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EC number: 813-782-0 | CAS number: 5912-87-8
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- Aquatic toxicity
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- Toxicological Summary
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- Irritation / corrosion
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 September to 09 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Programme (inspected on June 17, 2015 / signed on September 24, 2015)
Test material
- Reference substance name:
- (E)-2-Methoxy-4-prop-1-en-1-ylphenyl acetate
- EC Number:
- 813-782-0
- Cas Number:
- 5912-87-8
- Molecular formula:
- C12H14O3
- IUPAC Name:
- (E)-2-Methoxy-4-prop-1-en-1-ylphenyl acetate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: White crystalline powder
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 3.04-3.42 kg
- Housing: Animals were housed individually in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Envigo RMS (UK) Limited, Oxon, UK), ad libitum.
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: 14 September to 09 October 2015
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (approximately 92 mg)
- Concentration: undiluted - Duration of treatment / exposure:
- No washing was done.
- Observation period (in vivo):
- 1, 24, 48 and 72 h after instillation of test item
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize scale as described in the OECD guideline No. 405.
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2 and #3
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- - No corneal or iridium effects were noted during the study.
- Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Moderate conjunctival irritation was noted in two treated eyes and minimal conjunctival irritation was noted in one treated eye at the 24 hour observation with minimal conjunctival irritation noted in all treated eyes at the 48 hour observation.
- All treated eyes appeared normal at the 72 hour observation.
- The individual mean scores for corneal opacity and iritis was 0.0 for all animals. The individual mean scores for the conjunctivae were 1.0/1.0/1.0 for reddening and 0.3/0.7/0.7 for chemosis. - Other effects:
- One animal showed no gain in body weight and two animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table 7.3.2/1: Irritant/corrosive response data each animals at each observation time
Score at time point / Reversibility |
Cornea Opacity (/4) |
Iris (/2) |
Conjunctivae |
||
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
|||
1 h |
0 / 0 / 0 |
0 / 0 / 0 |
2 / 2 / 2 |
1 / 2 / 2 |
1 / 1 / 1 |
24 h |
0 / 0 / 0 |
0 / 0 / 0 |
2 / 2 / 2 |
1 / 1 / 1 |
0 / 1 / 1 |
48 h |
0 / 0 / 0 |
0 / 0 / 0 |
1 / 1 / 1 |
0 / 1 / 1 |
0 / 0 / 0 |
72 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Average 24, 48 and 72 h |
0.0 / 0.0 / 0.0 |
0.0 / 0.0 / 0.0 |
1.0 / 1.0 / 1.0 |
0.3 / 0.7 / 0.7 |
0.0 / 0.3 / 0.3 |
Reversibility |
- |
- |
completely reversible |
completely reversible |
completely reversible |
Average time for reversion |
- |
- |
72 h |
72 h |
48 h |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an eye irritation study performed according to the OECD Guideline No. 405, and in compliance with GLP, 0.1 mL (approximately 92 mg) of test item was instilled into the right eye of three male New Zealand White rabbits. The left eye remained untreated and served as control. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test item, and then released. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.
No corneal or iridium effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Moderate conjunctival irritation was noted in two treated eyes and minimal conjunctival irritation was noted in one treated eye at the 24 hour observation with minimal conjunctival irritation noted in all treated eyes at the 48 hour observation. All treated eyes appeared normal at the 72 hour observation.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 /1.0 /1.0 for redness, 0.3 /0.7 /0.7 for chemosis, 0/0/0 for iris lesions and 0/0/0 for corneal opacity.The effects observed were all reversible within 72 hours.
Under the test conditions, the test item is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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