Registration Dossier
Registration Dossier
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EC number: 293-426-3 | CAS number: 91079-38-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 13 march 2013 to 26 march 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study from supporting substance (structural analogue)
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Peptones, casein
- EC Number:
- 293-428-4
- EC Name:
- Peptones, casein
- Cas Number:
- 91079-40-2
- Molecular formula:
- Not applicable
- IUPAC Name:
- Peptones, casein
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
Number of animals per group: 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Age: Pre-test: 10 - 11 weeks (beginning of treatment) / Main study: 8 - 9 weeks (beginning of treatment)
Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water (3/7, v/v)
- Concentration:
- 0; 5; 10 and 25
- No. of animals per dose:
- 4 animals per dose
- Details on study design:
- Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 5, 10, and 25% (w/w) in ethanol/water (3/7, v/v). The application volume, 25 µL/ear/day, was spread over the entire dorsal surface (diameter 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals).
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive control substance: α-Hexylcinnamaldehyde
Vehicle: acetone/olive oil (4/1, v/v)
Test item concentration / DPM measurement / Stimulation Index:
0 / 2446 / 1.0
5 / 3605 / 1.5
10 / 4696 / 1.9
25 / 13736 / 5.7
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1
- Variability:
- 0% conc/2446 DPM
- Test group / Remarks:
- 4 animals
- Remarks on result:
- other: Not sensitising
- Key result
- Parameter:
- SI
- Value:
- ca. 1.5
- Variability:
- 5% conc/3605 DPM
- Test group / Remarks:
- 4 animals
- Remarks on result:
- other: Not sensitising
- Key result
- Parameter:
- SI
- Value:
- ca. 1.9
- Variability:
- 10% conc/4696 DPM
- Test group / Remarks:
- 4 animals
- Remarks on result:
- other: Not sensitising
- Key result
- Parameter:
- SI
- Value:
- ca. 5.7
- Variability:
- 25% conc/13736 DPM
- Test group / Remarks:
- 4 animals
- Remarks on result:
- other: Not sensitising
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Read across data from peptones, casein concluces that test substance would not be a skin sensitizer under the test conditions of this study using OECD 429 and EU Method B.42.
- Executive summary:
Read across data from peptones, casein concluces that test substance would not be a skin sensitizer under the test conditions of this study using OECD 429 and EU Method B.42.
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