Registration Dossier
Registration Dossier
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EC number: 943-554-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3-9 June 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Pre-incubated overnight (guideline recommends 18-24 h)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diethyldimethylcyclohex-2-en-1-one
- EC Number:
- 272-462-3
- EC Name:
- Diethyldimethylcyclohex-2-en-1-one
- Cas Number:
- 68845-36-3
- Molecular formula:
- C12H20O
- IUPAC Name:
- 2,3-diethyl-4,4-dimethylcyclohex-2-en-1-one
- Reference substance name:
- azarbre
- IUPAC Name:
- azarbre
- Test material form:
- other: liquid
- Details on test material:
- Please note that although the substance is stated as the mono-constituent substance diethyldimethylcyclohex-2-en-1-one in the report, analytical data on the same batch shows that the test substance is in fact the multi-constituent substance Reaction mass of 3,5-diethyl-2,5-dimethyl-cyclohex-2-en-1-one and 3,5-diethyl-5,6-dimethylcyclohex-2-en-1-one .
Constituent 1
Constituent 2
Test animals
- Species:
- other: human derived epidermal keratinocytes
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SkinEthic Laboratories, Lyon, France
- Age at study initiation: Not applicable
- Weight at study initiation: Not applicable
- Housing: Not applicable
- Diet (e.g. ad libitum): Not applicable
- Water (e.g. ad libitum): Not applicable
- Acclimation period: Not applicable
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not applicable
- Humidity (%): Not applicable
- Air changes (per hr): Not applicable
- Photoperiod (hrs dark / hrs light): Not applicable
IN-LIFE DATES: From: 3 June 2014 To: 9 June 2014
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 μL (26.3 μL/cm squared)
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 hours post-exposure incubation period
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- Area of exposure: 0.38 cm squared
- % coverage: Not applicable
- Type of wrap if used: Not applicable
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable
SCORING SYSTEM: Not applicable
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: Relative viability (test item)
- Value:
- 7.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. Max. score: 100.0. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density (test item)
- Value:
- 0.078
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative viability (positive control)
- Value:
- 6.2
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. Max. score: 100.0. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density (positive control)
- Value:
- 0.068
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. (migrated information)
- Irritation / corrosion parameter:
- other: other: Relative viability (negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. Max. score: 100.0. (migrated information)
- Irritation / corrosion parameter:
- other: other: Optical density (negative control)
- Value:
- 1.09
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42.25 h. (migrated information)
In vivo
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
Any other information on results incl. tables
| Item | OD of tissues | Mean OD | ± SD of OD | Relative individual tissue viability | Relative mean viability/% | ± SD of Relative mean viability/% |
| Negative control | 1.138 | 1.090 | 0.049 | 104.4 | 100 | 4.5 |
| 1.040 | 95.4 | |||||
| 1.093 | 100.3 | |||||
| Positive control | 0.083 | 0.068 | 0.028 | 7.6 | 6.2 | 2.6 |
| 0.035 | 3.2 | |||||
| 0.085 | 7.8 | |||||
| Test material | 0.060 | 0.078 | 0.031 | 5.5 | 7.2 | 2.9 |
| 0.060 | 5.5 | |||||
| 0.114 | 10.5 |
Mean optical density (OD) values, percentage viabilities and standard deviations (SD) for the negative control, positive control and test material. Mean viabilities are measured relative to the negative control (i.e. this is set at 100%).
The relative mean tissue viability for the positive control was 6.2% compared to the negative control, with a standard deviation of 2.6%. The mean optical density for the negative control was 1.090 and the standard deviation of the percentage viability was 4.5%. The standard deviation of the three test percentage viabilities was 2.9%. The acceptance criteria for negative, positive and test material were therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Category 2 Criteria used for interpretation of results: EU
- Conclusions:
- In a guideline study (OECD TG 439), to GLP, the dermal irritation of azarbre was assessed using the in vitro human epidermis model. The test item was classified as irritant according to EU labelling regulations.
- Executive summary:
In an OECD guideline study (TG 439), conducted according to GLP, the dermal irritation of azarbre was assessed using the in vitro human epidermis model. The quality acceptance criteria were satisfied for both the positive and negative controls and for the test matieral. The relative mean tissue viability of the test item was less than 50% of the negative control (7.2%) and was therefore classified as a category 2 irritant according to EU labelling regulations.
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