Registration Dossier
Registration Dossier
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EC number: 256-367-4 | CAS number: 49553-76-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 12 Nov - 12 Dec 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (lack of study details, amount and concentration of test substance applied not specified and analytical purity of test substance not specified).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of study details, amount and concentration of test substance applied is not specified and analytical purity of test substance not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isooctadecanoic acid, mono-, di- and triesters with triglycerol
- EC Number:
- 291-548-1
- EC Name:
- Isooctadecanoic acid, mono-, di- and triesters with triglycerol
- Cas Number:
- 90431-25-7
- IUPAC Name:
- 90431-25-7
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Diisostearate De Polyglycerol 3
- Analytical purity: not given
- Lot/batch No.: 2811 K
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- other: not required, untreated sites of the same animal served as control
- Duration of treatment / exposure:
- not specified (4 hours according to OECD 404 which is given as Method)
- Observation period:
- 72 hours
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Only slight erythema was seen on skin of all three animals tested starting 1 hour following application and was fully reversible within 72 hours following application.
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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