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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Information published in the Cosmetic Ingreient Review (CIR) assessment of Benzophenones (1983) confirmed that these substances were tested for potential irritation and sensitization to both guinea pig and human skin, and in general, these ingredients were reported to be nonirritating and nonsensitizing at concentrations higher than those found in cosmetics.

RIPT test data included in the CIR report relating to benzophenone-3 (oxybenzone). Four tests involved a total of 600 humans and the test substance was 3% oxybenzone in sunscreen as detailed in this result. In all of those RIPT tests, only one person out of the test population showed any effect that could be considered due to the substance. It was consluded that this substance did not have a sensitising effect on humans.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
according to guideline
Guideline:
other: Kligman Maximization Procedure.
Deviations:
not specified
Principles of method if other than guideline:
A 0.05 ml intradermal injection of 5% Benzophenone-3 in corn oil or 50% Benzophenone-3 in aqueous Freund’s Adjuvant was administered to the shaved back of each of ten female albino guinea pigs per solution.
Seven days following injection, a topical booster patch containing 10% Benzophenone-3 in petrolatum was applied for 48 hours.
Two weeks later, a challenge test of 0.1 ml of 2.5% Benzophenone-3 in petrolatum was applied under an occlusive patch to a virgin site for 24 hours. Sites were scored 24 and 48 hours after patch removal.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from this in-vivo test already existed as having been caried out as part of a cosmetics review in 1983. The data is quite comprehensive and on the basis of the available animal data and clinical human experience, it
is concluded that Benzophenone-1, -3, -4, -5, -9, and -11. are safe for topical application to humans in the present practices of use and concentration in cosmetics. Further non-LLNA testing was not assessed as being necessary
Species:
guinea pig
Strain:
other: Albino
Sex:
female
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
5%,
Day(s)/duration:
7
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
intradermal
Vehicle:
other: freunds adjuvant solution
Concentration / amount:
50%
Day(s)/duration:
7
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No. of animals per dose:
10
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
A 0.05 ml intradermal injection of 5% Benzophenone-3 in corn oil or 50% Benzophenone-3 in aqueous Freund’s Adjuvant was administered to the shaved back of each of ten female albino guinea pigs per solution.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Nothing specified
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
A 0.05 ml intradermal injection of 5% Benzophenone-3 in corn oil or 50% Benzophenone-3 in aqueous Freund’s Adjuvant was administered to the shaved back of each of ten female albino guinea pigs per solution.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Nothing specified
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Results of this test indicated that Benzophenone-3 was not a skin sensitizer.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification