Registration Dossier
Registration Dossier
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EC number: 412-050-4 | CAS number: 125109-85-5 FLORHYDRAL
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- β-methyl-3-(1-methylethyl)benzenepropanal
- EC Number:
- 412-050-4
- EC Name:
- β-methyl-3-(1-methylethyl)benzenepropanal
- Cas Number:
- 125109-85-5
- Molecular formula:
- C13H18O
- IUPAC Name:
- 3-[3-(propan-2-yl)phenyl]butanal
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No. 8906-87
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5mL undiluted
- Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- The hair was clipped from the dorsal area of the trunk of each rabbit approx. 24 hoursbefore treatment. Care was taken to avoid abrading the skin.
The test material (0.5mL) was applied to the intact skin on each rabbit under a 2.5cm x 2.5 cm patch gauze. The patch was then covered with micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage which remained in position for 4 hrs. At the end of this period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material without altering the existing response or integrity of the epidermis.
Skin reactions were assessed 1, 24, 48 and 72hrs after patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight to well defined erythema was noted 1 hour to 48 hours after 4-hr semi-occluded exposure to the test item. No oedema was noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the individual scoring results, Florhydral does not need classification with regards to skin irritation.
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