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EC number: 915-610-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 May - 18 June 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No data on analytical purity of test substance given; extended to investigate 5 different concentrations of the test substance and a vehicle control on each animal
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- No data on analytical purity of test substance given; extended to investigate 5 different concentrations of the test substance and a vehicle control on each animal
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Danish National Testing Board, Denmark
Test material
- Reference substance name:
- Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- EC Number:
- 915-610-0
- Molecular formula:
- C13H2O
- IUPAC Name:
- Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.7 - 2.2 kg
- Housing: individually in sigle polypropylene cages (45x 55 cm) with perforated floor
- Diet: pelleted Altromin 2123 diet, ad libitum
- Water: ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 6
- 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, 5, 10, 25% (w/w) and 100%
VEHICLE
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 21 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 10 x 10 cm on the dorsal area of the trunk divided into 6 test sites with a 1 cm wide adhesive tape: two anterior located test sites, two centrally located test sites and two posterior located test sites
- Type of wrap if used: The test substance or vehicle was applied to 6 gauze patches (2.5 x 2.5 cm) each and the patches were placed on the appropriate test sites on the back of each rabbit. The gauze patches were secured with a cross of 1 cm wide adhesive tape and fixed with Scanpor tape, 7.5 cm width, loosely wound rund the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: Treated skin was cleaned with soap and lukewarm water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
4.5, 24, 48 and 72 h after exposure and on Day 7, 14 and 21
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #4
- Remarks:
- 100% test substance
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks:
- A dense layer of white scales was observed in all animals on Day 14; animal #1 and #4: scattered white scales with intact skin underneath on Day 21, indicating reversibility of effects; animal #2: no skin reaction on Day 21
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 100% test substance
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks:
- A dense layer of white scales was observed in all animals on Day 14; scattered white scales with intact skin underneath on Day 21, indicating reversibility of effects
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 100% test substance
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal: #2 and #3
- Remarks:
- 100% test substance
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- 100% test substance
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- On day 7: A layer of scales was observed at the test sites in two rabbits treated with a 100% concentration (#1 and #2) and crusts were observed at the test sites in two rabbits treated with a 100% concentration (#3 and #4). A layer of scales was observed in all the rabbits at the test sites treated with a 25% concentration.
On day 14: A dense layer of white scales was observed at the test sites treated with a 100% concentration in all the rabbits. In rabbits #3 and #4 scattered white scales were observed at the test sites treated with a 25% concentration.
On day 21: Scattered white scales with intact skin underneath were observed at the test sites treated with a 100% concentration in three rabbits (#1, #3 and #4), in rabbit #2 no reaction on the skin was observed.
Any other information on results incl. tables
Table 1. Results of skin irritation study
Rabbit No |
Location of test side |
Test substance concentrations |
Erythema-Eschar observed at hours |
Edema observed at hours |
||||||||
4.5 |
24 |
48 |
72 |
Mean 24/48/72 h |
4.5 |
24 |
48 |
72 |
Mean 24/48/72 h |
|||
#1 |
A.L. |
100% |
0 |
2 |
3 |
3 |
2.67 |
1 |
2 |
3 |
3 |
2.67 |
|
A.R. |
25% |
0 |
2 |
2 |
2 |
2.00 |
1 |
2 |
2 |
2 |
2.00 |
|
M.L. |
10% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
M.R. |
5% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
P.L. |
1% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
P.R. |
V |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
#2 |
A.L. |
V |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
A.R. |
5% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
M.L. |
25% |
0 |
2 |
2 |
2 |
2.00 |
0 |
1 |
1 |
1 |
1.00 |
|
M.R. |
1% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
P.L. |
10% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
P.R. |
100% |
0 |
2 |
3 |
3 |
2.67 |
0 |
1 |
2 |
2 |
1.67 |
#3 |
A.L. |
V |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
A.R. |
10% |
0 |
1 |
1 |
1 |
1.00 |
0 |
1 |
1 |
0 |
0.67 |
|
M.L. |
100% |
1 |
3 |
3 |
3 |
3.00 |
1 |
1 |
2 |
2 |
1.67 |
|
M.R. |
25% |
1 |
2 |
2 |
2 |
2.00 |
1 |
2 |
2 |
2 |
2.00 |
|
P.L. |
5% |
0 |
0 |
0 |
1 |
0.33 |
0 |
0 |
0 |
0 |
0.00 |
|
P.R. |
1% |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0.00 |
#4 |
A.L. |
100% |
0 |
2 |
3 |
3 |
2.67 |
0 |
1 |
3 |
3 |
2.33 |
|
A.R. |
5% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
M.L. |
1% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
M.R. |
25% |
0 |
2 |
2 |
2 |
2.00 |
0 |
1 |
1 |
1 |
1.00 |
|
P.L. |
10% |
0 |
0 |
0 |
0 |
0.00 |
0 |
0 |
0 |
0 |
0.00 |
|
P.R. |
V |
0 |
0 |
1 |
1 |
0.67 |
0 |
0 |
0 |
0 |
0.00 |
A.L.: anterior left treatment site
P.L.: posterior left treatment site
A.R.: anterior right treatment site
P.R.: posterior right treatment site
M.L.: mid-left treatment site
M.R.: mid-right treatment site
V: vehicle (ethanol/diethylphthalat (1:1))
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Irrit. 2 according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this skin irritation study in rabbits the undiluted test substance (100%) and a concentration of 25% in ethanol/diethylphthalat (1:1) was irritating to the skin.
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