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EC number: 216-630-6 | CAS number: 1631-25-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1985 (published)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Guideline standards not referenced within study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Six healthy male white house rabbits (2.5 - 3.0 kg weight) were used per each of 3 test groups.
Group A: Closed application area of the sample-containing patch washed with 20 mL of purified water after 5 minutes of patch application.
Group B: Closed application area of the sample-containing patch washed with 20 mL of purified water after 1 hour of patch application.
Group C: Sample-containing patch applied for 24 hours.
Hair in the flank of each animal was shaved short, 0.5 g of the sample was spread on an adhesive tape for patch test having a diameter of 1.0 inch, and this tape was affixed to 3 points of the shaved area in a closed state. After 24 hours of skin application of the sample-containing patch to the animals in Group A through C (the adhesive tape of Group C was removed), the skin area was observed for symptoms. Follow-up observation was continued for 5 days. Erythema and crust formation and edema observed with the eye were evaluated using Draize criteria. Primary irritation after 24 hours of sample application was also evaluated. - GLP compliance:
- not specified
Test material
- Reference substance name:
- 1-cyclohexyl-1H-pyrrole-2,5-dione
- EC Number:
- 216-630-6
- EC Name:
- 1-cyclohexyl-1H-pyrrole-2,5-dione
- Cas Number:
- 1631-25-0
- Molecular formula:
- C10H13NO2
- IUPAC Name:
- 1-cyclohexyl-2,5-dihydro-1H-pyrrole-2,5-dione
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Source: The Sponsor (Nippon Shokubai). Lot/batch No.: Not specified
- Expiration date of the lot/batch: Not specified
- Purity test date: Not specified
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: n/a
- Specific activity: n/a
- Locations of the label: n/a
- Expiration date of radiochemical substance: n/a
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Not specified
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: Not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Not specified
- Preliminary purification step (if any): Not specified
- Final dilution of a dissolved solid, stock liquid or gel: Not specified
- Final preparation of a solid: Not specified
FORM AS APPLIED IN THE TEST (if different from that of starting material) Not specified
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) n/a
OTHER SPECIFICS: n/a
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- White house rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Medical Experimental Animals Institute
- Age at study initiation: Not specified
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: One animal each was housed in stainless steel cage for house rabbits and kept in an animal room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22ºC +/- 3ºC
- Humidity (%): 50% +/- 10%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 16 hrs dark, 8 hrs light
IN-LIFE DATES: From: To: Not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- Hair on the flank (test area) of each animal was shaved short
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): n/a
VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): n/a
- Concentration (if solution): n/a
POSITIVE CONTROL
- Amount(s) applied (volume or weight): n/a
- Concentration (if solution): n/a - Duration of treatment / exposure:
- 24 hour exposure period
- Observation period:
- 5 days obervation period
- Number of animals:
- 6 per group, 3 groups in total
- Details on study design:
- TEST SITE
- Area of exposure: 1.0 inch (2.5 cm)
- % coverage: Not specified
- Type of wrap if used: Not specified
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 20 mL of distilled water on Group A and Group B
- Time after start of exposure: 5 minutes for Group A, 1 hour for Group B
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 hours after application, with follow-up observation continued for 5 days
SCORING SYSTEM:
- Method of calculation: Erythema and crust formation and edema observed with the eye were evaluated using Draize criteria. Primary irritation after 24 hours of sample application was also evaluated using the irritation index below.
Irritation index = (total erythema points + total edema points) / 6 (animals)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- Group C
- Time point:
- other: 5 d
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- Group C
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 5 days
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Group A - Mild erythema was seen after 24 hours and throughout the 5-day observation period in 5 out of 6 animals. No edema was observed.
Group B - Mild erythema was seen after 24 hours in 5 out of 6 animals. Erythema showed signs of relief from Day 2 or 3. Mild edema was also seen in 3 animals but was resolved on Day 2.
Group C - After 24 hours, moderate erythema was seen in all animals. Little relief of the symptom was seen for the 5-day observation period. Mild or moderate edema also occurred. Slight relief was subsequently observed, but edema was still seen in all animals on Day 5.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Based on the results of the study, N-cyclohexyl maleimide is a moderate irritant.
- Executive summary:
A Primary Skin Irritation Test in House Rabbits was undertaken on 6 rabbits in each of three groups (A-C). Hair in the flank of each animal was shaved short, 0.5 g of the sample was spread on an adhesive tape for patch test having a diameter of 1.0 inch, and this tape was affixed to 3 points of the shaved area in a closed state.
Group A - Mild erythema was seen after 24 hours and throughout the 5-day observation period in 5 out of 6 animals. No edema was observed.
Group B - Mild erythema was seen after 24 hours in 5 out of 6 animals. Erythema showed signs of relief from Day 2 or 3. Mild edema was also seen in 3 animals but was resolved on Day 2.
Group C - After 24 hours, moderate erythema was seen in all animals. Little relief of the symptom was seen for the 5-day observation period. Mild or moderate edema also occurred. Slight relief was subsequently observed, but edema was still seen in all animals on Day 5.
Based on the results of the study, N-cyclohexyl maleimide is a moderate irritant. If on skin, washing the skin immediately with abundant running water should reduce irritation to some extent.
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