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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

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Endpoint:
skin sensitisation, other
Type of information:
calculation (if not (Q)SAR)
Remarks:
DEREK prediction
Adequacy of study:
key study
Study period:
07 June 2018 to 15 June 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
no guideline required
Principles of method if other than guideline:
The objective of this study was to obtain a prediction on the potential for skin sensitization of the test item with the in silico model DEREK NEXUS. In this assessment version 6.0.1 of DEREK NEXUS was used.
GLP compliance:
not specified
Specific details on test material used for the study:
- Chemical name: 2-Benzoylbenzoic acid
- CAS Number: 85-52-9
Positive control results:
Not applicable.
Key result
Parameter:
other: Negative
Vehicle controls validity:
not applicable
Negative controls validity:
not applicable
Positive controls validity:
not applicable
Remarks on result:
no indication of skin sensitisation
Other effects / acceptance of results:
DEREK NEXUS version 6.0.1 did not yield any alerts for skin sensitization for the test item. Additionally, the query structure does not contain any unclassified or misclassified features and is consequently predicted to be a non-sensitizer.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the test material has been predicited to be a non-sensitizer.
Executive summary:

A study to investigate the potential for the test item to be a skin sensitizer was conducted in accordance to recognised standards.  An in-vitro software prediction was made using DEREK; the test material has been predicited to be a non-sensitizer.

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
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.
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.
Positive control results:
Yes : cinnamaldehyde 100mM
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.
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.

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
GLP compliance:
yes (incl. QA statement)
Type of study:
activation of keratinocytes
Details on the study design:
The test item was tested at 12 concentrations according to a geometric progression of ratio 2 from 0.98 µM to 2000µM.
Positive control results:
The positive control (cynnamaldehyde) is valid :
- Mean EC1.5 = 11.96
- Mean Imax = 6.13
Key result
Run / experiment:
mean
Parameter:
other: Viability percentage
Value:
70
Positive controls validity:
valid
Key result
Run / experiment:
mean
Parameter:
other: Induction - Imax
Value:
20.1
Positive controls validity:
valid
Key result
Run / experiment:
mean
Parameter:
other: Induction - EC1.5 (µM)
Value:
1 000
Positive controls validity:
valid
Other effects / acceptance of results:
Imax is higher than 1.5
EC1.5 is lower than 1000µM
At the EC1.5 concentration, the viability is higher than 70%
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The skin sensitization was determined according to OECD 442D guideline. The obtained results show that the test item may be classified as potential skin sensitizer.
Executive summary:

The skin sensitization was determined according to OECD 442D guideline. The obtained results show that the test item may be classified as potential skin sensitizer.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

1. A study to investigate the potential for the test item to be a skin sensitizer was conducted in accordance to recognised standards.  An in-vitro software prediction was made using DEREK; the test material has been predicited to be a non-sensitizer.

2. The sensitivity was 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.

3.The skin sensitization was determined according to OECD 442D guideline. The obtained results show that the test item may be classified as potential skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The obtained results show that the test item may be classified as potential skin sensitizer from the OECD 442D guideline.