Registration Dossier
Registration Dossier
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EC number: 609-521-3 | CAS number: 38109-77-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ethyl 3-amino-2-cyanoprop-2-enoate
- Cas Number:
- 38109-77-2
- Molecular formula:
- C6H8N2O2
- IUPAC Name:
- ethyl 3-amino-2-cyanoprop-2-enoate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Ethoxamide
- Physical state: almost white crystalline powder
- Lot/batch No.: 29
- Expiration date of the lot/batch: 05. 05. 2002
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Ferenc Sándor, address: Vörös Hadsereg 131, Kartal, H-2173, Hungary
- Age at study initiation: adult (about 11 weeks)
- Weight at study initiation: 2581-2773 g
at study termination 2696-2911 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, PURISTAR standard diet for rabbits (produced by AGRIBRANDS Europe)
- Water (e.g. ad libitum): tap water (for human cosumption) from automatic self-supplying watering system
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
0.5 g of Ethoxamide was applied on the test site in pure state in a single dose. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (examinations after the patch removal at 1, 24, 48, 72 hours)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ~6 cm2
- Type of wrap if used: sterile gauze patch, held loosely in place with adhesive but not irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the treatment period the rest of the test item was removed with body temperature water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 weeks
- Remarks on result:
- other: slight erythema
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Edema was not found.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1 - 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 2 weeks
- Remarks on result:
- other: well defined erythema
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0 - 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 2 weeks
- Remarks on result:
- other: slight edema
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- > 1 - < 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 weeks
- Remarks on result:
- other: 1 very slight, 1 well defined and 1 severe erythema
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- > 1 - < 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 weeks
- Remarks on result:
- other: 1 very slight edema, 1 moderate edema
- Irritant / corrosive response data:
- Combined irritation index was 1.73.
One week after the patch removal two animals were symptom-free. In the third case very slight erythema was observed and peeling still lasted.
Two weeks after the patch removal every animal was sympom-free. - Other effects:
- During the study the behaviour and general state of animals were normal.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion the substance applied to the rabbit's skin proved to be "moderately irritant" according to the observed irritation symptoms.
The observed skin irritation symptoms proved to be reversible alterations.
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