Calcium hydrogen phosphonate

Endpoint summary

Description of key information

Acute toxicity potential of calcium hydrogen phosphonate was evaluated by oral route only. The oral LD50 is higher than 2000 mg/kg in rat. No data is available by dermal and inhalation route.

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:

07 January 2016- 30 June 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The key study is considered to be reliable with a klimish score of 1.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute toxicity by oral route :

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.

Justification for classification or non-classification

Based on the available data, the criteria of classification were not filled. According to the Regulation EC n°1272/2008, no classification for acute toxicity is required for calcium hydrogen phosphonate.