Registration Dossier
Registration Dossier
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EC number: 943-381-7 | CAS number: 2156594-85-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-09-13 - 1994-11-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed and well documented. Guideline study: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- Fatty acids, C18-unsatd., compd. with 2-propanol, 1,1’-iminobis-, N-C12-18-(even numbered) alkyl derivs.
- Cas Number:
- 2156594-85-1
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C18-unsatd., compd. with 2-propanol, 1,1’-iminobis-, N-C12-18-(even numbered) alkyl derivs.
- Test material form:
- gas under pressure: refrigerated liquefied gas
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4h
- Observation period:
- 21 days
- Number of animals:
- 3 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48, 72h
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24,48, 72h
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
Any other information on results incl. tables
Result:
Animal no. |
Effect |
Hour |
Days after application |
Mean score erythema (24/48/72 h) |
Mean score oedema (24/48/72 h) |
|||||
0.5 - 1 |
1 |
2 |
3 |
7 |
14 |
21 |
||||
69 |
Erythema Oedema |
3 0 |
3 2 |
3 1 |
3 1 |
2 1 |
0 0 |
|
3.0 |
1.3 |
113 |
Erythema Oedema |
2 0 |
3 2 |
3 1 |
3 1 |
1 0 |
1 0 |
0 0 |
3.0 |
1.3 |
114 |
Erythema Oedema |
2 0 |
3 2 |
3 1 |
2 0 |
1 0 |
1 0 |
0 0 |
2.7 |
1.0 |
Mean all animals |
|
|
|
|
|
|
|
|
2.9 |
1.2 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registration substance induced reversible irritating effects in rabbits. According to EU criteria, the registration substance should be classified as "irritating".
- Executive summary:
The registration substance was investigated for its skin irritation property according to Guideline OECD 404. Three rabbits were administered semiocclusively by the undiluted registration substance for 4 hours and the skin irritation effects were observed for up to 21 days. Erythema of scores of up to 3 and oedema of scores of up to 2 was observed within the first three days of the observation period. Two animals exhibited on observation day 14 erythema of scores of 1, which were no more present on observation day 21.
The registration substance should be classified as "irritating" according to the EU criteria.
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