Registration Dossier
Registration Dossier
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EC number: 232-979-7 | CAS number: 9074-98-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Scientific Opinion on the safety and efficacy of Biogalactosidase BL (alphagalactosidase and beta-glucanase) as feed additive for chickens for fattening
- Author:
- EFSA
- Year:
- 2 011
- Bibliographic source:
- EFSA Journal 2011;9(12):2451
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Remarks:
- Not reported in this summary report
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Glucanase, β-
- EC Number:
- 232-979-7
- EC Name:
- Glucanase, β-
- Cas Number:
- 9074-98-0
- Molecular formula:
- not available (see remarks)
- IUPAC Name:
- endo-1,4-ß-glucanase IUBMB EC 3.2.1.4
Constituent 1
- Specific details on test material used for the study:
- - Name as used in the study report: glucanase
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- not specified
- Concentration:
- A dermal application of up to 25 % was used
- No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Results
- Remarks on result:
- other: see below 'Cellular proliferation data / Observations'
- Cellular proliferation data / Observations:
- The stimulation index in the auricular lymph node indicated that the substance is to be classified as a dermal sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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