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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 June 1982 to 09 June 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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:

Test material was applied to the shaved backs of ten rats and the effect was determined via blood cell pathology and plasma cholinesterase.

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

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 109

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

- The backs of 10 male rats were shaved over their backs and collared prior to treatment.
- Animals were approximately equal weight.
- Animals were treated topically with 2 g/kg of test material.
- A second group of rats were not treated and served as controls.
- Twenty four hours after treatment, half of each group of animals were sent to clinical pathology for cholinesterase determinations in red blood cells and plasma.
- Forty eight hours after treatment, the other half of each group of animals were examined in the same manner.
- All rats were sacrificed after the determinations were made.

Duration of exposure:

24 or 48 hours

Doses:

2 g/kg

No. of animals per sex per dose:

10

Control animals:

yes, concurrent no treatment

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

other: effect level

Effect level:

> 2 other: g/kg

Based on:

test mat.

Remarks on result:

other: based on cholinesterase level

Remarks:

no effects in red blood cells or plasma

Mortality:

No unplanned animal deaths were reported

Clinical signs:

No clinical signs were observed

Body weight:

No weight losses were observed

Gross pathology:

Not investigated

Other findings:

No inhibition of cholinesterase activity occurred in the red blood cells or plasma of treated animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Rats treated dermally with 2 g/kg of test material showed no change in cholinesterase activity that could be attributed to the test material and no clinical signs or weight losses were observed.

Executive summary:

Dermal toxicity was investigated in male Crl-CD rats under pre-GLP conditions. Ten male rats of approximately equal weight were selected, the animals were shaved over their backs and collared prior to treatment. Test item (2 g/kg) was applied topically to one group of 10 animals and a second group of 10 animals was not treated and acted as controls. Twenty four hours after treatment, half of each group was sent to clinical pathology for cholinesterase determinations in red blood cells and plasma. Forty eight hours after treatment, the other half of each group was examined in the same manner. All rats were sacrificed after the determinations were made. Rats treated dermally with 2 g/kg of test material showed no change in cholinesterase activity that could be attributed to the test material and no clinical signs or weight losses were observed.