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Registration Dossier
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EC number: 291-807-9 | CAS number: 90480-71-0
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:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail. The study is a read across from tetradecanol (CAS 112-72-1).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (based on)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetradecanol
- EC Number:
- 204-000-3
- EC Name:
- Tetradecanol
- Cas Number:
- 112-72-1
- IUPAC Name:
- 112-72-1
- Reference substance name:
- tetradecanol
- IUPAC Name:
- tetradecanol
- Details on test material:
- Tradename Lorol 14-98, MV626
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Strain:
- other: n/a
- Details on test animals or test system and environmental conditions:
- Age of the subjects was 22 - 53 years with an average of 34.9 years.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application.
- Number of animals:
- 20
- Details on study design:
- 15 drops/plaster of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of
healthy volunteers.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: n/a
- Irritant / corrosive response data:
- No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).
- Other effects:
- None reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Lorol C12-98 is not irritating to human skin following a 4 hour semi-occlusive exposure.
The study was conducted accordint to GLP. The result is a read across from tetradecanol (CAS 112-72-1).
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