Registration Dossier
Registration Dossier
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EC number: 223-798-4 | CAS number: 4078-19-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-20-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented, scientifically acceptable study report
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Principles of method if other than guideline:
- according to BASF-internal standard
- GLP compliance:
- no
Test material
- Reference substance name:
- β-methylaziridine-1-propiononitrile
- EC Number:
- 223-798-4
- EC Name:
- β-methylaziridine-1-propiononitrile
- Cas Number:
- 4078-19-7
- Molecular formula:
- C6H10N2
- IUPAC Name:
- 3-(aziridin-1-yl)butanenitrile
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Source: Firma Gaukler, Offenbach am Main, Germany
Acclimatization period: at least 8 days before study start
Mean body weight: 2.89 kg
Singly housing in stainless steel wire mesh cages (floor area: 40 x 51 cm).
Room temperature: 20 - 26 °C
Relative humidity: 50 - 80 %
Day/night rhythm: 12 h light and 12 h darkness
The animals were identified via ear tattoo.
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:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 3 minutes and 4 h
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- Clipping of the fur: at least 15 hours before application
Application area: 2.5 x 2.5 cm
Application site: upper third of the back
After application, the test substance was washed off with Lutrol and Lutrol/water (1:1).
Scoring according to Draize, 1959
Readings: 15 - 30 minutes after removal of the test patches and 24 h, 48 h and 8 days after application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: exposure time: 3 min
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: exposure time: 3 min
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48 h
- Score:
- 1.75
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: exposure time: 4 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: exposure time: 4 h
Any other information on results incl. tables
Exposure time |
Scoring time |
Animal |
Erythema score |
Edema score |
3 min |
24 h |
1 |
0 |
0 |
2 |
0 |
0 |
||
48 h |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
8 days |
1 |
0 |
0 |
|
2 |
0 |
0 |
||
4 h |
24 h |
1 |
1 |
0 |
2 |
3 |
3 |
||
48 h |
1 |
1 |
1 |
|
2 |
2 |
2 |
||
8 days |
1 |
0 |
0 |
|
2 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information GHS, UN CAT 3
- Conclusions:
- The skin irritation of the test substance was assesed in rabbits and a slight irritation potential was found.
- Executive summary:
The test substance was applied to shaved skin of rabbits under occlusion for 3 min and 4 h. After 3 min no irritation was detected. After 4 h a mean erythema score of 1.75 (of 4) was observed and an edema of 1.5 (of 4) for 24 - 48 h after exposure. The effects were fully reversible within 8 days.
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