Registration Dossier
Registration Dossier
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EC number: 266-030-3 | CAS number: 65996-95-4 Substance obtained by acidulating phosphate rock with phosphoric acid. Normally characterized as containing 40% or more available phosphoric oxide (P2O5). Composed primarily of calcium phosphate.
Endpoint summary
Administrative data
Description of key information
No reliable studies with triple superphosphate are present. Based on reliable studies with diammonium hydrogenorthophosphate for acute oral, dermal and inhalation exposure to rats, the oral and dermal LD50 is >2000 mg/kg bw and the LC50 is > 4.84 mg/L air (analytical). In addition, reliable acute oral, inhalation and dermal toxicity studies with calcium bis(dihydrogenorthophosphate) confirm these findings.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on a common functional group and the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals (refer to the endpoint discussion for further details).
Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 840 mg/m³ air
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on a common functional group and the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals (refer to the endpoint discussion for further details).
Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on a common functional group and the common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals (refer to the endpoint discussion for further details).
Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Additional information
Data on the acute oral, inhalation and dermal toxicity of triple superphosphate are not available. The assessment of acute toxicity was therefore based on studies conducted with reference substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the read-across approach is provided in the technical dossier (see IUCLID Section 13) and within Chapter 5.1 of the CSR.
Oral
No studies for triple superphosphate are present. However, for acute oral toxicity, diammonium hydrogenorthophosphate showed in an OECD 425 guideline study no mortality and no toxicity to rats up to 2000 mg/kg bw. Therefore the LD50 was determined to be >2000 mg/kg bw. In addition, a reliable study with calcium bis(dihydrogenorthophosphate) is available, performed according to the relevant guidelines (EU and US). The acute oral LD50 in male and female rats was estimated to be > 3986 mg/kg bw.
Dermal
No studies for triple superphosphate are present. However, for acute dermal toxicity, diammonium hydrogenorthophosphate showed in an OECD 402 guideline study no mortality and no toxicity to rats up to 5000 mg/kg bw. Therefore the LD50 was determined to be >5000 mg/kg bw. In addition, a reliable study with calcium bis(dihydrogenorthophosphate) is available, performed according to the relevant guidelines (EU and US). The acute dermal LD50 in male and female rats was estimated to be > 2000 mg/kg bw.
Inhalation
No studies for triple superphosphate are present. However, for acute inhalation toxicity, diammonium hydrogenorthophosphate particles showed in an OECD 403, EC B.2 and EPA guideline study no mortality and no toxicity to rats up to 5 mg/L. Therefore, the LC50 was determined to be >4.84 mg/L air (analytical). In addition, a reliable study with calcium bis(dihydrogenorthophosphate) is available, performed according to the relevant guidelines (EU and US). The acute inhalation LC50 in male and female rats was determined to be > 2.6 mg/L.
Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across based on a category approach. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between the source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of acute toxicity – inhalation endpoint
Hazard assessment is conducted by means of read-across based on a category approach. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between the source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across based on a category approach. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between the source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
Based on the data available, triple superphosphate does not have to be classified according to the Directive 67/548/EC and the CLP Regulation for acute oral, dermal and inhalation toxicity.
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