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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
other: in chemico
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: In-house validated in vitro study, reported as summary, non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Direct peptide binding assay (DPRA) performed as described in Bauch C. et al. (2011), Toxicology in Vitro 25, 1162 – 1168.
Principles of method if other than guideline:
Binding to Cysteine and Lysine containing model peptides in chemico
GLP compliance:
no
Type of study:
other: Direct peptide binding assay

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): 2-(2-Methylallyl)-cyclododecanon-Rein
- Physical state: Liquid/ colorless, clear
- Analytical purity: 99.3 area-% (not corrected with the water content), Capillary GC-analysis
- Lot/batch No.: 2-(2-Meth-allyl)cyclododecanon (MACD Probe aus B410.16 vom 04.10.2012)
- Storage condition of test material: Room temperature

In vivo test system

Test animals

Species:
other: not applicable
Strain:
other: not applicable
Details on test animals and environmental conditions:
not applicable

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: not applicable
Vehicle:
other: not applicable
Concentration / amount:
Test substance was solved at a 100 mM concentration in acetonitrile.
Test substance were incubated with each peptide in ratios of 1:10 (for C-peptide) or 1:50 (for K-peptide).
Challengeopen allclose all
Route:
other: not applicable
Vehicle:
other: not applicable
Concentration / amount:
Test substance was solved at a 100 mM concentration in acetonitrile.
Test substance were incubated with each peptide in ratios of 1:10 (for C-peptide) or 1:50 (for K-peptide).
No. of animals per dose:
not applicable
Details on study design:
not applicable
Challenge controls:
not applicable
Positive control substance(s):
yes
Remarks:
EGDMA

Results and discussion

Positive control results:
The mean Cysteine-peptide depletion, caused by the PC was determined to be 50.7 %.
The mean Lysine-peptide depletion, caused by the PC was determined to be 13.94%.

Any other information on results incl. tables

The mean Cysteine-peptide depletion, caused by the test substance was determined to be 5.61%.

The mean Lysine-peptide depletion, caused by the test substance was determined to be -3.21 %.

No co-elution of test substance and peptides was noticed.

The samples of the test substance with the peptides were emulsions directly after application and after the 24-hour incubation time. Thus

the samples were centrifuged prior to HPLC analysis.

Applicant's summary and conclusion

Interpretation of results:
other: Non peptide binding
Conclusions:
In a weight of evidence, all present in vitro data on dermal sensitization do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.