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EC number: 259-370-9 | CAS number: 54839-24-6
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- Uses advised against
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye 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.5 and OECD 405).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- EU Method B.5 (Acute toxicity Eye 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): Ethyoxypropyl Acetate
- Physical state: Liquid
- Analytical purity: > 98.5%
- Storage condition of test material: At ambient temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 12 weeks
- Weight at study initiation: 2.2 – 2.7 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 (per hr): Approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light (0700-1900 hours) in each 24 hour period.
IN-LIFE DATES: From: 5 August, 1985 To: 12 August, 1985.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye of each animal remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml was placed into the everted lid of one eye of each animal. - Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3, 4, and 7 days after instillation.
- Number of animals or in vitro replicates:
- Two males and one female
- Details on study design:
- SCORING SYSTEM:
Cornea (Grade 0 – 4)
Iris (Grade 0 – 2)
Conjunctiva Redness (Grade 0 – 3)
Conjunctiva Chemosis (Grade 0 – 4)
Other lesions described
TOOL USED TO ASSESS SCORE:
Observation of the eyes was aided by the use of a handheld torch.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72hr
- Score:
- 0.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72hr
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- No corneal damage or iridial effect was observed in any animal at any time point. Maximum scores of Grade 2 redness (a diffuse crimson red colouration) and Grade 1 chemosis were observed in the conjuctiva of all three animals 1 hour following treatment. These changes were resolved in all animals by Day 3 following treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Grade 2 conjuctival redness was classified as a positive response in this study. On the basis of this finding all three animals were considered to have produced a positive response to ethoxypropyl acetate. The overall mean irritation scores at 24, 48 and 72 hours were not sufficient to require labeling under Annex VI of EEC directive 67/548/EEC with the risk phrase R36: ‘Irritating to Eyes’.
- Executive summary:
In an guideline and GLP in vivo rabbit eye irritation study (without washing at 24hrs), administration of 0.1 ml of ethyoxypropyl acetate produced maximum scores of Grade 2 redness and Grade 1 chemosis one hour following treatment. These changes were resolved in all animals by Day 3. No corneal damage or iridial inflammation was observed. The level of transient irritation produced was insufficient to meet the requirement for classification as an eye irritant.
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