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EC number: 603-188-8 | CAS number: 127184-53-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1991-04-15 to 1991-05-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- In contrast to the substance requiring REACH registration, the test substance is in agreement with the polymer definition. The difference is that the substance tested here has a higher content of blocked isophorone diisocyanate (IPDI, CAS RN 4098-71-9) monomer.
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 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 1991 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
Test material
- Reference substance name:
- 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide; 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[(2-oxoazepane-1-carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide
- EC Number:
- 603-188-8
- Cas Number:
- 127184-53-6
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide; 2-oxo-N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[(2-oxoazepane-1-carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[(2-oxoazepane-1-carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)azepane-1-carboxamide
- Test material form:
- other: crystalline solid
- Details on test material:
- Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked, produced by Hüls AG.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley, Pirbright White, BOR:DHPW (SPF)
- Sex: female
- Source: Fa. Winkelmann, Borchen (Germany)
- Age: healthy young adults
- Weight at study initiation: 330 g (mean test); 351 g (mean control)
- Controls: 10 animals; treatment: vehicle
- Housing: max. 5 animals per cage
- Room temperature: 20 +/- 3 °C
- Rel. humidity: 30 - 70 %
- Illumination: 12 h light/dark rythm
- Diet: Ssniff G4 complete diet for guinea pigs
- Water: Drinking water ad libitum
- Acclimatisation: 14 days
- Identification: coulour marks and cage tags
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st application: Induction 25 % occlusive epicutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Induction 25 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1st application: Induction 25 % occlusive epicutaneous
2nd application: Induction 25 % occlusive epicutaneous
3rd application: Induction 25 % occlusive epicutaneous
- No. of animals per dose:
- 10 test animals
10 control animals - Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction: applied quantity approximately 0.5 g of the homogeneous preparation test substance / vehicle
- Induction schedule: 3 identical inductions on days 0, 7, and 14: 6 hour occlusive patch (left side), concentration 25 % assessment of dermal
reactions 6 and 24 hours after administration
- Challenge schedule: day 28 6 hour occlusive patch (right side) assessment of dermal reactions 24, 48, and 72 hours after administration
- Concentrations used for challenge: 25 %
- Positive control: 1-chloro-2,4-dinitrobenzene (not concurrent)
EXAMINATIONS
- Grading system: as usual for skin irritation, 0-8 scores possible
- Pilot study: determination of slightly and not skin irritating concentrations
dermal concentrations: 1; 5; 10; 25 % w/w 4 animals each with 4 different concentrations at different sites
6 hour occlusive patch test
assessment of dermal reactions at patch removal plus 24 and 48 hours after administration - Challenge controls:
- Vehicle alone on one clipped flank
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4-dinitrobenzene (not concurrent)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: None of the applied test substance concentrations caused primary skin irritation.
RESULTS OF TEST
- Sensitization reaction: No signs of skin irritation were observed in the application areas of test and control animals 24, 48, and 72
hours after administration.
- Clinical signs: No treatment related signs of systemic toxicity were observed.
1st, 2nd, and 3rd induction: No signs of skin irritation were observed in the application areas of test and control animals 6 and 24
hours after administration.
- Other: No treatment related effects on body weight development were observed.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this skin sensitisation study according to OECD 406 the test item (51% of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked and 49% of isophorone diisocyanate, caprolactam-blocked) showed no dermal sensitization in female guinea pigs.
- Executive summary:
The skin sensitizing properties of the test item (contains 51% of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, caprolactam-blocked and 49% of isophorone diisocyanate, caprolactam-blocked) were assessed in a buehler test according to OECD 406. Ten female guinea pigs were treated with three identical inductions on days 0, 7, and 14 (occlusive epicutaneous) of 25 % test substance. Ten control animals were similary treated, but with vehicle (petrolatum) alone. Two weeks after the induction treatment all animals were challengend with 25 % substance and the vehicle. All the reactions, especially erythema and oedema formation, were assessed 24, 48 and 72 hours after administration of the challenge treatment.
During the test, neither the test animals nor the controls did show any systemic effects related to the substance or impairment of bodyweight gain due to the substance.
Dermal administration in the three induction phases did not leave to any skin irritation on the administration sites of any of the test and control animals.
Challenge treatment did not cause any signs of dermal irritation in any of the treated animals in the test and control groups.
Therefore, under the conditions of this study the test item showed no dermal sensitization in female guinea pigs.
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