Registration Dossier
Registration Dossier
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EC number: 209-247-0 | CAS number: 563-41-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 23 May 2018 - 01 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- 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))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
Test material
- Reference substance name:
- Semicarbazide hydrochloride
- EC Number:
- 209-247-0
- EC Name:
- Semicarbazide hydrochloride
- Cas Number:
- 563-41-7
- Molecular formula:
- CH5N3O.ClH
- IUPAC Name:
- semicarbazide hydrochloride
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 55507861
- Expiration date of the lot/batch: 04 January 2020
- Purity: 99.4%
- Appearance: White solid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature (15°C to 25°C) in the dark
Results and discussion
- Positive control results:
- In the case of Cysteine Peptide Depletion: 73.3 %
In the case of Lysine Peptide Depletion: 57.8 %
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Mean of 3 runs
- Parameter:
- other: Cysteine peptide depletion
- Value:
- 1.12 %
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: The mean of 3 runs
- Parameter:
- other: Lysine peptide depletion
- Value:
- 3.43 %
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Solutions of Semicarbazide HCl were successfully analyzed by the validated DPRA analytical method (Envigo analytical method FIA/M101/15) in both Cysteine and Lysine containing synthetic peptides. There was minimal reactivity in both peptides therefore Semicarbazide HCl is placed in the reactivity class of “no or minimal” and hence it is predicted by DPRA to be negative in terms being a potential skin sensitizer.
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