Registration Dossier
Registration Dossier
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EC number: 945-453-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen, deaminated
- EC Number:
- 945-453-3
- Molecular formula:
- C7H15N
- IUPAC Name:
- Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen, deaminated
- Test material form:
- liquid
- Details on test material:
- pH value: 12.2
Constituent 1
- Specific details on test material used for the study:
- Batch identification: C520/094/2017
CAS No.: mixture of 7003-32-9 + 6321-23-9
Purity: Cyclohexylamine-methyl: 99.763 area-%
In chemico test system
- Details on the study design:
- Synthetic peptides:
Cysteine- (C-) containing peptide: Ac-RFAACAA-COOH (MW=751.9 g/mol)
Lysine- (K-) containing peptide: Ac-RFAAKAA-COOH (MW=776.2 g/mol)
The peptides are custom material (Supplier: GenScript, Piscataway, NJ, USA and JPT Peptide Technologies GmbH, Berlin, Germany)
Results and discussion
- Positive control results:
- The positive control caused depletion of both peptides comparable to historic data
In vitro / in chemico
Resultsopen allclose all
- Key result
- Parameter:
- other: peptide depletion
- Remarks:
- cystein
- Value:
- -0.12
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Parameter:
- other: peptide depletion
- Remarks:
- lysine
- Value:
- -0.48
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Peptide depletion [%]
cystein |
sample 1 |
sample 2 |
sample 3 |
mean |
SD |
NC: ACN |
- 0.24 |
0.30 |
- 0.06 |
0.00 |
0.28 |
Test substance |
- 0.67 |
- 0.14 |
0.45 |
- 0.12 |
0.56 |
PC: EGDMA in ACN |
60.04 |
63.78 |
64.93 |
62.92 |
2.55 |
lysine |
sample 1 |
sample 2 |
sample 3 |
mean |
SD |
NC: ACN |
- 0.71 |
0.04 |
0.31 |
0.00 |
0.62 |
Test substance |
- 0.33 |
- 0.78 |
- 0.33 |
- 0.48 |
0.26 |
PC: EGDMA in ACN |
9.67 |
10.22 |
10.84 |
10.25 |
0.59 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean C-peptide depletion, caused by the test substance was determined to be -0.12%.
The mean K-peptide depletion, caused by the test substance was determined to be -0.46%. - Executive summary:
Based on the observed results it was concluded that Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen, deaminated shows minimal or no chemical reactivity in the DPRA under the test conditions chosen.
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