Registration Dossier
Registration Dossier
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EC number: 259-370-9 | CAS number: 54839-24-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (EU Method B.4 and OECD 404).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Eu Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethoxy-1-methylethyl acetate
- EC Number:
- 259-370-9
- EC Name:
- 2-ethoxy-1-methylethyl acetate
- Cas Number:
- 54839-24-6
- Molecular formula:
- C7H14O3
- IUPAC Name:
- 2-ethoxy-1-methylethyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Ethoxypropyl acetate
- Physical state: Liquid
- Analytical purity: > 98.5%
- Storage condition of test material: At ambient temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Each animal was identified by a numbered aluminium tag placed through the edge of one ear.
- Source: Rosemead Rabbits, Rosemead, Essex, UK
- Age at study initiation: Approximately 10 to 11 weeks
- Sex: males
- Weight at study initiation: 2.2 to 2.5 kg
- Housing: Individually in metal cages with perforated floors
- Diet: Ad libitum access to SDS Standard Rabbit Diet
- Water: Ad libitum access to tap water
- Acclimation period: Animals were acclimated to the laboratory environment (period not stated)
ENVIRONMENTAL CONDITIONS
- Temperature: Approximately 19 degrees C
- Humidity: 30 – 70 % relative humidity
- Air changes: Approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
IN-LIFE DATES: From: 30 July, 1985 To: 2 August, 1985
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches), and on Days 2, 3 and 4.
- Number of animals:
- Three.
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square
- % coverage:
- Type of wrap if used: Guaze pad occluded with ‘Elastoplast’ elastic adhesive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water
- Time after start of exposure: 4 hours after treatment
SCORING SYSTEM:
Erythema and eschar formation (Grades 0 – 4)
Oedema formation (Grades 0 – 4)
Other lesions described
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72hrs
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean of 3 animals tested. Maximum score observed 1.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72hrs
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Mean of 3 animals tested. Maximum score observed 1.
- Irritant / corrosive response data:
- Very slight (Grade 1) erythema, with or without very slight oedema was seen in two animals on Days 2 and 3 only. These responses were completed resolved on Day 4. The remaining animal showed no observable response to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occlusive application of ethoxypropyl acetate to intact rabbit skin for 4 hours elicited very slight dermal irritation. Based on these results, ethoxypropyl acetate is not classified as an irritant, and does not require labeling with risk phrase R38: ‘Irritating to skin’.
- Executive summary:
In a guideline and GLP in vivo rabbit skin irritation study, a single semi-occlusive application of ethoxypropyl acetate for 4 hours elicited very slight dermal irritation. The response was well below the threshold for classification as a skin irritant.
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