Oxybenzone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1953

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was performed prior to OECD guideline availability and GLP but follows basic scientific principles later adopted by OECD.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1953

Report date:

1953

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Oxybenzone

EC Number:

205-031-5

EC Name:

Oxybenzone

Cas Number:

131-57-7

Molecular formula:

C14H12O3

IUPAC Name:

2-benzoyl-5-methoxyphenol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

light yellow powder with no characteristic odor and insoluble in water

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male

Details on test animals or test system and environmental conditions:

Animals were housed individually during study and observation period.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Application to shaved abdominal skin surface of white albino rabbits

Duration of exposure:

18-22 hours, followed by a five day observation period

Doses:

2, 4, 8 and 16 g/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Statistics:

no statistics was applied

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Based on:

test mat.

Mortality:

One death at the 2 g/kg bw level occured and was probably associated with an intercurrent infection and not due to dermal application of the test material. Other than that no mortality occured.

Clinical signs:

other: Only mild skin irritation of short duration developed in 2 animals during the first 2 days of the study and only in animals of the lowest dose level.

Gross pathology:

Following necropsy and autopsy no significant gross findings were noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD 50 (dermal, rabbit): > 16000 mg/kg bw

Executive summary:

In this study for dermal acute toxicity performed with male albino rabbits, no treatment related mortality was observed up to a dose of 16 g/kg bw. Thus the LD50 was set to be greater than 16 g/kg bw.

Only mild skin irritations were noted and only in 2 animals of the low dose group (2 g/kg bw). Also, one animal from this dose group died at day 4 of the observation period. Both observations, mild skin irritation and mortality of one test animal were obviously not treatment related as these occured at the low dose group tested and no skin irritation nor mortality was observed at the higher dose groups.