Registration Dossier
Registration Dossier
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EC number: 288-293-3 | CAS number: 85711-34-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- 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)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ENVIGO, San Pietro al Natisone, Italy
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF at arrival, standard hausing during the study
- Age at study initiation: 12 weeks
- Weight at study initiation: 20.1-21.9 g
- Housing: group housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum) : ad libitum
- Acclimation period: 35 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-25.7
- Humidity (%):27-80
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To: - Vehicle:
- methyl ethyl ketone
- Concentration:
- 5, 2.5, 1, and 0.5%
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: methylethylketone proved to be a suitable solvent
- Irritation: yes (at concentrations >= 5%)
- Systemic toxicity: yes (at concentrations >= 5%)
- Ear thickness measurements: yes
- Erythema scores: yes
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- the stimulation index of 8.8 at 25% hexyl cinnamic aldehyde was in line with historical control data.
- Key result
- Parameter:
- SI
- Value:
- 4.8
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 4.4
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- 1%
- Parameter:
- SI
- Value:
- 3.9
- Test group / Remarks:
- 0.5%
- Cellular proliferation data / Observations:
- see copies of tables on body weights, on DPM and calculated stimulation index attached in background material
- Interpretation of results:
- other: skin sensitising potential
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- see attached information on study design in background material
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg after moistening with 10 µl water
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µl
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µ l
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 87.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 90.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 97.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- see copy of result table attached in background material
Applicant's summary and conclusion
- Interpretation of results:
- other: irritant based on results of pre-tests for LLNA test
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