Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts

Endpoint summary

Description of key information

The median lethal dose of Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts after a single oral administration to female rats, observed over a period of 14 days is LD50 cut-off (rat) > 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:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

Name: Phosphoric acid, C14-15 branched and linear alkyl esters, potassium salts
CAS No.: 1893414-79-3
Physical state: white solid at 20 °C
Batch No.: PU61810016
Re-certification date of batch: 09 March 2018
Purity: 100 % (UVCB, lyophilized solid, water content 0.85 % (w/w))
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Housing and Feeding Conditions:
- Full barrier in an air-conditioned room
- Temperature: 22 +- 3 °C
- Relative humidity: 55 +- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Doses:

The starting dose was selected to be 2000 mg/kg body weight.

No. of animals per sex per dose:

3 per step

Control animals:

no

Details on study design:

Observation Period:
All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
Weight Assessment:
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
Clinical Examination:
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology:
At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 2 000 mg/kg bw

Based on:

test mat. (total fraction)

Mortality:

A dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.

Clinical signs:

other: A dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

The test item showed no mortality and no other acute oral toxicity characteristics after a single dose administration.

Clinical Signs - Individual Data

Step	Animal No. / Sex	Starting Dose (mg/kg bw)	Observations / Time
1	1, 2, 3 / Female	2000	nsf during the whole observation period
2	4, 5, 6 / Female	2000	nsf during the whole observation period

bw = body weight;       nsf = no specific findings

Based on these results and according to the acute toxic class method regime no further testing was required.

Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test item is provided.

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose of Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts after a single oral administration to female rats, observed over a period of 14 days is LD50 cut-off (rat) > 2000 mg/kg bw.

Executive summary:

Under the conditions of the presented OECD 423 study, a single oral application of the test item Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The median lethal dose of Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts after a single oral administration to female rats, observed over a period of 14 days is LD50 cut-off (rat) > 2000 mg/kg bw.

According to Annex I of Regulation (EC) 1272/2008 the test item Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts has no obligatory labelling requirement for toxicity and is not classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

reliable without restrictions