Registration Dossier
Registration Dossier
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EC number: 905-964-4 | CAS number: -
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Lack of details on test substance, lack of tabulation of individual scores and occlusive dressing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test substance, lack of tabulation of individual scores and occlusive dressing
- GLP compliance:
- yes
Test material
- Reference substance name:
- Triacetin
- EC Number:
- 203-051-9
- EC Name:
- Triacetin
- Cas Number:
- 102-76-1
- Molecular formula:
- C9H14O6
- IUPAC Name:
- propane-1,2,3-triyl triacetate
- Details on test material:
- - Name of test material (as cited in study report): Triacetin
- Physical state: clear, colourless liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrusse, Chbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult
- Weight at study initiation: 2312.5 g
- Housing: individual housing
- Diet: Zucht-/Haltungsdiät 20 ZH 5 (Nohrling GmbH, Bad Salzufen, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12
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(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin; 2.5 cm x 2.5 cm
- Type of wrap if used: linen patch covered by a plastic foil, fixed by adhesive tapes and acrylastic band.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 4 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Only 1 out of 4 tested animals showed a mild erythema 1 h after application. Therefore, a tabulation of the scores was not given.
- Other effects:
- No other 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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