Registration Dossier
Registration Dossier
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EC number: 938-980-5 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 May - 06 June 2013
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration
- EC Number:
- 938-980-5
- IUPAC Name:
- Glycine max. (L.) Merr. (Fabacee) aqueous alcoholic ext., concentrate by sequential extractions and filtration
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: Soybean (Glycine max) dry purified extract
Batch No.: 30432/M1
Physical State: powder
Colour: yellow to light brown
Purity: 100%
Storage Conditions: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Species/strain: healthy CBA/CaOlaHsD mice
Source: Harlan Laboratories GmbH, 5800 AN Venray, The Netherlands
Sex: female (nulliparous and non-pregnant)
Age at the beginning of the study: 8-9 weeks
Number of animals:
5 mice / group
3 mice / prescreen test
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Vehicle:
- DMSO
- Concentration / amount:
- 3%, 6.25%, 12.5% w/w
Challengeopen allclose all
- Vehicle:
- DMSO
- Concentration / amount:
- 3%, 6.25%, 12.5% w/w
- No. of animals per dose:
- 20/main test
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 3%, 6.25% and 12.5% (w/v)
- No. of animals per dose:
- 5 mice / group
- Positive control substance(s):
- other: P-Phenylenediamine (CAS 106-50-3)
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- None of the three tested concentrations of the test item reached the stimulation index of 3. The stimulation index at a concentration of 3% was 1.1 The stimulation index at a concentration of 6.25% was 1.0 The stimulation index at a concentration of 12.5% was 1.1
Any other information on results incl. tables
All animals survived throughout the test period without showing any clinical signs.
All animals showed the expected weight development, which includes a weight loss of up to 2 g throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
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