Registration Dossier
Registration Dossier
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EC number: 270-485-3 | CAS number: 68442-68-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically reasonable study on the registered substance itself with some deficiencies in documentation. However, given data indicate that the study was well-performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
- Principles of method if other than guideline:
- Test item was applied for 24h to the inner side of the ear of two rabbits, post-observation period was 7 days after washing.
- GLP compliance:
- no
- Remarks:
- study performed prior to GLP implementation
Test material
- Reference substance name:
- Benzenamine, N-phenyl-, styrenated
- EC Number:
- 270-485-3
- EC Name:
- Benzenamine, N-phenyl-, styrenated
- Cas Number:
- 68442-68-2
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- 4-(1-phenylethyl)-N-[4-(1-phenylethyl)phenyl]aniline
- Test material form:
- liquid: viscous
- Details on test material:
- - Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: male/female
- Weight at study initiation: 3-4 kg
- Housing: individually
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl/animal - Duration of treatment / exposure:
- 24h
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: inner side of the ear
- Type of wrap if used: adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and soap / vegetal oil
- Time after start of exposure: 24h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: mean Day 0 and 2 postobservation
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The study was conducted with a scientifically reasonable study design on the registered substance itself with some deficiencies in documentation. However, the given data indicate that the study was well performed. Hence, the results can be considered as sufficiently reliable to assess the irritating potential of the test item towards rabbits. The results indicate that the substance is not irritating to rabbit skin and no classification as skin irritant according to Regulation 1272/2008 is triggered.
- Executive summary:
In a primary dermal irritation study, two New Zealand White rabbits (m/f) were dermally exposed to 500µl of the undiluted test item for 24h hours to the inner side of the ear. Animals then were observed for 7 days.
Maximum score was observed at day 2 post observation (1). In this study, the test item is not a dermal irritant, no classification is needed.
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