4,4'-dihydroxybenzophenone

Endpoint summary

Description of key information

Orally non toxic for 2,4-dihydroxybenzophenone and benzophenone-3, which are assessed as an acceptable surrogate substance for 4,4 dihydroxybenzophenone. LD50 values range from 7.7 - 11.6 g/kg in rats.

The CIR data review of 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 oral or dermal toxicity and further animal testing on this specific benzophenone is not recommended.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

No data

Deviations:

not specified

GLP compliance:

not specified

Remarks:

data has been taken from a publication and GLP details were not available

Specific details on test material used for the study:

None

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

8 600 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

Non toxic for 2,4-dihydroxybenzophenone, which is a surrogate substance for 4,4 dihydroxybenzophenone.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

Species:

rabbit

Strain:

other: albino

Sex:

not specified

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed