Phosphoric acid, butyl ester

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Sept 1977

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Study design similar to OECD 402; summary report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

performed before GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl acid phosphate

IUPAC Name:

Butyl acid phosphate

Test material form:

liquid: viscous

Details on test material:

slightly viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

weight range between 2 and 3 kg

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

twelve male New Zealand albino rabbits, in a weight range between 2 and 3 kg were used. The animals were immobilized in an animal holder and their backs clipped free of hair with an Cater animal clipper exposing approx. 10% of each animal's skin surface. One-half of the animlas were further prepared by making epidermal abrasions every 2 or 3 cm over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The material was added dermally (5000 mg/kg bw). The animals were observed for mortality at 1, 3, 6, 24, 48, 72 h and daily thereafter for a total of 14 days.

Duration of exposure:

substance was not washed of

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

12/dose

Control animals:

not required

Details on study design:

please refer to "Details on dermal exposure"

Statistics:

none

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

one of 12 rabbits died

Clinical signs:

other: edema, erythema, eschar, necrosis

Gross pathology:

no data

Other findings:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal median lethal dose of the test substance was greater than 5000 mg per kg body weight when rabbits were exposed to Butyl acid phosphate. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.

Executive summary:

The test item was tested for its acute dermal toxicity potential. 12 male rabbits were treated with a dose of 5000 mg/kg bw and observed for 14 days.

The median lethal dose was greater than 5000 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.