Registration Dossier
Registration Dossier
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EC number: 214-406-2 | CAS number: 1125-21-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 404 and EEC Directive 92/96, B.4. Study conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- EC Number:
- 214-406-2
- EC Name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- Cas Number:
- 1125-21-9
- Molecular formula:
- C9H12O2
- IUPAC Name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- Reference substance name:
- Oxoisophoron
- IUPAC Name:
- Oxoisophoron
- Reference substance name:
- 2,6,6-trimethyl-2-cyclohexen-1,4-dion
- IUPAC Name:
- 2,6,6-trimethyl-2-cyclohexen-1,4-dion
- Details on test material:
- - name of test substance: Oxoisophoron
- chemical name: 2,6,6-Trimethyl-2-cyclohexene-1,4-dion
- substance number: 96/87
- CAS number: 1125-21-9
- degree of purity/content: 98.87%
- date of manufacturing: 18-may-1995
- physical state/appearance: solid, yellow (at room temperature); liquid, yellowish (at 50 °C)
- storage conditions: room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberch a. d. Riß, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.77 - 3.85 kg
- Housing: single in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland; about 130 g per animal per day.
- Water (e.g. ad libitum): tap water; about 250 mL/day/animal
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- other: Untreated skin of each animal.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the unchanged test substance
- Concentration (if solution): ca. 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal part of the trunk
- %area covered: 2.5 x 2.5 cm
- Type of wrap if used: Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull Stretch (adhesive fleece), Beiersdorf AG.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was performed with Lutrol and Lutrol/Water (1:1)
- Time after start of exposure: 4 h
SCORING SYSTEM:
- Readings after 1; 24; 48; 72 hours and after 8 days.
- Erythema and eschar formation: values 0-4
- Edema formation: values 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 1 - 1 - 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 -0
- Irritation parameter:
- edema score
- Basis:
- other: animal #1, #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen and considering the described findings Oxoisophoron does not give indication of an irritant property to the skin. No classification is needed according to EU Directive 67/548/EEC and Regulation (EC) No. 1272/2008.
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