Registration Dossier
Registration Dossier
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EC number: 203-013-1 | CAS number: 102-20-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-03-05 to 2001-03-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenethyl phenylacetate
- EC Number:
- 203-013-1
- EC Name:
- Phenethyl phenylacetate
- Cas Number:
- 102-20-5
- Molecular formula:
- C16H16O2
- IUPAC Name:
- 2-phenylethyl phenylacetate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: hbb:HM(SPF) — Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.3-3 kg b.w.
- Housing: The study took place in animal room No. 8 provided with filtered air. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 6 a.m. to 6 p.m. During a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO vages (floor area: 2576 sq.cm) with perforated floor.
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Other eye served as control
- Amount / concentration applied:
- 0.1 mL of the test article was applied undiluted
- Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 20 mL 0.9 % sodium chloride
- Time after start of exposure: After 24 hours
SCORING SYSTEM: According to Draize et al.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye irritation was investigated according to the method recommended in OECD guideline 405. 24, 48 and 72 hours after application of the test article all four animals were free of any signs of eye irritation.
- Executive summary:
The local effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/ Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997. Four female albino rabbits were exposed to 0.1 mL of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing. No signs of irritation were observed on the treated eyes. The following mean values, based on the results from the 24, 48 and 72 hour
readings, were calculated:
Cornea: 0
Iris: 0
Conjunctiva: 0
Chemosis: 0
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