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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study is GLP-compliant and has Klimisch score 1.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No effects on reproductive/developmental performance were observed. Therefore, there is no need to carry out further studies in reproductive/developmental toxicity. There is no reason to believe that the negative results would not be relevant to humans.


Short description of key information:
In a combined repeated dose and reproduction / developmental screening test with diammonium phosphate groups of 10 female and 5 male rats were dosed with the test substance in doses of 250, 750 and 1500 mg/kg bw/day. No effects on reproduction/developmental performance were observed. Based on the results the NOAEL for reproduction/developmental toxicity was found to be > 1500 mg/kg bw/day.

Justification for read-across: see above

Justification for selection of Effect on fertility via oral route:
In a 4-week general toxicity and reproductive/developmental toxicity screening test according to OECD guideline 422 the NOAEL for reproductive/developmental toxicity was found to be > 1500 mg/kg bw/day. The study is GLP-compliant and has Klimisch score 1.
Justification for read-across from diammonium phosphate:
Read across from diammonium phosphate to magnesium ammonium phosphate is considered justified based on following background:
Since both the magnesium ammonium phosphate and diammonium phosphate dissociate to their respective ammonium, (magnesium) and phosphate ions, it is considered acceptable to approach the assessment of magnesium ammonium phosphate based on the individual components.
Since Diammonium phosphate is very soluble in water and therefore much more bioavailable (588 g/l; The Merck Index“, 14th Edition, M. J. O’Neil (Editor), Merck Research Laboratories, Division of Merck & Co., Inc., Whitehouse Station, NY, USA (2006)) read across to the only slightly soluble magnesium ammonium phosphate (0.1 g/l) is considered as worst-case assumption. The only difference between the two inorganic salts is the replacement of one ammonia ion and one hydrogen ion by magnesium.
Magnesium from magnesium ammonium phosphate is not assumed to pose an additional risk for acute toxicity since it is an essential mineral and ubiquitous present in food. Therefore an oral NOAEL of 250 mg/kg bodyweight/day for diammonium phosphate is considered as worst-case assumption and can be reliable read-across to magnesium ammonium phosphate.
Given the previous evaluations of magnesium, ammonium and phosphate salts as food additives and as nutrient sources by the EFSA (European Food Safety Authority), SCF (Scientific Committee on Food ) BfR (Federal Institute for Risk Assessment) and JECFA (Joint FAO/WHO Expert Committee on Food Additives) and taking into account that available information on their toxicity did not identify toxicogical effects, any additional testing is unjustified

Effects on developmental toxicity

Description of key information
In a combined repeated dose and reproduction / developmental screening test with diammonium phosphate groups of 10 female and 5 male rats were dosed with the test substance in doses of 250, 750 and 1500 mg/kg bw/day. No effects on reproduction/developmental performance were observed. Based on the results the NOAEL for reproduction/developmental toxicity was found to be > 1500 mg/kg bw/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 500 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study is GLP-compliant and has Klimisch score 1.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No effects on reproductive/developmental performance were observed. Therefore, there is no need to carry out further studies in reproductive/developmental toxicity. There is no reason to believe that the negative results would not be relevant to humans.


Justification for selection of Effect on developmental toxicity: via oral route:
In a 4-week general toxicity and reproductive/developmental toxicity screening test according to OECD guideline 422 the NOAEL for reproductive/developmental toxicity was found to be > 1500 mg/kg bw/day. The study is GLP-compliant and has Klimisch score 1.

Justification for classification or non-classification

Based on the available data, no classification is needed.

Additional information