Registration Dossier
Registration Dossier
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EC number: 203-208-1 | CAS number: 104-50-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17th April 2000 - 28th April 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octan-4-olide
- EC Number:
- 203-208-1
- EC Name:
- Octan-4-olide
- Cas Number:
- 104-50-7
- Molecular formula:
- C8H14O2
- IUPAC Name:
- octan-4-olide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Haarmann & Reimer GmbH; 50529270
- Expiration date of the lot/batch: Arfived on 20.03.2000; stable for 1 year
- Purity: 99.2%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.0 - 2.7 kg b.w.
- Housing: Individually in PPO cages (floor area: 2576 sq.cm) with perforated floor
- Diet: A pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, wasavailable ad libitum
- 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:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hrs
- Number of animals or in vitro replicates:
- 4 female rabbits
- Details on study design:
- SCORING SYSTEM: Draize system
TOOL USED TO ASSESS SCORE:
The day before testing both eyes of the animals were examined with a hand held inspection lamp fitted with white and UV-light and magnifying glass with 2 x magnification to ensure there were no defects or irritation. The examination was performed before and after instillation of Fluorescein. Only the left eye was treated. The right eye remained untreated and served as control. 0.1 ml of the test article was placed in the left eye of the rabbits by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The lids were then gently held together for 1 second. The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24 hour reading Fluorescein was instilled. After rinsing with 20 ml 0.9% sodium chloride solution the eyes were examined again using UV-light to detect possible corneal darnage. The eyes were also examined 48 and 72 hours as well as 7 days after the treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: after instillation of Fluorescein
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 2, 3, 4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: 2, 3, 4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 2, 3, 4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3, 4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an in vivo eye irriation studies in rabbits, octan-4-olide was not irritating.
- Executive summary:
In a primary eye irritation study (2000072), 0.1mL of octan-4-olide (99.2%) was instilled into the conjunctival sac of the left eye of 4 female SPF albino rabbits. The eyes were examined and graded according to Draize at 1h, 24h, 48h, 72h, and on day 7 (one rabbit) and monitored up to 14 days.
Twenty-four hours after application of the test article animal 1 showed a scattered or diffuse area of opacity on more than half, but less than three quarters of cornea, a diffuse crimson red conjunctiva with individual vessels not easily discemible and a swelling above normal. In animal 2 were observed some conjunctival vessels definitely injected and a swelling above normal. Animals 3 and 4 showed some conjunctival vessels definitely injected. Forty-eight hours after application of the test article all four animals showed some conjunctival vessels definitely injected. Seventy-two hours after application of the test article animal 1 showed some conjunctival vessels definitely injected. The other three animals were free of any signs of eye irritation. Seven days after application of the test article anirnal 1 was free of any signs of eye irritation, too.
The following mean values were obtained: cornea opacity 0.1; iris lesion 0.0; redness of conjunctiva 0.8 and oedema of conjunctiva (chemosis) 0.2
In this study, octan-4-olide is not an eye irritant to the eye based on the the current UNSCEGHS Guidance (adopted in June 2011).
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