Registration Dossier
Registration Dossier
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EC number: 440-870-2 | CAS number: 1013-88-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 440-870-2
- EC Name:
- -
- Cas Number:
- 1013-88-3
- Molecular formula:
- C13 H11 N
- IUPAC Name:
- C,C-Diphenylmethyleneimine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): BPI (Benzophenone imine)
- Analytical purity: 94.8 %
- Lot/batch No.: 11/94 CONTAINER 13
- Physical state: liquid, light yellow
- Storage condition of test material: refrigerator
- Stability under test conditions: proven by reanalysis
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Housing: single housing in stainless steel wire mesh cages with grating, floor area 3000 cm²
- Diet : Kliba-Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, Switzerland), about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 -70
- Photoperiod (hrs dark / hrs light): 12 / 12 (6.00 pm - 6.00 am dark, 6.00 am - 6.00 pm light)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin sites of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied : 0.5 ml unchanged liquid test substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 15 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The test substance has been covered with a test patch (Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece, Baiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: mild detergent (lutrol, lutor/water (1:1))
- Time after start of exposure: 4 hours
SCORING SYSTEM:
ERYTHEMA AND ESCHAR FORMATION VALUE
0: NO ERYTHEMA
1: VERY SLIGHT ERYTHEMA (BARELY PERCEPTIBLE)
2: WELL DEFINED ERYTHEMA
3: MODERATE TO SEVERE ERYTHEMA
4: SEVERE ERYTHEMA (BEET REDNESS) TO ESCHAR FORMATION PREVENTING GRADING OF ERYTHEMA
EDEMA FORMATION VALUE
0: NO EDEMA
1: VERY SLIGHT EDEMA (BARELY PERCEPTIBLE)
2: SLIGHT EDEMA (EDGES OF AREA WELL DEFINED BY DEFINITE RAISING)
3: MODERATE EDEMA (RAISED APPROX. 1 MM)
4: SEVERE EDEMA (RAISED MORE THAN 1 MM AND EXTENDING BEYOND AREA OF EXPOSURE)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 15 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritant / corrosive response data:
- The average score (24 - 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Intensive scaling was observed on day 8 and day 14. No necrosis was observed
Any other information on results incl. tables
Table 1: IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME:
| Reading | Animal | Erythema | Edema |
| 1 hour | 1 | 3 | 3 |
| 2 | 3 | 3 | |
| 3 | 3 | 3 | |
| 24 hours | 1 | 4 | 3 |
| 2 | 4 | 3 | |
| 3 | 4 | 4 | |
| 48 hours | 1 | 4 | 2 |
| 2 | 3 | 1 | |
| 3 | 3 | 2 | |
| 72 hours | 1 | 4 | 2 |
| 2 | 2 | 1 | |
| 3 | 3 | 2 | |
| 8 days | 1 | 3 | 0 |
| 2 | 2 | 1 | |
| 3 | 2 | 1 | |
| 15 days | 1 | 2 | 0 |
| 2 | 2 | 1 | |
| 3 | 2 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.
- Executive summary:
The potential of the test substance to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 mL of the test substance to the intact skin of three white New Zealand rabbits for 4 hours under semi-occlusive dressing. The study was conducted according to OECD TG 404 and GLP. The average score (24 to 72 hours) for irritation was calculated to be 3.4 for erythema and 2.2 for edema. Some findings were not reversible in all animals within 15 days after removal of the patches. Under the test conditions chosen and considering the described findings the test substance gives indication of an severe irritant property to the skin.
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