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EC number: 931-312-3 | CAS number: 53880-05-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-09-27 - 2005-11-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 2004/73/EC, B.4
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers
- EC Number:
- 500-125-5
- EC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers
- Cas Number:
- 53880-05-0
- Molecular formula:
- residual C12H18N2O2, otherwise C36H54N6O6 (trimer) and higher species
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer
- Reference substance name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, isocyanurate type
- EC Number:
- 931-312-3
- Cas Number:
- 53880-05-0
- Molecular formula:
- residual C12H18N2O2, otherwise C36H54N6O6 (trimer) and higher species
- IUPAC Name:
- 3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate homopolymer, isocyanurate type
- Details on test material:
- Test substance: isophorone diisocyanate homopolymer.
Batch no. 49/05,
purity 99.6 %, impurity: isophorone diisocyanate [4098-71-9] 0.39 %,
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: male
- Age: approx. 5-5.5 months at start of >= 20 days adaptation period
- Weight at study initiation: 2.3-2.4 kg
- Controls: untreated skin surrounding the application area
- storage conditions: at room temperature, in tightly closed container
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Concentration: 33.3 %
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
- Number of animals:
- 3 males
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: fine grinding in mortar
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance, approx. 6 cm2
- Vehicle: aqua ad iniectabilia
- Concentration in vehicle: 500 mg test substance / ml vehicle
- Total volume applied: 1500 mg including vehicle = 500 mg test substance
- Occlusion: gauze patch held in place by semi-occlusive non-irritating tape dressing
EXAMINATIONS
- Examination time points: 60 minutes, 24, 48, and 72 hours after patch removal
- Scoring system: Draize (0-4 possible scores each for erythema/eschar and for edema)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 60 min, 24 hrs, 48 hrs, 72 hrs
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- other: none of the three rabbits showed any test item related changes; test substance: IPDI homopolymer, approx. 99.6%
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0
REVERSIBILITY: not applicable - Other effects:
- Under the test conditions none of the three rabbits showed any test substance related changes.
Any other information on results incl. tables
Table: Acute dermal irritation/corrosion test (patch test) of test item in rabbits
0 no pathological findings
E erythema and eschar formations
Oe oedema
| Findings of the skin | Examination schedule | Skin irritation scores animal no. |
||||
1 E/Oe |
2 E/Oe |
3 E/Oe |
||||
500 mg test item/patch/animal |
||||||
| erythema and eschar formations/oedema foramtion | before dosing | 0/0 |
0/0 |
0/0 |
||
| time after removal of the patch (4 -hour exposure) | ||||||
| 60 min | 0/0 | 0/0 | 0/0 |
|||
| 24 hrs | 0/0 |
0/0 |
0/0 |
|||
| 48 hrs | 0/0 |
0/0 |
0/0 |
|||
| 72 hrs | 0/0 |
0/0 |
0/0 |
|||
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions, none of the three rabbits exposed for 4 hours to 500 mg IPDI homopolymer per patch and animal
(semi-occlusive condition) showed any test item-related changes at the examination time-points 60 minutes, 24, 48 and 72 hours after patch
removal. - Executive summary:
The acute skin irritation properties of IPDI homopolymer were estimated according to OECD Guideline 404. A dose of 500 mg test item per animal was applied to the shaved, intact dorsal skin of 3 male rabbits under semi-occlusive conditions. After the 4 -hour exposure period the patch was removed and the resulting reactions were examined. The average scores at 60 min, 24, 48 and 72 hours after patch removal are as follows: erythema/eschar: 0, edema: 0. Therefore, IPDI homopolymer is not irritating to skin.
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