Registration Dossier
Registration Dossier
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EC number: 257-765-0 | CAS number: 52234-82-9
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: well-documented, guideline-conform study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)
- EC Number:
- 257-765-0
- EC Name:
- 2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)
- Cas Number:
- 52234-82-9
- Molecular formula:
- C21H35N3O6
- IUPAC Name:
- 6-(aziridin-1-yl)-2-({[3-(aziridin-1-yl)propanoyl]oxy}methyl)-2-ethyl-4-oxohexyl 3-(aziridin-1-yl)propanoate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: WF 4746
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Acclimatization period: at least 8 days before study start
Mean body weight: male 3.18 kg, females 2.92 kg
Singly housing in stainless steel wire mesh cages (floor area 40 x 51 cm).
The animals were identified via ear tattoo.
They were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
The animals were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the animals
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 - 60 min after removal of the test patches and 24 h, 48 h, 72 h after the beginning of the application
- Number of animals:
- 3
- Details on study design:
- Clipping of the fur at least 15 hours before study start.
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks
Removal of the test substance at the end of the application period with Lutrol and Lutrol/water (1:1).
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after beginning of application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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