4,4'-dihydroxybenzophenone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Precise details of the method used are not given in the text

Principles of method if other than guideline:

The acute dermal toxicity of Benzophenones-3 was tested in albino rabbits. The test substance was applied at various dosages to the epilated
skin of the back or flanks and held in contact for 18-24 hours; it was then washed off. Observations were made daily for signs of toxicity and irritation. Animals
were autopsied following the 5- to 7-day observation period.

GLP compliance:

not specified

Remarks:

Data taken from CIR assessment of benzophenones. Date of testing was prior to requirement for GLP study.

Test type:

standard acute method

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-Hydroxy-4-methoxyphenyl)-phenylmethanone

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test substance was applied at various dosages to the epilated skin of the back or flanks and held in contact for 18-24 hours; it was then washed off.
Observations were made daily for signs of toxicity and irritation. Animals were autopsied following the 5- to 7-day observation period.

Duration of exposure:

18 - 24 hours

Doses:

Various - 2.0 - 16.0 g/kg

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 16 other: g/kg

Based on:

test mat.

Clinical signs:

Local skin reactions, consisting of mild to moderate erythema, were observed in two animals at the 2.0 g/kg dose 24 and 48 hours following the exposure period. No significant pathology was revealed upon autopsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The CIR data review of this benzophenone-3 (assessed to be an acceptable surrogate to 4,4 dihydroxybenzophenone) and many other benzophenone substances used in cosmetics all showed that these substances are non-toxic by dermal exposure. These materials are used as photostabilizers in cosmetics and have a photoprotective
effect on the skin. There is no indication of dermal toxicity and further animal testing on this specific benzophenone is not recommended.