Registration Dossier
Registration Dossier
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EC number: 216-630-6 | CAS number: 1631-25-0
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Irritation / corrosion
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Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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 - 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) - 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. - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: house
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Medical Experimental Animals Institute
- Age at study initiation:
- Weight at study initiation: between 2.0 and 2.5 kg
- Housing: stainless steel cage
- Diet (e.g. ad libitum): Oriental RC-4 solid feed
- Water (e.g. ad libitum): yes
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 50 ± 10%.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): artificial lighting for 8 hours a day
IN-LIFE DATES: From: To: - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- 30s
- Observation period (in vivo):
- 1, 24, 48, and 72 hours after instillation
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 30s
SCORING SYSTEM: draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 30 - <= 40
- Max. score:
- 40
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 30 - <= 40
- Max. score:
- 40
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 30 - <= 40
- Max. score:
- 40
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 60
- Max. score:
- 60
- Reversibility:
- other: Examination impossible due to severe chemosis.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 60
- Max. score:
- 60
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Examination impossible due to severe chemosis.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- not fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 81
- Reversibility:
- other: Examination impossible due to severe chemosis.
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 5
- Max. score:
- 5
- Reversibility:
- fully reversible within: 7 daya
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Reversibility:
- other: Examination impossible due to severe chemosis.
- Remarks on result:
- not determinable
- Remarks:
- Examination impossible due to severe chemosis.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The results of this study indicate that the effects on the eyes are not fully reversible in 21 days therefore it has been classified a Eye irritation Cat.2.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The results of this study indicate that the effects on the eyes are not fully reversible in 21 days therefore it has been classified a Eye irritation Cat.2. H319
Based on the results of the study, N-cyclohexylmaleimide is a moderate irritant; Skin irrit cat.2 H315.
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