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 a 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 on the basis of the physiochemical and toxicological properties of magnesium bis(dihydrogenorthophosphate).

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 19 November 2012 and 20 December 2012.
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 inspection: 10 July 2012, Date of signature: 30 November 2012
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: 8-12 weeks
- Weight at study initiation: The bodyweight variation did not exceed ±20% of the bodyweight of the initially dosed animal.
- Fasting period before study: overnight fast
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum(2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK)
- Acclimation period: at least 5 days

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

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
For the purpose of the study the test item was freshly prepared, as required, as a solution or suspension in distilled water.
The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
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.
Doses:
300 and 2000 mg/kg bw
No. of animals per sex per dose:
300 mg/kg bw: 1
2000 mg/kg bw: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for 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.
- Necropsy of survivors performed: yes
At the end of the observation period the 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.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
The animals showed expected gains in bodyweight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Table 1. 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 periods after doing

(days)

½

1

2

4

1

2

3

4

5

6

7

8

9

10

11

12

13

14

300

1-0

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0 = No signs of systemic toxicity

 

 

Table 2. Individual bodyweight and bodyweight changes– 300 mg/kg bw

 

Dose level mg/kg

Animal

number

and sex

Bodyweight (g) at day

 

Bodyweight gain (g) during week

 

0

7

14

1

2

300

1-0

Female

156

178

191

22

13

 

 

 

Table 3. Individual Necropsy Findings – 300 mg/kg

 

Dose level mg/kg

Animal

number

and sex

Time of death

Macroscopic observations

300

1-0

Female

Killed day 14

No abnormalities detected

 

 

 

Table 4. Individual clinical observations and mortality data.– 2000 mg/kg bw

 

Dose level mg/kg

Animal

number

and sex

Effects noted after dosing (hours)

Effects noted during periods after doing

(days)

½

1

2

4

1

2

3

4

5

6

7

8

9

10

11

12

13

14

2000 

2-0

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-0

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-1

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-2

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3-3

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

  0 = no signs of systemic toxicity

 

 

Table 5. Individual bodyweight and bodyweight changes– 2000 mg/kg bw

 

Dose level mg/kg

Animal

number

and sex

Bodyweight (g) at day

 

Bodyweight gain (g) during week

 

0

7

14

1

2

2000

2-0

Female

146

169

185

23

16

3-0

Female

171

199

222

28

23

3-1

Female

165

185

206

20

21

3-2

Female

160

189

204

29

15

3-3

Female

161

181

202

20

21

 

 

Table 6. Individual Necropsy Findings– 2000 mg/kg

 

Dose level mg/kg

Animal

number

and sex

Time of death

Macroscopic observations

2000

2-0

Female

Killed day 14

No abnormalities detected

3-0

Female

Killed day 14

No abnormalities detected

3-1

Female

Killed day 14

No abnormalities detected

3-2

Female

Killed day 14

No abnormalities detected

3-3

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 item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System − Unclassified).
The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008 (EU CLP), relating to the Classification, Labelling and Packaging of Substances and Mixtures.

This study has been selected as the key study because the study is considered to be adequate and reliable for use as a key study in accordance with Regulation (EC) No. 1907/2006 (REACH). In addition, 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).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study is conducted under the conditions of GLP and in accordance with an appropriate guideline (OECD 420). This study has been assigned a Klimisch reliability of 1.

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:
26th July 2010 - 30 August 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
.
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 2 of the periodic table, calcium or magnesium, and phosphoric acid. Thus, they all share the Ca2+ or Mg2+ cation and the PO43- anion as common functional groups.
2. Both substances will ultimately dissociate into the common breakdown products of the Ca2+ or Mg2+ cations and the PO43- anion.
3. Calcium and magnesium orthophosphates have been shown to have a similar toxicological profile and physicochemical nature and therefore this data is considered to be adequate and reliable for use in read-across. In accordance with the provisions set out in Annex XI, Section 1.5, the results of the studies used for assessment and read-across are adequate for the purpose of classification and labelling and/or risk assessment; have adequate and reliable coverage of the key parameters addressed in the corresponding test method; cover an exposure duration comparable to or longer than the corresponding test method; and adequate and reliable documentation of the applied method is provided in the technical dossier. Orthophosphates are not considered to be genotoxic and are essential micronutrients. As such the acute inhalation toxicty of the target substance will be predominantly determined by the presence of the Mg2+ cation.

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:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Values for relative humidity above the range occasionally occurred, usually following room cleaning, and were considered not to have any influence on the study.
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Deviations:
yes
Remarks:
Values for relative humidity above the range occasionally occurred, usually following room cleaning, and were considered not to have any influence on the study.
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of Inspection: 5th to 9th and 26th to 30th November 2007 Date of signature: 30th April
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:
Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst / Netherlands

- Age at study initiation:
Males: 11 weeks, Females: 11 weeks

- Weight at study initiation:
Males: 300.6 to 318.0 g, Females: 189.6 to 217.6 g

- Fasting period before study:
Not applicable

- Housing:
Animals were housed in groups of 5 of the same sex in Makrolon® type-IV cages with wire mesh tops and standard softwood bedding ("Lignocel" J. Rettenmaier & Söhne GmbH & Co KG, 73494 Rosenberg / Germany, imported by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) including paper enrichment (Enviro-dri from Lillico, Biotechnology, Surrey, UK).

- Diet (e.g. ad libitum):
Animals had ad libitum access to a pelleted standard Harlan Teklad 2914C rat maintenance diet (Provimi Kliba AG, 4303 Kaiseraugst, Switzerland) batch no. 20/10 except during the period when the animals were restrained in exposure tubes. Results of the analyses for contaminants and their limits of acceptability are archived at Harlan Laboratories Ltd.

- Water (e.g. ad libitum):
Community tap water from Füllinsdorf ad libitum in water bottles, except during the period when they were restrained in exposure tubes. Results of representative analyses for contaminants are archived at Harlan Laboratories Ltd.

- Acclimation period:
Performed under Harlan Laboratories Study B68308 for eighteen days under laboratory conditions, after a clinical health examination. Only animals without any visible signs of illness were used for the study. A further observation of clinical signs was performed on the day of exposure, before exposure start.


ENVIRONMENTAL CONDITIONS
Optimal Hygienic Conditions (OHC) inside a barrier system. Air-conditioned with 10 - 15 air changes per hour, continuously monitored environment with a temperature range of 22 ± 3 °C, a relative humidity range of 30 - 70% and a 12 hour fluorescent light / 12 hour dark cycle. Values for relative humidity above the range occasionally occurred, usually following room cleaning, and were considered not to have any influence on the study. These data are not reported but retained at Harlan Laboratories Ltd. A radio program was played during most of the light period.

IN-LIFE DATES: From: Day 1 To: Day 14
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Remarks:
flow-past
Vehicle:
clean air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus:
A CR3020 rotating brush aerosol generator connected to a micronizing jet mill. The aerosol generated was then discharged into the exposure chamber through a 63Ni charge neutralizer.

- Exposure chamber volume:
Not applicable (nose-only, flow-past inhalation exposure chamber)

- Method of holding animals in test chamber:
The animals were confined separately in restraint tubes which were positioned radially around the flow-past, nose-only exposure chamber. Only the nose of each animal was exposed to the test atmosphere.

- Source of air:
Compressed air was supplied by means of an oil free compressor and passed respiratory quality filters before it was introduced into the exposure system.

- Method of conditioning air:
Respiratory quality filters

- System of generating particulates/aerosols:
A dust aerosol was generated from the test item using a CR3020 rotating brush aerosol generator connected to a micronizing jet mill. The aerosol generated was then discharged into the exposure chamber through a 63Ni charge neutralizer.

- Method of particle size determination:
Mercer Impactor (Model 02-130, In-Tox. Products Inc., Albuquerque, New Mexico, U.S.A.).

- Treatment of exhaust air:
Filtered

- Temperature, humidity, pressure in air chamber:
The oxygen concentration, temperature and relative humidity of the test atmosphere were measured continuously during the exposure on test aerosol samples taken at a representative exposure port using a calibrated device. The results were recorded manually and are reported at 30 minute intervals from the start of exposure.

TEST ATMOSPHERE
- Brief description of analytical method used:
Gravimetric determinations of aerosol concentration were performed four times during exposure. The samples were collected on a Millipore®durapore filter, Type HVLP loaded in a 47 mm in-line stainless steel filter sampling device. The filters were weighed before and immediately after sampling using a calibrated balance. The test aerosol concentration was calculated from the amount of test item present on the filter and the sample volume.

- Samples taken from breathing zone:
yes

VEHICLE
No vehicle used.

Analytical verification of test atmosphere concentrations:
no
Remarks:
Gravimetric only
Duration of exposure:
4 h
Concentrations:
Mean Achieved (mg/L) 2.6
The nominal aerosol concentration was 7.5 mg/L air.
Mean Mass Median Aerodynamic Diameter (µm) 3.03, 2.95 and 3.03
Inhalable Fraction (% <4 µm) 59.8% , 61.8 and 59.9%
Geometric Standard Deviation 3.06, 2.97 and 3.04
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration:
14 days

- Frequency of observations and weighing:
All animals were observed for clinical signs at hourly intervals during exposure, immediately on removal from the restraining tubes at the end of exposure, one hour after termination of exposure and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to treatment on the day of exposure (day 1) and on Days 2, 4, 8 and 15 or at death.

- Necropsy of survivors performed:
yes

- Other examinations performed:
None
Statistics:
No statistical analysis was performed as only one group was allocated to the study.
Preliminary study:
Not applicable
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 2.6 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: CL not given
Mortality:
All animals survived the scheduled observation period.
Clinical signs:
other: Slight to moderate ruffled fur was noted in all animals on test day 1, one hour after the end of the exposure and persisted slightly until test day 2 in nine animals. From test day 3 onwards, all animals were free from clinical signs until their scheduled
Body weight:
From test day 1 to test day 2, marginal to slight body weight loss was noted in all animals. Thereafter all animals gained weight until scheduled necropsy.
Gross pathology:
There were no macroscopic findings.
Other findings:
Not applicable.

The nominal aerosol concentration was 7.5 mg/L air.

Interpretation of results:
GHS criteria not met
Conclusions:
The LC50 of Calcium bis(dihydrogenorthophosphate) obtained in this study was estimated to be greater than 2.6 mg/L air (gravimetrically determined mean aerosol concentration). This was the highest technically achievable test concentration. There was no indication of relevant sex-related differences in toxicity of the test item.

In accordance with Regulation (EC) No. 1272/2008 (EU CLP) calcium bis(orthophosphate) is not considered to be classified as acutely toxic via the inhalation route. This study is considered to be acceptable for read across (see justification provided).
Executive summary:

A group of five male and five female albino rats [RccHanTM:WIST(SPF)] was exposed by nose-only, flow-past inhalation for four hours to the test item at agravimetricallydetermined mean concentration of 2.6 mg/L air.All animals were observed for clinical signs and mortality during the inhalation exposure and the subsequent 14-day observation period. Body weights were recorded prior to exposure on test day 1, and during the observation period on test days 2, 4, 8 and 15 before necropsy. On test day 15 all animals were sacrificed and necropsied.

The ranges of aerosol concentration, temperature, relative humidity, oxygen content and airflow rate measured during the exposure were considered to be satisfactory for a study of this type. In addition, the test item was considered to be respirable to rats.

 

All animals survived the scheduled observation period.

 

Slight to moderate ruffled fur was noted in all animals after the end of the exposure and was still present in most animals up to test day 2.Thereafter, all animals were free from clinical signs.

 

Transient body weight loss was noted in all animals from test day 1 to test day 2. Normal body weight development was observed thereafter.

 

No macroscopical findings were present at necropsy.

 

In conclusion, the LC50of Calcium bis(dihydrogenorthophosphate) obtained in this study was estimated to be greater than 2.6 mg/L air (gravimetrically determined mean aerosol concentration). There was no indication of relevant sex-related differences in toxicity of the test item.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study is conducted under the conditions of GLP and in accordance with an appropriate guideline (OECD 403). This study has been assigned a Klimisch reliability of 2. The reliability has been amended in accordance with 'practical guide 6: How to report read-across and categories' which states that the maximum reliability for a read-across study is 2.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20/8/1984 - 7/11/1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
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 containing an alkali metal cation and a phosphate anion.
(2) Both substances will ultimately dissociate into the similar breakdown products of the M2+ cations and the PO43- anion.
(3) In general, independently of the cation under consideration, the water solubility of phosphates decreases with increasing degree of phosphate condensation (orthophosphate > diphosphate > triphosphate > polyphosphate).
In accordance with the provisions set out in Annex XI, Section 1.5, the results of the studies used for assessment and read-across are adequate for the purpose of classification and labelling and/or risk assessment; have adequate and reliable coverage of the key parameters addressed in the corresponding test method; cover an exposure duration comparable to or longer than the corresponding test method; and adequate and reliable documentation of the applied method is provided in the technical dossier. Orthophosphate 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. These studies are supported by a number of acute oral studies on similar compounds which all show magnesium and calcium orthophosphates to possess low systemic toxicity via the oral route (See section 7.2.1.) and therefore comparisons can be drawn to allow read-across for the acute dermal endpoint. Regarding the nature of the substances in question; inorganic, Molecular weight >100, the absorption through the dermal layer will be considerably less than via the gastro-intestinal tract (a route which has shown low systemic toxicity). This approach is considered to be reliable and justified and no further testing for sodium dihydrogenorthophosphate is required.

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:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
details on bodyweight observations during and at the end of the test period were not reported
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressing was used, skin was abraded, exposure duration 72 hours
Principles of method if other than guideline:
Study states protocols were consitent with or exceeded the requirements of EPA and OECD guidelines at the time of the study.
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes
Species:
rabbit
Strain:
other: Stauffland albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California
- Weight at study initiation: 1.642 - 2.146 kg
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: abdominal skin
- % coverage: no data
- Type of wrap if used: gauze binder

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: no
Duration of exposure:
72 hr
Doses:
0, 2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female
Control animals:
other: sham-treated
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: :no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
no data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
A single dermal dose of 2000 mg/kg bw produced no mortalities in a mixed group of albino rabbits (5 male and 5 female).
Clinical signs:
All rabbits in the test group and the sham-exposed control group appeared normal throughout the 14-day test.
Body weight:
No data
Gross pathology:
10 rabbits from the test material exposed group and 4 rabbits from the sham-exposed group were necropsied on day 14 and appeared normal.
Other findings:
- Other observations: local effects: Local dermal effects in the test material group included darkened dose sites, severe erythema, mild edema and the skin at the abrasion marks was separated and filled with reddish fluid and pus-like material. There were no apparent local dermal effects following a 24 hour sham-treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
Calcium bis(dihydrogenorthophosphate) was found to have a dermal LD50 of >2000 mg/kg bw, therefore, calcium bis(dihydrogenorthophosphate) is not considered to be classified according to Regulation (EC) No. 1272/2008 (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).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
No data available

Additional information

Justification for classification or non-classification

Acute oral toxicity: The oral LD50has been determined to be >2000 mg/kg bw and therefore in accordance with Regulation (EC) No. 1272/2008 (EU CLP) magnesium bis(dihydrogenorthophosphate) is not considered to be classified as acutely toxic via the oral route.

Acute inhalation toxicity: The LC50value for the inhalation of the analogous substance calcium bis(dihydrogenorthophosphate) was found to be > 2.6 mg/L (maximum attainable concentration) and therefore, via the use of a read-across approach, magnesium bis(dihydrogenorthophosphate) is not considered to be classified in accordance with Regulation (EC) No. 1272/2008 (EU CLP) and no further testing is recommended.

 

Acute dermal toxicity: Based on considerations of the physicochemical and toxicological properties of magnesium bis(dihydrogenorthophosphate) as discussed in the data waiver submitted under Section 7.2.3 of this dossier, the substance is not considered to be classified as acutely toxic via the dermal route. Further in vivo testing is not scientifically justified.