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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
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

Test material

1
Chemical structure
Reference substance name:
Benzophenone
EC Number:
204-337-6
EC Name:
Benzophenone
Cas Number:
119-61-9
Molecular formula:
C13H10O
IUPAC Name:
benzophenone

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Results of this test indicated that Benzophenone-3 was not a skin sensitizer.