Registration Dossier
Registration Dossier
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EC number: 224-580-1 | CAS number: 4418-26-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- (only basic information given; occlusive type of coverage, only 48 h observation period)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate
- EC Number:
- 224-580-1
- EC Name:
- Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate
- Cas Number:
- 4418-26-2
- Molecular formula:
- C8H7O4.Na
- IUPAC Name:
- sodium 1-(6-methyl-2,4-dioxo-2H-pyran-3(4H)-ylidene)ethanolate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- abraded skin was additionally tested, but not used for evaluation
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 48 h
Reading time points: 4, 24 and 48 h - Number of animals:
- 6
- Details on study design:
- TEST SITE
- Type of wrap if used: The patches (1.5 inch x 1.5 inch 12 ply gauze squares) were secured to the area by thin bands of adhesive tape. The entire trunks of the animals were then wrapped in clear plastic trunk bands.
REMOVAL OF TEST SUBSTANCE
- Washing: Test sides were washed with appropraite solvent
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
4, 24 and 48 h
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Very slight edema were observed after the exposure period at 4 h on abraded skin in all animals. These effects were fully reversible within 24 h.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of this skin irritation study the test substance was not irritating.
- Executive summary:
In a test for skin irritation, rabbits were exposed to test material (test site occluded), following detailed examinations, post-exposure, the test substance was demonstrated not to be irritating.
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