Registration Dossier
Registration Dossier
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EC number: 255-485-3 | CAS number: 41669-30-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 - 29 Jan 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study with acceptable restrictions. Lack of detail on test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- lack of detail on test material
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isooctadecyl isooctadecanoate
- EC Number:
- 255-485-3
- EC Name:
- Isooctadecyl isooctadecanoate
- Cas Number:
- 41669-30-1
- Molecular formula:
- C36H72O2
- IUPAC Name:
- 2-methylheptadecyl 3-methylheptadecanoate
- Details on test material:
- - Name of test material (as cited in study report): [only trade name given]
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Des Feuilletas, Campet Lamolere, France
- Age at study initiation: no data
- Weight at study initiation: 2 ± 0.2 kg
- Housing: the animals were housed in individual stainless steel cages (61 x 46 x 34 cm) with a grid floor. The door of each cage was equipped with a feeding device and a 1000 mL drinking bottle.
- Diet: Feed UAR 112, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left flank of the animals were treated with water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 5 days
Reading time points: 1, 24, 48, 72 h, and 5 days - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: the test material was applied on a Codex hydrophilic eight layer gauze (2.5 x 2.5 cm) which was then laid down on the skin. The gauzes were kept in contact with the skin using a hypoallergenic microporous adhesive strip (50 mm wide) and held in place with a stretchable band wraped around the animal.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- other: mean of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 3/3 animals showed a very slight erythema at both 1 h and 24 h reading time points. This was still noticable in 2/3 animals at 48 and 72 h reading time points. 1/3 animals showed a very slight oedema at the 1 h reading time point. However, all signs of irriation were fully reversed by 5 days.
Any other information on results incl. tables
Table 1. Skin irritation scores
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
1 |
1 |
0 |
1 |
0 |
24 h |
1 |
0 |
1 |
0 |
1 |
0 |
48 h |
1 |
0 |
1 |
0 |
0 |
0 |
72 h |
1 |
0 |
1 |
0 |
0 |
0 |
5 days |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value |
1.00 |
0.00 |
1.00 |
0.00 |
0.33 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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