Registration Dossier
Registration Dossier
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EC number: 819-688-6 | CAS number: 219828-90-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Oct 2012 - 09 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- methyl 2-[(prop-2-en-1-yloxy)methyl]prop-2-enoate
- EC Number:
- 819-688-6
- Cas Number:
- 219828-90-7
- Molecular formula:
- C8H12O3
- IUPAC Name:
- methyl 2-[(prop-2-en-1-yloxy)methyl]prop-2-enoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co. Ltd
- Age at study initiation: 21 weeks
- Weight at study initiation: 3.81 kg
- Housing: metal bracket-type cages (350 W x 500 D x 350 H, mm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 44 - 60%
- Air changes (per hr): 8 -13 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL/section
- Concentration (if solution): according to test guideline
VEHICLE
- Amount(s) applied: 0.5mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hr, 24 hr, 48 hr, 72 hr, and 4 days
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton swab soaked with tepid water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- 1 hr, 24 hr, 48hr, 72hr, 4 days
SCORING SYSTEM: macroscopic observation of the skin
- Method of calculation: according to the globalyl harmonised system of classification and labelling of chemicals (GHS) criteria for skin corrosion/irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 0 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 48hr, 72hr, 4 days
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 0 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1hr, 24,hr, 48hr, 72hr, 4 days
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- At the sites treated with Methyl 2-(Allyloxymethyl)Acrylate, very slight erythema (score 1) accompanied by very slight oedema (score 1) was noted immediately after patch removal.
This irritative change worsened over time, and severe erythema (beet-redness) to eschar formation preventing grading of erythema (score 4) accompanied by severe oedema (score 4), indicating hemorrhagic eschar, was noted by 72 hours after patch removal.
This change was also found 4 days after patch removal.
Methyl 2-(Allyloxymethyl)Acrylate was classified as category 1 according to the the GHS criteria for skin irritation/corrosion.
On the basis of these results, it was concluded that Methyl 2-(Allyloxymethyl)Acrylatehas skin corrosion potential.
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