

No macroscopic abnormalities were detected amongst animals that survived until the end of the recovery period at necropsy.

The following macroscopic abnormalities were detected at necropsy in the female animal that was humanely killed during the course of the study.

Liver - pale and accentuated lobular pattern
Stomach - gaseous distension
Small intestine - gaseous distension
Large intestine - gaseous distension

Key to clinical observations

Da = distended abdomen

Dh = dehydration

H = hunched posture

P = pilo-erection

Rd = decreased respiratory rate

Rg = gasping respiration

Ri = increased respiratory rate

Rl = labored respiration

Rn = noisy respiration

Wf = wet fur

X* = animal killed in extremis

0 = no abnormalities detected

Table 1: Individual clinical observations (day of exposure)

Mean achieved atmosphere concentration (mg/L)

Animal number and sex

Hours During Exposure

On removal from chamber

One hour post-exposure

 

1

 

2

 

3

 

 

4.85

1 Male

Wf

Wf

Wf

Wf H P Ri

Wf H P Ri

2 Male

Wf

Wf

Wf

Wf H P Ri

Wf H P Ri

3 Male

Wf

Wf

Wf

Wf H P Ri

Wf H P Ri

4 Female

Wf

Wf

Wf

Wf H P Ri

Wf H P Ri

5 Female

Wf

Wf

Wf

Wf H P Ri Rn Rg

Wf H P Ri Rn Rg

6 Female

Wf

Wf

Wf

Wf H P Ri

Wf H P Ri

Table 2: Individual clinical observations (recovery period)

Mean achieved atmosphere concentration (mg/L)

Animal number and sex

Days Post Exposure

 

1

 

2

 

3

 

4

 

 

5

 

 

6

 

7

 

8-14

 

 

4.85

1 Male

H P Ri

H P Ri

H P Ri

H Ri

H Ri

H

0

0

2 Male

H P Ri

H P Ri

H

H

H

H

0

0

3 Male

H P Ri

H P Ri

H P Ri

H Ri

H Ri

H

0

0

4 Female

H P Ri

H P Ri

H Ri

H Ri

H Ri

Ri

0

0

5 Female

H P Rd Rl Rn Rg

H P Ri Rn

H P Rd Rl Rn Rg Da Dh X*

 

 

 

 

 

6 Female

H P Ri

H P Ri

H Ri

H Ri

H Ri

Ri

0

0

Table 3 Individual Body Weights

Mean Achieved Atmosphere Concentration (mg/L)

Animal Number and Sex

Body Weight (g) on Day:

Increment (g) During Days:

 

-20

 

0

 

1

 

3

 

7

 

14

 

At Death

 

-20-0

 

0-1

 

1-3

 

3-7

 

7-14

 

 

0.54

1 Male

200

296

270

254

262

281

 

96

-26

-16

8

19

2 Male

206

298

273

284

300

349

 

92

-25

11

16

49

3 Male

204

299

267

254

270

307

 

95

-32

-13

16

37

4 Female

208

219

202

201

208

222

 

11

-17

-1

7

14

5 Female

206

238

212

187

-

-

187

32

-26

-25

-

-

6 Female

207

247

217

220

241

244

 

40

-30

3

21

3

Table 4 Individual Necropsy Findings

Mean Achieved Atmosphere Concentration (mg/L)

Macroscopic Observations

Animal Number and Sex

1 Male

2 Male

3 Male

4 Female

5* Female

6 Female

 

 

4.85

Liver: Pale

          Accentuated                                                   lobular pattern

 

 

 

 

P

P

 

Stomach: Gaseous distension

 

 

 

 

P

 

Small intestine: Gaseous distension

 

 

 

 

P

 

Large intestine: Gaseous distension

 

 

 

 

P

 

 

N

N

N

N

 

N

P = finding present

N = no abnormalities detected

* = Animal humanely killed during study

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
One death occurred in a group of six rats exposed to a mean achieved atmosphere concentration of 4.85 mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration ( 4 hr LC50) of polyphosphoric acids, ammonium salts (liquid) in the RccHan™: WIST strain rat, was greater than 4.85 mg/L. In accordance with Regulation (EC) No. 1272/2008 (EU CLP) ammonium polyphosphate is not considered to be classified as acutely toxic via the inhalation route.

The test item did not meet the criteria for classification according to Regulation (EC) No. 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

According to the criteria of classification of GHS (Globally Harmonised Classification System) the substance is classified in Acute Toxicity Inhalation Category 5 due to the mortality and clinical signs observed in one animal.
Executive summary:

A study was performed to assess the acute inhalation toxicity of the test item. The method used was designed to be compatible with that described in the OECD Guideline for Testing of Chemicals (2009) No. 436 "Acute Inhalation Toxicity - Acute Toxic Class Method" and Method B.52 Acute Inhalation Toxicity - Acute Toxic Class Method, 2014, of Commission Regulation (EC) No. 440/2008.

A group of six RccHan™: WIST strain rats (three males and three females) was exposed to an aerosol atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period.

The mean achieved atmospheric concentration was as follows:

Atmosphere Concentration

Mean Achieved (mg/L)

Standard deviation

Nominal (mg/L)

4.85

0.48

42.9

The characteristics of the achieved atmosphere were as follows:

Mean Achieved Atmosphere Concentration (mg/L)

Mass Median Aerodynamic Diameter (µm)

Inhalable Fraction (% < 4µm)

Geometric Standard Deviation

4.85

2.48

72.7

2.22

The mortality data were summarised as follows:

Mean achieved atmosphere concentration (mg/L)

Deaths

Male

Female

Total

4.85

0/3

1/3

1/6

Clinical observations

Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection and wet fur. One animal also exhibited decreased respiratory rate, labored respiration, gasped respiration, noisy respiration, dehydration and a distended abdomen. Surviving animals recovered to appear normal on Day 7 post-exposure.

Body weight

All animals exhibited body weight losses on the first day post-exposure. Two males and two female animals exhibited further body weight losses from Days 1 to 3 post-exposure. Body weight gains were noted in all surviving animals during the remainder of the recovery period.

Necropsy

No macroscopic abnormalities were detected amongst animals that survived until the end of the recovery period at necropsy.

The following macroscopic abnormalities were detected at necropsy in the female animal that was humanely killed during the course of the study:

Liver - pale and accentuated lobular pattern;

Stomach - gaseous distension;

Small intestine - gaseous distension;

Large intestine - gaseous distension.

The 4 hr LC50 was considered to be greater than 4.85 mg/L.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
4 850 mg/m³
Quality of whole database:
One key study is available to assess the acute inhalation toxicity of ammonium polyphosphate. This study was performed on the liquid product as this is the form that is placed on the EU market. The key study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint. In addition, the data is considered to be adequate and reliable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP).

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Data are provided on the acute oral toxicity of solid ammonium phosphate (anhydrous) and the acute inhalation toxicity of ammonium polyphosphate, liquid (hydrated form placed on the EU market). It was deemed appropriate to perform the acute inhalation study on the liquid form as inhalation of liquid droplets during spray applications was deemed to be a major route of exposure for the material as the solid form of the substance is not placed on the EU market.


Justification for selection of acute toxicity – oral endpoint
This study is conducted according to an appropriate guideline (OECD 423) and under the conditions of GLP.

Justification for selection of acute toxicity – inhalation endpoint
This study is conducted according to an appropriate guideline (OECD 436) and under the conditions of GLP.

Justification for selection of acute toxicity – dermal endpoint
No study available.

Justification for classification or non-classification

Acute oral toxicity:The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight. Therefore ammonium polyphosphate is classified as acute toxicity category 4 with the hazard statement 'H302: Harmful if swallowed'.

Acute inhalation toxicity:The acute inhalation median lethal concentration (4 hr LC50) of polyphosphoric acids, ammonium salts (liquid) in the RccHan™: WIST strain rat, was determined to be > 4.85 mg/L.Therefore in accordance with Regulation (EC) No. 1272/2008 (EU CLP)ammonium polyphosphate is not classified for acute inhalation toxicity. 

 

Acute dermal toxicity:There are no data to suggest that ammonium polyphosphate is classified for acute dermal toxicity and therefore no classification is proposed.

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