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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The results of an OECD 422 screening study (Klimisch 1) are considered alongside supporting information relating to the general toxicity and lack of alerts for reproductive toxicity.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The currently available data for reproductive/developmental testing on phosphoric acid include: 1) Negative in vitro mutagenicity genotoxicity evidence (bacterial reverse mutation and in vitro Chromosomal Aberration) suggests a low potential for germ-cell mutagenicity. 2) In an oral gavage study according to OECD 422 guideline (combined Repeated Dose/Reproductive-Developmental Toxicity test), phosphoric acid was administered to rats. No resulting reproductive or developmental effects were identified, nor were overall toxicological effects seen. A No-Observed Adverse Effects Level (NOAEL) for toxicity, reproduction and developmental effects was established at >500 mg/kg-bw/day. 3) An oral gavage study of monosodium phosphate in mice and rats, similar to OECD 414, showed no apparent effects on nidation (i.e., implantation of a fertilised egg in a uterus) or on maternal or fetal survival. There were no significant skeletal or soft tissue abnormalities relative to sham-treated controls.


Short description of key information:
The 54 days NOAEL, following oral exposure (gavage), for reproduction and fertility was > or = 500 mg/kg bw/day in male/female Sprague-Dawley rats. The test was performed according to OECD Guideline 422.

Justification for selection of Effect on fertility via oral route:
No endpoint selected as conclusion based on the assessment of all available data.

Justification for selection of Effect on fertility via inhalation route:
An assessment of the reproductive toxicity via the oral route is made.

Justification for selection of Effect on fertility via dermal route:
An assessment of the reproductive toxicity via the oral route is made.

Effects on developmental toxicity

Description of key information
 The 10 days NOAEL for maternal and developmental toxicity, following oral (gavage) exposure, in male/female CD-1 mouse was > or = 370 mg/kg bw/day and in male/female Wistar rats was > or = 410 mg/kg bw/day. The test was performed according to a method similar to OECD Guideline 414 (with deficiencies).
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
370 mg/kg bw/day
Study duration:
chronic
Species:
mouse
Quality of whole database:
One study investigating the developmental and maternal toxicity of the analogous substance monosodium phosphate is available. Klimsich value for study is 2.
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

The study included as key study under this endpoint was performed on the analogous substance. The justification for read-across is as follows:

In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.

 

The similarities may be based on:

(1)  a common functional group

(2)  the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or

(3)   a constant pattern in the changing of the potency of the properties across the category

 

For orthophosphoric acid read-across from sodium and potassium orthophosphates is considered appropriate for the repeated-dose endpoint based on the following similarities between substances:

 

(1)  All substances are ionic and share the PO43-anion as a common functional groups.

(2)  All members of the group will ultimately dissociate into the common breakdown products of the Na+ or K+ cations (for sodium and potassium orthophosphates respectively) and the PO43-anion (all). Thus phosphoric acid is systemically bioavailable as phosphate. 


Justification for selection of Effect on developmental toxicity: via oral route:
The endpoint record pertaining to the lowest NOAEL is selected. NOAEL is a greater than or equal to value.

Justification for selection of Effect on developmental toxicity: via inhalation route:
A study for developmental toxicity via the oral route is available.

Justification for selection of Effect on developmental toxicity: via dermal route:
A study for developmental toxicity via the oral route is available.

Justification for classification or non-classification

Based on the available data and according to the criteria laid down in the Regulation (EC) No.1272/2008 (EU CLP), phosphoric acid should not be classified for reproductive or developmental toxicity.

Additional information