Registration Dossier
Registration Dossier
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EC number: 262-062-7 | CAS number: 60113-43-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP and non-guideline study, but well documented study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 187, 1973
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,6,6-trimethylbicyclo[3.1.1]heptane-3-carbaldehyde
- EC Number:
- 262-062-7
- EC Name:
- 2,6,6-trimethylbicyclo[3.1.1]heptane-3-carbaldehyde
- Cas Number:
- 60113-43-1
- Molecular formula:
- C11H18O
- IUPAC Name:
- 2,6,6-trimethylbicyclo[3.1.1]heptane-3-carbaldehyde
- Details on test material:
- Name of the test substance used in the study report: Formylpinan R
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- One animal per cage (stainless steel with wire mes walk floors; area 40 x 51 cm); identification via ear tattoo.
They were housed in fully air-conditioned rooms with a temperature in the range of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h dark and 12 h light. The animals were offered a standardized rabbit diet (about 130 g per animal and day) and drinking water (about 250 ml per animal and day).
The acclimatization period was at least 8 days before the beginning of the test (same housing conditions as during the test).
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 15 d
- Number of animals:
- 6
- Details on study design:
- Clipping of the fur: at least 15 h before the beginning of the study
Application area: 2.5 x 2.5 cm (intact and abraded skin)
Application volume: wetting of th test patch (2.5 x 2.5 cm) with the unchaged test substance, and thus about 0.5 ml of the test liquid is absorbed
Application site: upper third of the bck or flanks
Removal of the test substance: not wiped off
Readings: 30 - 60 min after removal of the test patches and 48 h, 72 h, 8 d and 15 d after the beginning of application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 3.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 d
- Remarks on result:
- other: abraded skin
Any other information on results incl. tables
Irritation scores, intact rabbit skin, 24 h exposure, occlusive
|
time |
animal 1 |
animal 2 |
animal 3 |
animal 4 |
animal 5 |
animal 6 |
Erythema |
24 h |
3 |
3 |
3 |
3 |
3 |
3 |
48 h |
3 |
3 |
3 |
2 |
3 |
3 |
|
72 h |
3 |
4 |
3 |
2 |
4 |
3 |
|
Mean 24, 48, 72 h |
3.0 |
3.3 |
3.0 |
2.3 |
3.3 |
3.0 |
|
8 d |
3 |
1 |
2 |
2 |
1 |
3 |
|
15 d |
1 |
0 |
0 |
1 |
1 |
1 |
|
|
|
|
|
|
|
|
|
Edema |
24 h |
2 |
2 |
1 |
2 |
2 |
2 |
48 h |
2 |
2 |
1 |
1 |
1 |
1 |
|
72 h |
2 |
1 |
1 |
1 |
1 |
1 |
|
Mean 24, 48, 72 h |
2.0 |
1.7 |
1.0 |
1.3 |
1.3 |
1.3 |
|
8 d |
1 |
0 |
0 |
0 |
0 |
0 |
|
15 d |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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