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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 May - 21 Jun 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminium metaphosphate
EC Number:
237-415-3
EC Name:
Aluminium metaphosphate
Cas Number:
13776-88-0
Molecular formula:
Al.3HO3P
IUPAC Name:
aluminium metaphosphate
Details on test material:
- Name of test material (as cited in study report): Aluminium metaphosphate
- Physical state: white solid powder
- Analytical purity: >95%

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Weight at study initiation: 190-250 g
- Fasting period before study: 3 h
- Housing: single-caged
- Diet: Common diet (pellets, ssniff Spezialdiäten GmbH, Germany), ad libitum
- Water: Tap water (drinking quality), ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 1 mL/100 g bw

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A starting dose level of 300 mg/kg bw was used which is recommended in OECD 423 for animal welfare reasons when no toxicological information on the substance to be tested is available.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
control group: 3
test groups: 6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weight of all animals was determined at test start, 1 week after test start and at test end. The animals were observed daily for clinical symptoms.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Control group: no mortality occurred
300 mg/kg bw: 1/6 animals died on Day 2
2000 mg/kg bw: no mortality occurred
Clinical signs:
other: Control group: no clinical signs of toxicity were observed. 300 mg/kg bw: 1/6 animals showed left forelimb in relieving posture at 0-4 h post-treatment. The same animal showed intense swelling of the left forelimb prior to death on Day 2. 2000 mg/kg bw: n
Gross pathology:
Control group: there were no abnormal findings at gross necropsy.
300 mg/kg bw: macroscopic findings in the animal found death on Day 2 included: perforation of the oesophagus (ca. 4 mm); rectum faeces not formed; moderate congestion hyperaemia in the spleen, liver and kidneys; high-grade congestion hyperaemia in the heart; moderate congestion hyperaemia, different blood distribution and low-grade oedema and emphysema in the lung.
2000 mg/kg bw: there were no abnormal findings at gross necropsy.

Any other information on results incl. tables

Table 1. Summary of mortality and clinical signs.

Dose level (mg/kg bw)

Animal number

Observation period

0-4 h

Day 1-14

Mortality

Clinical signs

Mortality

Clinical signs

Control

1

no

NAD

no

NAD

2

no

NAD

no

NAD

3

no

NAD

no

NAD

300

1

no

NAD

no

NAD

2

no

(1)

yes, Day 2

(2)

3

no

NAD

no

NAD

4

no

NAD

no

NAD

5

no

NAD

no

NAD

6

no

NAD

no

NAD

2000

1

no

NAD

no

NAD

2

no

NAD

no

NAD

3

no

NAD

no

NAD

4

no

NAD

no

NAD

5

no

NAD

no

NAD

6

no

NAD

no

NAD

 

NAD: no abnormality detected

(1): left forelimb in relieving posture

(2): intense swelling of left forelimb

 

Table 2. Summary of body weight (gain).

Dose level (mg/kg bw)

Animal number

Body weight (gain) (g)

Day 0

Day 7

Day 0-7

Day 14

Day 0-14

Control

1

197.7

214.5

16.8

206.3

8.6

2

209.8

229.6

19.8

237.3

27.5

3

201.6

221.2

19.6

235.7

34.1

300

1

195.5

218.8

23.3

225.8

30.3

2

216.5

-

-

-

-

3

219.2

242.3

23.1

255.4

36.2

4

247.4

276.1

28.7

280.1

32.7

5

201.7

220.3

18.6

226.2

24.5

6

230.1

258.6

28.5

264.0

33.9

2000

1

187.3

211.8

24.5

227.7

40.4

2

193.7

224.5

30.8

241.5

47.8

3

192.7

229.0

36.3

243.9

51.2

4

202.0

238.2

36.2

263.0

61.0

5

194.4

220.6

26.6

236.4

42.0

6

195.0

224.3

29.3

245.3

50.3

 

 

Table 3. Summary of necropsy findings.

Dose level (mg/kg bw)

Animal number

Necropsy findings

Control

1

NAD

2

NAD

3

NAD

300

1

NAD

2

(1)

3

NAD

4

NAD

5

NAD

6

NAD

2000

1

NAD

2

NAD

3

NAD

4

NAD

5

NAD

6

NAD

 

NAD: no abnormality detected

(1):

Oesophagus: perforation (ca. 4 mm)

Rectum: faeces not formed

Spleen: moderate congestion hyperaemia

Liver: moderate congestion hyperaemia

Lungs: moderate congestion hyperaemia, different blood distribution, low-grade oedem and emphysema

Heart: high-grade congestion hyperaemia

Kidneys: moderate congestion hyperaemia

Macroscopic suspected diagnosis: oesophagus perforation with food dislocation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
The oral LD50 of the test material in female rats was determined to be >2000 mg/kg bw. One animal given the test material at 300 mg/kg bw showed adverse clinical signs and died on Day 2 post-treatment. Necropsy findings led to the diagnosis "oesophagus perforation with food dislocation" and further to the conclusion that the animal died due to a treatment mistake and not caused by the test material. Except for this incident, there were no test material-related mortalities, clinical signs of systemic toxicity, adverse effects on body weight (gain) or abnormal necropsy findings. Therefore, the material does not fulfil the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not acutely toxic by the oral route.

CLP: not classified
GHS: not classified