Disodium phosphonate

Endpoint summary

Description of key information

The LD50 for oral exposure was determined to be 4,000 mg/kg bw.
The LD50 for dermal exposure was determined to be higher than 2,000 mg/kg bw.

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:

04/1995

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Zucht Winkelmann, Paderborn
- Age at study initiation: adult
- Weight at study initiation: 200 g (females), 220 g (males9
- Housing: single cages
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 2 °C
- Humidity (%): 50 - 60 %
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

other: tylose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 - 30 %
- Amount of vehicle (if gavage): 1.0 - 1.7 ml/100 g bw

Doses:

2,000 mg/kg bw
3,000 mg/kg bw
4,000 mg/kg bw
5,000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 24 h, 7 d, 14 d
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

Mortality:

2,000 mg/kg bw (0/6)
3,000 mg/kg bw (0/6)
4,000 mg/kg bw (2/6)
5,000 mg/kg bw (6/6)

Clinical signs:

other: 4,000 mg/kg bw: delayed reactivity

Gross pathology:

no effects related to the substance

Other findings:

- Organ weights: normal
- Histopathology: no findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: other: FDA 1959, OECD 401 (1981)

Conclusions:

The LD50 was deteremined to be 4,000 mg/kg bw; therefore the substance can be considered as practically non-toxic.

Executive summary:

The LD50 was deteremined to be 4,000 mg/kg bw; therefore the substance can be considered as practically non-toxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 000 mg/kg bw

Quality of whole database:

satisfying

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER, France
- Age at study initiation: 6 weeks (males), 8 weeks (females)
- Weight at study initiation: 234 g -246 g (males) and 201 g - 224 g (females)
- Housing: individual cages
- Diet (e.g. ad libitum): freely
- Water (e.g. ad libitum): freely
- Acclimation period: at least 5 days

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

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ml/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

5 males / 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 0, 2, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the test and the observation period.

Clinical signs:

other: No clinical signs were observed during the test and the observation period.

Gross pathology:

No findings in the examined organs and tissues.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test item Disodium phosphonate (BRÜGGOLEN H10) ist higher than 2,000 mg/kg bw by dermal route in the rat.

Executive summary:

The LD50 of the test item Disodium phosphonate (BRÜGGOLEN H10) ist higher than 2,000 mg/kg bw by dermal route in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

satisfying

Additional information

Justification for selection of acute toxicity – oral endpoint
Valid test according to OECD criteria under GLP conditions

Justification for selection of acute toxicity – dermal endpoint
Valid test according to OECD criteria under GLP conditions

Justification for classification or non-classification

With respect to the measured LD50 values in oral and dermal exposure, there is no need for classification into the hazard category "acute toxicity" according to (EU) No. 1272/2008.