Registration Dossier
Registration Dossier
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EC number: 203-533-9 | CAS number: 107-93-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1995-11-21 to 1995-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 92/67/EEC
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trans-crotonic acid
- EC Number:
- 203-533-9
- EC Name:
- trans-crotonic acid
- Cas Number:
- 107-93-7
- Molecular formula:
- C4H6O2
- IUPAC Name:
- but-2-enoic acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Y 01242250
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals:
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach
- Age at study initiation: 3-5 mounths
- Weight at study initiation: 3.4-3.7 kg
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/3 3 °C
- Humidity: 50-/- 20%
- Photoperiod: 12 hrs dark / 12 hrs light per day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Remarks:
- (0.3 mL per animal)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster
REMOVAL OF TEST SUBSTANCE
- Washing : warm tap water
- Time after start of exposure: immedialely after the 4-hour exposure period
SCORING SYSTEM: Draize
Reading:
30-60 min as well as 24,48 and 72 hours after removal of the patches. Because of the persistent irritations in two animals 72 hours after removal of the patches, additional readings were performed after 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- 30-60 min up to 3 days after removal of the plasters two animals showed very slight to well defined erythema and very slight oedema. The third animal exhibited neither erythma nor edema. 7 days after removal of the patches all signs of irritation were reversible.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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