Phosphoric acid, mono and bis-linear butyl esters, potassium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

09 April 1981 to 24 June 2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The approximate lethal dose (ALD) of test material was determined following administration of two dose levels to groups of ten rats by gavage.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

other: lethal dose

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, butyl ester, potassium salt

EC Number:

258-379-5

EC Name:

Phosphoric acid, butyl ester, potassium salt

Cas Number:

53126-06-0

Molecular formula:

KO4P

IUPAC Name:

Potassium butyl hydrogen phosphate

Test material form:

solid - liquid: aqueous solution

Details on test material:

Phosphoric acid, n-butyl ester, potassium salt (1.37 ester groups per molecule)

Specific details on test material used for the study:

- Lot: 124

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- The test material was administered as received to groups of 10 young adult Crl:CD rats in a single dose.
- Surviving rats were weighed and observed during a 14-day recovery period and then sacrificed.

Doses:

18,000 mg/kg bw and 25,000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- The purpose of the study was to determine an LD50 for the test material and use it as a range-finder in determining a safe level for a cholinesterase response study.
- After exhausting the test material, it was decided by the submitter to terminate the LD50 study and an approximate lethal dose (ALD) was determined.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

other: approximate lethal dose

Effect level:

18 000 mg/kg bw

Based on:

test mat.

Mortality:

- Two out of ten animals died in the 18,000 mg/kg dose group
- Eight out of ten animals died in the 25,000 mg/kg dose group
- Deaths occurred within one day after dosing

Clinical signs:

- Wet and stained perineal area
- Stained face
- Diarrhoea
- Weakness
- Salivation in animals receiving 18,000 mg/kg

Body weight:

- Initial weight loss at both dose levels

Gross pathology:

Not investigated

Any other information on results incl. tables

Dose (mg/kg)	Average body weight (g)	Suspension (%)	Average dose (mL)	Density	Mortality ratio
25,000	245	100 (as received)	5.06	1.21	8/10
18,000	243	100 (as received)	3.61		2/10

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The approximate lethal dose was determined to be 18,000 mg/kg and the material was considered to have very low toxicity when administered orally to young adult male Crl:CD rats in single doses.

Executive summary:

The approximate lethal dose (ALD) was investigated by administering 18,000 mg/kg bw and 25,000 mg/kg bw of test material to separate groups of ten male rats by gavage in a single dose under pre-GLP conditions. Mortality was observed within one day of dosing (8/10 animals in the 25,000 mg/kg group and 2/10 animals in the 18,000 mg/kg group). Clinical signs observed were wet and stained perineal area, stained face, diarrhoea and weakness at both dose levels and salivation at 18,000 mg/kg. Initial weight loss was seen at both dose levels. The approximate lethal dose was determined to be 18,000 mg/kg and the material was considered to have very low toxicity when administered orally to young adult male Crl:CD rats in single doses.