Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Principles of method if other than guideline:
The principle is base on chemical reactivity of the test item with proteins.
GLP compliance:
yes (incl. QA statement)
Type of study:
direct peptide reactivity assay (DPRA)
Justification for non-LLNA method:
The method used is an in chemico recognized method (OECD442C) that allows to predict sensitizeation potential of a test item.

Test material

Constituent 1
Chemical structure
Reference substance name:
2-benzoylbenzoic acid
EC Number:
201-612-2
EC Name:
2-benzoylbenzoic acid
Cas Number:
85-52-9
Molecular formula:
C14H10O3
IUPAC Name:
2-benzoylbenzoic acid

In chemico test system

Details on the study design:
The interaction between the molecule and lysine or cysteoine rich peptides is detected with HPLC. The depletion rates of lysine and cysteine peptides (after 24 hours of incubation) are used to distinguish the skin sensitizer and non-sensitizer.

Results and discussion

Positive control results:
Yes : cinnamaldehyde 100mM

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
mean
Parameter:
other: depletion of lysine %
Value:
5.07
Positive controls validity:
valid
Key result
Run / experiment:
mean
Parameter:
other: Depletion in cysteine %
Value:
1.32
Positive controls validity:
valid
Other effects / acceptance of results:
All validity criteria are fullfilled wich allows to validate the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The sensitivity is determined according OECD 442C method. The study reports a mean depletion of 5.07% for lysine and 1.32% for cysteine, reflecting no or minimal reactivity and therefore a negative prediction.
Executive summary:

The sensitivity is determined according OECD 442C method. The study reports a mean depletion of 5.07% for lysine and 1.32% for cysteine, reflecting no or minimal reactivity and therefore a negative prediction.