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Description of key information

Two acute oral toxicity studies (acute toxic class method) both estimated the LD50 in rats to be >2000 mg/kg bw.
An acute dermal toxicity study (limit test) in the rat estimated the LD50 to be >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute Oral Toxicity:

Two acute oral toxicity studies (Sanders A (2011a) and Manciaux X (2002a)) were conducted according to the acute toxic class method on the substance (Polyphosphoric acids, esters with triethanolamine, sodium salts). Both studies are considered to be of reliability 1 and are summarised below:

 

Sanders A (2011a) - Key Study

Introduction.

The study was performed to assess the acute oral toxicity of the test item following a single oral administration in the Wistar strain rat.

Method.

A group of three fasted females was treated with the test item at a dose level of 359 mg/kg bodyweight (equivalent to 300 mg active ingredient/kg bodyweight). Based on the results from this dose level further groups of fasted females were treated at a

dose level of 2393 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). Dosing was performed sequentially.

The test item was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality.

There were no deaths.

Clinical Observations.

There were no signs of systemic toxicity.

Bodyweight.

All animals showed expected gains in bodyweight over the study period.

Necropsy.

No abnormalities were noted at necropsy.

Conclusion.

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2393 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).

Manciaux X (2002a) - Supporting study

RHODAFAC BP10 was tested for acute oral toxicity in Sprague Dawley rats, according to O.E.C.D. guideline Nb. 423 and EC method B.1 ter, and in compliance with Good Laboratory Practice. Following administration of the test article, a liquid, at a volume of 10 ml/kg, examinations for mortality and abnormal clinical signs were performed during a 14-day study period.

 

First, the test article was administered at 200 mg/kg in water to a group of three fasted males. Animals were observed for 14 days. No mortality occurred and no clinical signs were observed following treatment.

As no mortality had occurred at 200 mg/kg, 3 males were administered the next higher dose of 2000 mg/kg. As no male died, three females were then treated at 2000 mg/kg. No mortality occurred throughout the observation period.

 

No clinical signs were observed in the animals given 200 or 2000 mg/kg.

Body weight gain of the treated animals was similar to that of historical control animals. Macroscopic examination of the main organs revealed no apparent abnormalities.

 

According to the acute toxic class method, as the oral LD50 is considered higher than 2000 mg/kg, no classification is required for RHODAFAC BP10 according to the criteria of Annex VI to Directive 67/548/EEC.

Comments

The substance tested in the Manciaux X (2002a) study had a pH (as a 10% solution) of 2.77. This was a lower pH than the tested substance in the key study (Sanders A (2011a)). It can therefore be considered that although the substance can differ in pH, the pH does not affect the toxicity of the substance.

Acute Dermal Toxicity

An acute dermal toxicity study (limit test) was conducted on the substance and as is summarised below:

Sanders A (2011b)

Introduction.

The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987 and Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008.

Method. 

A group of ten animals (five males and five females) was given a single, 24 hour, semi‑occluded dermal application of the test item to intact skin at a dose level of 2393 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. 

There were no deaths.

Clinical Observations. 

There were no signs of systemic toxicity.

Dermal Irritation. 

There were no signs of dermal irritation.

Bodyweight. 

All animals showed expected gains in bodyweight over the study period.

Necropsy. 

No abnormalities were noted at necropsy.

Conclusion. 

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2393 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).

 

Justification for classification or non-classification

The substance does not meet the criteria for classification for acute toxicity via the oral or dermal routes based on the results of two acute oral toxicity studies and an acute dermal toxicity study, which gave LD50 results of >2000 mg/kg bw in all studies.