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EC number: 944-528-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 Feb - 02 Mar 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1992
- Deviations:
- yes
- Remarks:
- several test substance concentrations were applied on one animal
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Jan 1997
- Deviations:
- yes
- Remarks:
- several test substance concentrations were applied on one animal
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4-dimethyl-2H,4H,4aH,5H,9bH-indeno[1,2-d][1,3]dioxine
- EC Number:
- 944-528-8
- Molecular formula:
- C13H16O2
- IUPAC Name:
- 2,4-dimethyl-2H,4H,4aH,5H,9bH-indeno[1,2-d][1,3]dioxine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.8 - 3.0 kg
- Housing: individually in PPO cages
- Diet: Altromin 2123 (Altromin, Lage, Germany), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to ph 2.5, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: for test substance concentrations of 1, 10, 25 and 50% ethanol/diethylphthalat (1:1) was used as vehicle
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentrations: 1, 10, 25, 50 and 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
Reading time points: 1, 24, 48 and 72 hours - Number of animals:
- 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 10 x 10 cm on the back (divided into six fields)
- Type of wrap: The test substance or vehicle was applied to 16-layer gauze patches (2.5 x 2.5 cm) and the patches placed on the appropriate test sites on the back of each rabbit. The gauze patches were secured with adhesive Gothaplast tape (2.5 cm wide) and fixed with Gothaplast tape (5 cm wide) loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: After application the skin sites were cleaned with mild soap and lukewarm water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: test concentration: 100%
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: test concentration: 100%
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: test concentration: 100%
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: test concentration: 100%
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversiblitiy: not applicable
- Remarks on result:
- other: test concentration: 100%
- Irritant / corrosive response data:
- One hour after termination of exposure none of the 4 animals showed skin reactions at any concentration. 24 hours after termination of exposure a very slight erythema (score 1) was observed in all animals at 100%. 48 hours after termination of exposure a very slight erythema (score 1) was observed in one animal at 100%. The other animals were free of any signs of skin irritation after 48 hours at 100%. No skin reactions were observed at 1, 10 and 50% test substance concentration at any reading time point. Only very slight erythema (score 1) was observed in one animal 24 hours after removal of the patch at 25% test substance concentration. The animal was free of signs after 48 hours.
Any other information on results incl. tables
Table 1: Individual skin examination scores with the undiluted test substance
Skin effect |
Erythema |
Edema |
||||||
Scoring |
24h |
48h |
72h |
Meana |
24h |
48h |
72h |
Meana |
Animal 1 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
Animal 2 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
Animal 3 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
Animal 4 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
aMean of 24, 48 and 72 h scores
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this skin irritation study in rabbits the undiluted test substance (100%) was not irritating to the skin. Also the test substance concentrations of 1, 10, 25 and 50% in ethanol/diethylphthalat (1:1) did not show an irritation potential.
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