Registration Dossier

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Administrative data

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 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:

Study does not need to be conducted, as inhalation is no relevant route of exposure.

 

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 read-across approach is appropriate due to similar composition of source substance and registered substance. From the available data it can be concluded that the acute toxicity potential of substances with different alkyl moieties (C16) is comparable.

Data for source substance are conducted on alkyl phosphoric esters, whereas the substance to be registered is neutralized with potassium hydroxide. As both substances dissociates in aqueous media, there are no reasons to assume a different profile for this endpoint.


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 substance to be registered. 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.