Registration Dossier
Registration Dossier
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EC number: 213-382-0 | CAS number: 941-69-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: None OECD 404 and non GLP. "Appraisal of Safety of Chemicals in Foods, Drugs, and Cosmetics"(1959) Texas, State Department of Health, Austin
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- N-phenylmaleimide
- EC Number:
- 213-382-0
- EC Name:
- N-phenylmaleimide
- Cas Number:
- 941-69-5
- Molecular formula:
- C10H7NO2
- IUPAC Name:
- 1-phenyl-2,5-dihydro-1H-pyrrole-2,5-dione
- Details on test material:
- Purity:>99.9%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- no dilute 0.5 g
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- Group A: 5min+washed
Group B: 1h+washed
Group C: 24h - Observation period:
- 24h, 48h, 72h, 96h and 5d after dosing
- Number of animals:
- 6
- Details on study design:
- The degrees of erythemia, crusting and edema were recorded
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 5min
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no irritation were observed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no irritations were observed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours dosing
- Score:
- 1.63
- Max. score:
- 2.33
- Remarks on result:
- other: very slight erythema was found in 3 of 6 animals, and slight edema was noted in all animals.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0.39
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 5 days
- Irritant / corrosive response data:
- Irritating Index of Skin Reaction
Days after Dosing
1 day 2 day 3 day 4 day 5 day
Group A: 0 0 0 0 0
Group B: 0 0 0 0 0
Group C: 2.33 2.17 1.67 1.17 0.83 - Other effects:
- no data
Any other information on results incl. tables
Irritation Index
| Groupe | 1 day | 2 day | 3 day | 4 day | 5 day |
A (patched for 5 min and washed) |
0 | 0 | 0 | 0 | 0 |
B (patched for 1 hr and washed) |
0 | 0 | 0 | 0 | 0 |
C (patched for 24 h) |
2.33 | 2.17 | 1.67 | 1.17 | 0.83 |
Group C: very slight erythema was found in 3 of 6 animals, and slight edema was noted in all animals. Thereafter erythemia disappeared almost completely. Edema was gradually improved from the end of the third day, but persisted in 3 animals on the fifth day.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Classification: irritating
- Executive summary:
In a primary dermal irritation study , 6/ males, albino rabbits from The Expeimental Animal Research of Medicine (2.5 - 3.0 kg / 6 animals) were dermally exposed to 0.5 g of PMI (provided by NIPPON SHOKUBAI on 1984.08.20) in undiluted PMI with three patches of 1 inch in diameter. Test sites were covered with a semi-occlusive dresssing for 5 min, 1 hour, 24 hours, respectively. Animals were then observed for 5 days. Irritation was scored by the method of Draize. The was slightly to moderately.
No irritations were observed in the washed groups.
In this study, PMI is classified as slightly to moderately irritating (the category 2 in accordance with GHS) to the skin.
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