Registration Dossier

Administrative data

Description of key information

Polyphosphoric acids, esters with triethanolamine, sodium salts was administered in highly purified water as vehicle at dosages of 100, 500, and 1000 mg/kg
body weight/day, and controls received the vehicle only. Polyphosphoric acids, esters with triethanolamine, sodium salts was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.
The NOEL (No Observed Effect Level) for general toxicity in males and females and for reproduction/developmental toxicity was considered to be
1000 mg/kg bw day, the highest dose level used.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Combined repeated dose toxicity study with the Reproduction/Developmental Toxicity Screening Test in the Rat (OECD Guideline 422)

This study is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item (Polyphosphoric acids, esters with triethanolamine, sodium salts) to rats over approximately 28 days. The test item was administered in highly purified water as vehicle at dosages of 100, 500, and 1000 mg/kg body weight/day, and controls received the vehicle only. The test item was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.

 

No evidence of general toxicity in males or females was found up to the highest dose level of 1000 mg/kg bw/day in terms of all of the endpoints examined within this study.

 

All animals survived the scheduled study period. During the in live phase of the study no test item-related effects were noted during daily or detailed weekly clinical observations or functional observational battery tests. Food consumption, body weights and body weight gain were not affected in males or in females at any dose level.

 

Also terminal examinations did not indicate any toxicologically relevant effect. No test item related effects on hematology or clinical biochemistry parameters, no effects on organ weights or findings during necropsy and histopathological examination of males or females were noted at any dose level.

Based on these results, the NOEL (No Observed Effect Level) for general toxicity in males and females was considered to be 1000 mg/kg bw day, the highest dose level used.

Justification for classification or non-classification

The oral administration of Polyphosphoric acids, esters with triethanolamine, sodium salts to rats by gavage, at dose levels of 100, 500 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects. The ‘No Observed Effect Level’ (NOEL) for general toxicity in males and females was considered to be 1000 mg/kg bw/day.

 

Based on the determined NOEL of 1000 mg/kg bw/day and assessment of effects seen in the study, it is considered that the test substance does not meet the criteria for classification for repeat dose toxicity.