4,4'-dihydroxybenzophenone

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Justification for type of information:

Tested on methoxydihydroxybezophenone (benzophenone 3) and cited in European safety review for use in sunscreen.

Data source

Reference

Reference Type:

publication

Title:

Assessment of in vivo genotoxicity of 2-hydroxy-4-methoxybenzophenone

Author:

Robinson S H et al

Year:

1994

Bibliographic source:

Environ. Molecular Mutagen., 23, 312 –317

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

GLP compliance:

not specified

Type of assay:

other: mammalian bone marrow chromosome aberration test (migrated information)

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

Corn oil

Details on exposure:

The test substance was dissolved in corn oil and applied either once in dose levels of 0, 500, 1,670 and 5,000 mg/kg bw/day or for 5 days as a repeated application at dose levels of 0 and 5000 mg/kg bw/day.

Duration of treatment / exposure:

Single treatment and repeat application over 5 days

Frequency of treatment:

Daily

Post exposure period:

Bone marrow collection was at 8 and 12 hours after single application and 12 hours after repeated administration.

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Remarks:

control

Doses / concentrations 2

Dose / conc.:

500 mg/kg bw/day (nominal)

Remarks:

Single dose

Doses / concentrations 3

Dose / conc.:

1 670 mg/kg bw/day (nominal)

Remarks:

Single dose

Doses / concentrations 4

Dose / conc.:

5 000 mg/kg bw/day (nominal)

Remarks:

Single dose

Doses / concentrations 5

Dose / conc.:

5 000 mg/kg bw/day (nominal)

Remarks:

Five day repeated dose

No. of animals per sex per dose:

Five

Control animals:

yes

yes, concurrent vehicle

Positive control(s):

Cyclophospamide was used as a positive control for 5 day treatment at 20 mg/kg/day

Examinations

Tissues and cell types examined:

Bone marrow

Details of tissue and slide preparation:

Bone marrow smears were stained by fluorescence-plus and 50 metaphase spreads from each animal were scored for chromosomal aberrations.
The mitotic index was determined and the percentages of polyploid and endoreduplicated cells were analysed.

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Concludes that no impact on chromosome abberation following in-vivo administration.