Registration Dossier
Registration Dossier
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EC number: 252-351-6 | CAS number: 35081-45-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4'-benzyloxy-2-bromopropiophenone
- EC Number:
- 252-351-6
- EC Name:
- 4'-benzyloxy-2-bromopropiophenone
- Cas Number:
- 35081-45-9
- Molecular formula:
- C16H15BrO2
- IUPAC Name:
- 1-[4-(benzyloxy)phenyl]-2-bromopropan-1-one
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Test item concentrations of 10, 25, and 50% (w/v).
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- at concentration of 10% w/v in DMF
- Value:
- 28.21
- Parameter:
- SI
- Remarks:
- at concentration of 25% w/v in DMF
- Value:
- 31.12
- Parameter:
- SI
- Remarks:
- at concentration of 50% w/v in DMF
- Value:
- 32.64
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item TSE-1 was found to be a skin sensitiser under the described conditions. In view of these results, according to the Regulation (EC) No. 1272/2008 on classification, labeling and packaging (CLP) of substances and mixtures, the test item is classified as "skin sensitiser category 1, H317 (“May cause an allergic skin reaction”)". According to the former European Dangerous Substance Directive (Council Directive 67/548/EEC, currently undergoing a phase-out process), the test item is classified as sensitizing and assigned the symbol “Xi”, the indication of danger “Irritant” and the risk phrase R43 ("may cause sensitisation by skin contact”).
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