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EC number: 614-657-1 | CAS number: 68609-08-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2007-10-03 to 2007-12-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004/73/EC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1988
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- EC Number:
- 614-657-1
- Cas Number:
- 68609-08-5
- Molecular formula:
- C41H68N4O4
- IUPAC Name:
- Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TETRABBIT Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 2834 - 3389 g
- Housing: Animals were housed individually in metal cages
- Diet: The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum
- Water: The animals received as tap water from self-service water system ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 - 12 air exchange/hour by central air-condition system
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: None
VEHICLE
- Amount(s): None - Duration of treatment / exposure:
- 4 hr
- Observation period:
- Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours, then one week after the patch removal.
- Number of animals:
- 3 Male
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm² of intact skin
- % coverage: Not estimated
- Type of wrap if used: Plastic wrap for 4 hrs
REMOVAL OF TEST SUBSTANCE
- Washing: Water of body temperature
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 9143/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 9135/M
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 9139/M
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 9143/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 9135/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 9139/M
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema in two animals (score 1), well defined erythema (score 2) in one animal. No oedema in all animals. No irritation symptoms /erythema, oedema, and/or other signs)) were observed after 1 week. Study was terminated one week after treatment.
- Other effects:
- no other effects observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was tested for skin irritation in rabbits. The observed symptoms were evaluated as fully reversible alterations.
- Executive summary:
In this skin irritation study albino New Zealand White rabbits were treated with the test item. The test item was applied to the intact skin of rabbits as a single dose of 0.5 g. The irritation symptoms were examined at 1, 24, 48 and 72 hours, then one week after the patch removal.
One hour after the patch removal in two animals very slight erythema (scores 1-1) and in one animal well defined erythema (score 2) was observed on the treated skin surfaces. There was no oedema observed during the study.
24 hours after the patch removal the degree of erythema did not change compared to the previous observation.
48 hours after the patch removal very slight erythema (scores 1-1-1) was found in all animals.
72 hours after the patch removal the irritation symptoms did not change compared to the previous observation.
1 week after the patch removal, no irritation symptoms (erythema, oedema and/or other signs) were observed in any of the animals. Thus, one week after the treatment the study was terminated.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:
- erythema: 1.00, 1.00, 1.33
- oedema: 0.00, 0.00, 0.00
During the study the control areas of all animals were symptom-free. During the study the general state and behaviour of all animals were normal. There were no notable body weight changes during the contact and observation period.
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