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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 January 2016- 30 June 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium hydrogen phosphonate
EC Number:
244-182-1
EC Name:
Calcium hydrogen phosphonate
Cas Number:
21056-98-4
Molecular formula:
Ca.H3O3P
IUPAC Name:
calcium phosphonate
Test material form:
solid: crystalline
Details on test material:
Purity : 95%
Batch number: PCAF151028 Rns
CAS number : 21056-98-4
Chemical name : Phosphonic acid, calcium salt (1:1), Calcium hydrogen phosphonate
Manufacturing date : 28/10/2015
Shelf life or Expiry date : 28/10/2018
Date of analysis : 27/11/2015

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks old at the beginning of the study
- Mean body weight at study initiation: 191.5 g (range: 176 g to 210 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed in threes from the same group in polycarbonate cages with stainless steel lids
- Diet: foodstuff (A04, SAFE) (free access)
- Water: tap water (free access)
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%):30 to 70%
- Air changes (per hr):at least 10 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h/12 h.

IN-LIFE DATES: 19 January 2016 to 03 February 2016.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): the test item was weighed and distilled water was added to a 10 mL volumetric flask. the preparations were stirred by vortex to obtain white solutions just before the administration.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 0; then on days 2, 7 and 14.
- Necropsy of survivors performed: yes (macroscopic).
Statistics:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mL/kg bw
Based on:
test mat.
Remarks on result:
other: no death
Mortality:
No unscheduled deaths occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed during the study.
Body weight:
The body weight evolution of the animals remained normal during the study.
Gross pathology:
The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of calcium hydrogen phosphonatewas higher than 2000 mg/kg in rats.
Executive summary:

The objective of this study was to evaluate the potential acute toxicity of the test item calcium hydrogen phosphonate following a single oral administration (gavage) to rats. This study was conducted in compliance with OECD Guideline No. 423 and the principles of Good Laboratory Practices. The test item was administered once by oral route (gavage) to three fasted female Sprague-Dawley rats at 2000 mg/kg under a dosage-volume of 10 mL/kg in distilled water. Each animal was observed at least once a day for mortality and clinical signs for 14 days. Body weight was recorded on Day 0 and then on Days 2, 7 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.

 No unscheduled deaths occurred during the study and no clinical signs were observed in animals. Body weight was unaffected by the test item treatment. There were no test item-related gross findings.

 Therefore, the oral LD50 of the test item was considered to be higher than 2000 mg/kg in rats and no classification as toxic by oral route according to the criteria of CLP Regulation was required.