Registration Dossier
Registration Dossier
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EC number: 257-170-6 | CAS number: 51388-20-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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-benzyloxyaniline hydrochloride
- EC Number:
- 257-170-6
- EC Name:
- 4-benzyloxyaniline hydrochloride
- Cas Number:
- 51388-20-6
- Molecular formula:
- C13H13NO.ClH
- IUPAC Name:
- 4-benzyloxyaniline hydrochloride
- Test material form:
- solid
1
In vivo test system
Test animals
- Species:
- mouse
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- Test item concentrations of 2.5, 5, and 10% (w/v).
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- concentrations of 2.5% (w/v) in dimethylsulfoxide
- Value:
- 6.91
- Parameter:
- SI
- Remarks:
- concentrations of 5% (w/v) in dimethylsulfoxide
- Value:
- 9.21
- Parameter:
- SI
- Remarks:
- concentrations of 10% (w/v) in dimethylsulfoxide
- Value:
- 8.62
- Test group / Remarks:
- The S.I. for the high dose group was derived from 3 animals only due to the fact that two animals belonging to this group died during the course of the study.
Any other information on results incl. tables
In the groups treated with 2.5 and 5% test item concentration, the animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In the group treated with 10% test item concentration, two animals (animal no. 16 and 20) were found dead on study day 5. Signs of local skin irritation were not observed in any group during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item BOA.HCI 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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