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Registration Dossier
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EC number: 943-447-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Sep - 14 Oct 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study (reversibility of the effects was observed only up to 7 days after removal of the patches)
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)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Board of Health, BronshØj, Denmark
Test material
- Reference substance name:
- Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate
- Molecular formula:
- C14H22O2
- IUPAC Name:
- Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: MØllegaard Breeding and Research Centre A/S, Lille Skensved, Denmark
- Weight at study initiation: 2.3-2.5 kg
- Housing: individually in PPO/HIPS cages (2576 cm²) with perforated floor
- Diet: Altromin 2123, pelleted complete rabbit diet (Chr. Petersen, Ringsted, Denmark), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least 5 days
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: 1:1 (w/w) ethanol/diethylphthalate
- Controls:
- other: adjacent areas of skin treated with vehicle served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 5, 10, 25, 50 and 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 4 females
- Details on study design:
- TEST SITE
- Area of exposure: Appropriate test site on the back (10 cm x 10 cm) divided into two anterior, two centrally and two posterior located test sites. The different test concentrations were applied to the different skin areas simultaneously.
- Type of wrap: The test substance of one of the test concentrations or the vehicle was applied to the skin, using gauze patches of 2.5 cm x 2.5 cm. The patches were secured with 2.5 cm wide adhesive tape and fixed with Scanpor tape (5 cm width). Thereafter Nobifix (6 cm width) was loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance using lukewarm water and mild soap.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #4
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: test concentration: 100%
- Irritation parameter:
- erythema score
- Basis:
- animal: #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: test concentration: 100%
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #4
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: test concentration: 100%
- Irritation parameter:
- edema score
- Basis:
- animal: #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: test concentration: 100%
- Irritant / corrosive response data:
- None to well-defined skin reactions were seen at the test sites with 25, 50 and 100% test substance.
None to slight skin reactions were seen at the test sites with vehicle and with 10% test substance. No skin reactions were seen at the test sites with 5% test substance.
On Day 8 scabs were observed in animal No. 1 at the test sites with 25% and 50% test substance, and in animal No. 2 at the test site with 25% test substance.
On Day 8 few scattered scabs were observed in animal No. 1 at the test site with 10% test substance.
On Day 8 crust was observed in animal No. 1 at the test site with 100% test substance and in animal No. 2, 3 and 4 at the test sites with 50% and 100% test substance.
The skin of the other test fields was intact on Day 8.
Any other information on results incl. tables
Table 1. Results of the skin irritation study.
Rabbit no. |
Test concentration |
Erythema |
Individual mean values (mean after 24/48/72 h) |
Edema |
Individual mean values (mean after 24/48/72 h) |
|||||||
1 h |
24 h |
48 h |
72 h |
1 h |
24 h |
48 h |
72 h |
|||||
1 |
LA |
100% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
RA |
50% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
|
LM |
25% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
|
RM |
10% |
1 |
1 |
1 |
1 |
1.0 |
1 |
1 |
1 |
1 |
1.0 |
|
LP |
5% |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
RP |
V% |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
2 |
LA |
50% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
RA |
25% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
|
LM |
10% |
1 |
1 |
1 |
1 |
1.0 |
1 |
1 |
1 |
1 |
1.0 |
|
RM |
5% |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
LP |
V |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
RP |
100% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
|
3 |
LA |
25% |
1 |
1 |
2 |
2 |
1.7 |
1 |
1 |
1 |
1 |
1.0 |
RA |
10% |
1 |
1 |
0 |
0 |
0.3 |
1 |
1 |
0 |
0 |
0.3 |
|
LM |
5% |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
RM |
V |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
LP |
100% |
2 |
2 |
2 |
3 |
2.3 |
2 |
2 |
2 |
2 |
2.0 |
|
RP |
50% |
1 |
2 |
2 |
3 |
2.3 |
1 |
1 |
2 |
2 |
1.7 |
|
4 |
LA |
10% |
1 |
1 |
0 |
0 |
0.3 |
1 |
1 |
0 |
0 |
0.3 |
RA |
5% |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
LM |
V |
0 |
1 |
1 |
1 |
1.0 |
0 |
0 |
0 |
0 |
0.0 |
|
RM |
100% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
|
LP |
50% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
2 |
2 |
1.7 |
|
RP |
25% |
1 |
2 |
2 |
2 |
2.0 |
1 |
1 |
1 |
1 |
1.0 |
|
LA: Left anterior treatment site
RA: Right anterior treatment site
LM: Left middle treatment site
RM: Right middle treatment site
LP: Left posterior treatment site
RP: Right posterior treatment site
V: Vehicle (1:1 (w/w) ethanol/diethylphthalate)
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this skin irritation study the test substance was irritating to the skin.
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