Registration Dossier
Registration Dossier
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EC number: 294-620-0 | CAS number: 91744-56-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Feb - 07 Feb 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Lack of study details, occlusive exposure.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of study details, occlusive exposure
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerides, mixed C8-10 and succinyl
- EC Number:
- 294-620-0
- EC Name:
- Glycerides, mixed C8-10 and succinyl
- Cas Number:
- 91744-56-8
- Molecular formula:
- Not applicable: Complex UVCB substance
- IUPAC Name:
- Glycerides, mixed C8-10 (even numbered) and succinyl
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: transparent liquid
- Analytical purity: no data
- Other: Density: 0.98 g/mL
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.044 kg (mean)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Type of wrap if used: the treated skin was covered with a patch and held in place with an occlusive dressing.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- /Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- /Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- /Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- /Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- /Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- /Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- reversibility: not applicable
- Irritant / corrosive response data:
- No local irritating effects were observed during the study period.
- Other effects:
- No further local or systemic effects were reported.
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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