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Description of key information

Acute oral LD 50 > 2000 mg/kg bw

Acute dermal LD 50 > 2000 mg/kg bw

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 key study is GLP-compliant and of high quality (Klimisch 1).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The key study is GLP-compliant and of high quality (Klimisch 1).

Additional information

Oral route:

The oral LD50 in female rats was determined to be > 2000 mg/kg bw for the read-across substance 1-Octadecanol, phosphate, potassium salt in a study conducted according to OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Procedure", December 2001.

For the read-across substance Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts the oral LD 50 in male and female rats was determined to be > 2000 mg/kg bw (nominal corresponding to 723 mg/kg bw a.i.).

Additional data are available for the read-across substance Hexadecyl dihydrogen phosphate. The oral LD50 in male and female rats was determined to be > 4700 mg/kg bw.

 

Inhalation route:

Supporting data are available, for Phosphoric acid, C16-18-alkyl esters, potassium salts.

The LC50 was determined to be > 200 µL/L air. As this value is very low and no higher doses have been tested, no final conclusion on acute inhalation toxicity can be drawn from this data. Therefore the study is considered not relevant for chemical safety assessment.

 

 

Dermal route:

The dermal LD50 in male and female rats for Dihexadecyl phosphate was determined to be > 2000 mg/kg bw in a study conducted comparable to OECD guideline 402.

Justification for read-across:

The main compounds of Phosphoric acid, C16-18-alkyl esters, potassium salts and 1-Octadecanol, phosphate, potassium salt are the mono and di-phosphoric esters.

The typical proportion of mono- to di-ester is 35 % to 50 % for both substances, respectively.

The only difference between the substances is varying chain lengths of the alkyl substituents, C16 and C18 or only C18.

Both substances are surfactants and have a polar “head” (the negatively charged phosphoric acid group) and a relatively inert hydrophobic “tail” (the long alkyl substituents).

The chemical behavior of both alkyl esters is expected to be very similar. The difference chain length of the alkyl substituent (C16 and C18 or only C18) is considered not relevant for the toxicological profile of the substances. This is proven by the close similarity of physico-chemical properties and the similar toxicological profile of the substances. 

In conclusion read-across for toxicological and eco-toxicological endpoints is considered valid without restrictions.

 

 

Justification for selection of acute toxicity – oral endpoint

Data from a study conducted according to OECD guideline 420 (fixed dose procedure) are available for the read-across substance 1-Octadecanol, phosphate, potassium salt. Additional data are available for two read-across substances.

Justification for selection of acute toxicity – dermal endpoint

Data from a study conducted comparable to OECD guideline 402 are available for the read-across substance Dihexadecyl phosphate.

Justification for classification or non-classification

No classification according to CLP; EU GHS (Regulation (EC) No 1272/2008) and directive 67/548/EEC is required for acute toxicity for 1-Octadecanol, phosphate, potassium salt, based on an oral and dermal LD50 of > 2000 mg/kg bw.

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