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EC number: 261-332-1 | CAS number: 58567-11-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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
- GLP compliance:
- yes
Test material
- Reference substance name:
- (ethoxymethoxy)cyclododecane
- EC Number:
- 261-332-1
- EC Name:
- (ethoxymethoxy)cyclododecane
- Cas Number:
- 58567-11-6
- Molecular formula:
- C15H30O2
- IUPAC Name:
- (ethoxymethoxy)cyclododecane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino rabbits of the stock Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre Ltd., Ejby, DK-4623 Lille Skensved
- Age at study initiation: not reported
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: caged single in PPL cages with perforated floor
- Diet (e.g. ad libitum): free access to feed pellets
- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The eyes were examined and the grade of ocular reaction was recorded 1 and 24 hours after application. After the first 24 hour reading, Fluoreszein was instilled. After rinsing with 20 mL 0.9% sodium chloride solution, the eyes were examined again using UV-light to detect possible corneal damage. The eyes were also examined 48 and 72 hours as well as on day 7 after the treatment.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
CORNEA:
Opacity degree of density (Area most dense taken for reading)
0: No ulceration or opacity
1: Scattered or diccuse area of opacity (other than slight dulling of normal luster), details of iris clearly visible.
2: Easily discernible translucent areas, details of iris slightly obscured.
3: Nacreous areas, no details of iris visible, size of pupil barely discernible
4: Complete corneal opacity, iris not discernible
Area of cornea involved
1: One quarter (or less) but not 0
2: More than 1 quarter, but less than half
3: More than half, but less than 3 quarters
4: More than 3 quarters, up to whole area
IRIS
0: Normal
1: Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof), iris still reacts to light (sluggish reaction is positive)
2: No reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVA
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0: vessels normal
1: Some vessels definitely injected
2: Diffuse, crimson red, individual vessels not easily discernible
3: Diffuse beefy red
Chemosis
0: No swelling
1: Any swelling above normal (includes nictitating membrane)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed
Discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs, and considerable area around the eye
TOOL USED TO ASSESS SCORE: hand held inspection lamp fitted with white and UV-light with 2 x magnification, fluorescein (after first 24 hour reading)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Applicant's summary and conclusion
- Interpretation of results:
- other: EU CLP criteria
- Remarks:
- not classified
- Conclusions:
- The substance was not irritating to the eye under the conditions of the test.
- Executive summary:
The primary eye irritant effect of the test substance was investigated according to OECD TG 405.
Three female albino rabbits were exposed to 0.1 mL of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48, 72 and on day 7 hours after dosing. After the treatment, only slight changes were observed in the eyes. The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated: Cornea opacity: 0/4, iris lesion: 0/2, redness of conjunctiva: 1/3, odema of conjunctiva: 0.8/4.
It is concluded that the test substance caused no eye irritation under the conditions of the test.
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