Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
2005
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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 %,

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.