Registration Dossier
Registration Dossier
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EC number: 203-825-6 | CAS number: 111-01-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,6,10,15,19,23-hexamethyltetracosane
- EC Number:
- 203-825-6
- EC Name:
- 2,6,10,15,19,23-hexamethyltetracosane
- Cas Number:
- 111-01-3
- Molecular formula:
- C30H62
- IUPAC Name:
- 2,6,10,15,19,23-hexamethyltetracosane
- Test material form:
- other: liquid
- Details on test material:
- synthetic squalane
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:
- no
- Duration of treatment / exposure:
- 4h exposure
- Observation period:
- After removal of wrappings : observation at 30min, 24h, 48h and 72h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.22
- Max. score:
- 0.33
- Reversibility:
- fully reversible
- Remarks:
- no effect after 72h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.33
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.33
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
Any other information on results incl. tables
Detail on results :
Rabbit |
H3711 |
H3712 |
H3713 |
MEAN SCORES |
Sex |
M |
M |
M |
|
Pretest body weight (kg) |
2.6 |
2.6 |
2.8 |
|
Terminal body weight (kg) |
2.7 |
2.7 |
2.8 |
|
Time after patch removal |
Erythema & Eschar formation |
|||
60min |
1 |
1 |
1 |
|
24h |
0 |
0 |
1 |
0.33 |
48h |
0 |
0 |
1 |
0.33 |
72h |
0 |
0 |
0 |
0 |
Time after patch removal |
Edema |
|||
60min |
1 |
0 |
0 |
|
24h |
0 |
0 |
0 |
0 |
48h |
0 |
0 |
0 |
0 |
72h |
0 |
0 |
0 |
0 |
|
|
|
|
|
Sum of mean scores |
|
|
|
0.66 |
Primary Irritation Index (PII) (=Sum of mean scores/3) |
|
|
|
0.22 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to EEC, squalane is not considered irritating to the skin.
- Executive summary:
In vivo irritant or corrosive effects of squalan were determined using EPA OPPTS 870.2500 guideline. The test item was applied on rabbit skin during 4h. The test sites were scored for dermal irritation at 60min after removal of wrappings and scored again at 24, 48 and 72h. The modified Primary Irritating Index is 0.22.
In conclusion, in this study, the squalan is considered non-irritant.
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