Registration Dossier
Registration Dossier
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EC number: 601-141-6 | CAS number: 111937-03-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 18 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Occlusive exposure, analytical purity of test substance not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive exposure
- GLP compliance:
- no
Test material
- Reference substance name:
- Isononanoic acid, C16-18 (even numbered)-alkyl esters
- EC Number:
- 601-141-6
- Cas Number:
- 111937-03-2
- Molecular formula:
- Unspecified
- IUPAC Name:
- Isononanoic acid, C16-18 (even numbered)-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): isononanoate cetearyle
- Physical state: transparent liquid
- Analytical purity: no data
- Lot/batch No.: 0510 C
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Jègard
- Weight at study initiation: 2.868 kg (mean)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days - Number of animals:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was not washed after the 4-hour exposure period
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Very slight erythema (score 1) was observed in 2/3 rabbits 1 hour after exposure ended, and persisted in 1/3 rabbits up to and including the 72-hour reading time point (see Table 1). 1/3 animals had very slight oedema from the 1-hour reading time point up to and including the 48-hour reading time point. All irritiation effects had cleared completely within 7 days.
- Other effects:
- At the 72-hour reading time point, dry skin was noted at the test site in the rabbit that also showed very slight erythema.
Any other information on results incl. tables
Table 1: Individual skin irritation scores
Observation time |
Rabbit No. |
|||||
|
1 |
2 |
3 |
|||
|
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
0 |
0 |
1 |
1 |
1 |
0 |
24 h |
0 |
0 |
0 |
1 |
1 |
0 |
48 h |
0 |
0 |
0 |
1 |
1 |
0 |
72 h |
0 |
0 |
0 |
0 |
1 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0 |
0 |
0 |
0.66 |
1 |
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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