Registration Dossier

Diss Factsheets

Administrative data

Description of key information

The oral LD50 female was determined to be > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Refer to attached document
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 females was determined to be > 2000 mg/kg bw.
Executive summary:

Acute oral toxicty data from 1-Octadecanol, phosphate, potassium salt were used to evaluate the acute oral toxicity for Phosphoric acid, C12-18-alkyl esters, potassium salts.

The acute oral toxicity in rats was determined using the Fixed Dose Procedure as recommended in the OECD Guideline No. 420.

In a sighting study, one female rat was given a single does of 2000 mg/kg bw 1-Octadecanol, phosphate, potassium salt. Slight signs of toxicosis (piloerection) were observed in this rat.

Based on the results from the sighting study, the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment, weight gain was normal and apart from piloerection no other clinical signs were observed. The gross necropsy of the animals revealed no pathological abnormalities.

The oral LD50 females was determined to be > 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Read-across from a study according to OECD 401 Guideline with GLP

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

Acute oral toxicty data from 1-Octadecanol, phosphate, potassium salt were used to evaluate the acute oral toxicity for Phosphoric acid, C12-18-alkyl esters, potassium salts.

The acute oral toxicity in rats was determined using the Fixed Dose Procedure as recommended in the OECD Guideline No. 420.

In a sighting study, one female rat was given a single doses of 2000 mg/kg bw 1-Octadecanol, phosphate, potassium salt. Slight signs of toxicosis (piloerection) were observed in this rat.

Based on the results from the sighting study, the main study was carried out with four more female animals each given a dose of 2000 mg/kg b.w. All animals in the main study survived the treatment, weight gain was normal and apart from piloerection no other clinical signs were observed. The gross necropsy of the animals revealed no pathological abnormalities.

The oral LD50 female was determined to be > 2000 mg/kg bw.

 

Acute inhalation toxicity

Testing on vertebrate animals for the purpose of REACH shall be undertaken only as a last resort.

Information from acute oral toxicity are available, a LD50 value of > 2000 mg/kg was established and no signs of toxicity were observed, thus the acute intrinsic toxicity is considered to be low.

Data from in-vitro skin and eye irritation studies indicate irritating properties of the substance.

Furthermore supporting information from a similar substance Phosphoric acid, C16-18-alkyl esters, potassium salts is available, supporting the low intrinsic toxicity. However, the tested limit dose is below the limit dose required by the guideline, therefore the study is considered not relevant for chemical safety assessment.

 

Considering the physico-chemical properties of the substance exposure of humans via inhalation is not likely. The vapour pressure of Phosphoric acid, C12-18-alkyl esters, potassium salts is very low (1.5E-6 Pa) and the substance is marketed as aqueous suspension. Furthermore, no industrial spraying, or generating of aerosols is expected during processing. Therefore no high peak exposure after inhalation exposure is expected. As a precautionary measure a DNEL for short term exposure after inhalation will be set based on long-term inhalation DNEL.

 

In conclusion, further testing on vertebrate animals for acute toxicity via inhalation route is scientifically not necessary, taken into account available information reflecting low acute intrinsic toxicity. As well exposure of humans via inhalation is not likely, taken into account physico-chemical properties and use description of the substance.

Acute dermal toxicity

The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity of STOT SE by the oral route. The LD50 is > 2000 mg/kg bw.

Justification for classification or non-classification

Based on relevant, reliable and adequate data,Phosphoric acid, C12-18-alkyl esters, potassium salts does not have to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to acute toxicity.