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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
ecperimental start/end date: 14/03/2018 - 17/03/2018
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:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes
Type of study:
direct peptide binding assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
dark clear liquid

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Parameter:
other: Peptide depletion [%]
Run / experiment:
cysteine peptide
Value:
1.41
Key result
Parameter:
other: Peptide depletion [%]
Run / experiment:
lysyne peptide
Value:
11.32
Other effects / acceptance of results:
It was noticed that analysis of product dissolved in water (without peptide) showed signals at retention time close to cysteine peptide standard. UV spectrum for this peak is different than for cysteine peptide standard. There was no signals for buffer.
UV spectra obtained may suggest that co-elution occurs.
Nevertheless, a series of analyzes has been carried out and the results are presented above. However, the result for cysteine should be regarded as doubtful.
Such situation was not observed for lysine peptide
Also, it should be taken into account that the tested product was not completely dissolved which may affect the final result.

Any other information on results incl. tables

 

 

 

 

18E0447-1PL

Peptide depletion [%]

cysteine peptide

lysyne peptide

1.41

11.32

 

6.    CONCLUSION

 

 

 

18E0447-1PL

Peptide

Reactivity Class

DPRA Prediction

Cysteine

No or minimal reactivity

Negative

Lysyne

Low reactivity

Positive

 

DPRA prediction for the tested product is positive.

Applicant's summary and conclusion

Conclusions:
It was noticed that analysis of product dissolved in water (without peptide) showed signals at retention time close to cysteine peptide standard. UV spectrum for this peak is different than for cysteine peptide standard. There was no signals for buffer.
UV spectra obtained may suggest that co-elution occurs.
Nevertheless, a series of analyzes has been carried out and the results are presented above. However, the result for cysteine should be regarded as doubtful.
Such situation was not observed for lysine peptide
Also, it should be taken into account that the tested product was not completely dissolved which may affect the final result.