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EC number: 200-353-2 | CAS number: 57-88-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Terrestrial toxicity
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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:
- june 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF guidelines (2000); including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cholesterol
- EC Number:
- 200-353-2
- EC Name:
- Cholesterol
- Cas Number:
- 57-88-5
- Molecular formula:
- C27H46O
- IUPAC Name:
- cholest-5-en-3-ol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): cholesterol
- Substance type: powder
- Physical state: solid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks
- Weight at study initiation: 1733 to 2267 grams
- Housing: individually inlabeled cages with perforated floors (Ebeco, germany) and shelters (Ebeco, Germany)
- Diet: ad libitum pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Italy); Hay (Technilab-BMI BV, The Netherlands) and wooden sticks (Swedish aspen wood, Bioservices, The Netherlands).
- Water: free access to tap water.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 June 2012 To: 22 June 2012
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): on average 21.6 mg (range 21.4-21.7 mg), a volume of approximately 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to guideline (scoring system presented in OECD 405
TOOL USED TO ASSESS SCORE: fluorescein (2% solution)
OTHER OBSERVATIONS: mortality/viability: twice daily; toxicity: at least once daily; body weight: before exposure and after the final observation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: mean of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- other: mean of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Instillation of approximately 0.1 mL cholesterol (approximately 22 mg) into one eye of each of three rabbits resulted in irritation of the conjunctivae (redness, chemosis and discharge). Irridial irritation grade 1 was observed for one animal at 1 hour after instillation. The irritation was fully reversible within 24, 48 or 72 hours in the respective animals. No corneal opacity nor corneal epithelial damage has been observed.
Remnants of the substance were present in the eyes of all animals at approximately 1 hour after instilation. - Other effects:
- No mortality and no symptoms of systemic toxicity were observed during the test period.
Any other information on results incl. tables
Mean value eye irritation scores (Mean 24, 48 and 72 hours ) |
||||
conjunctivae | ||||
Animal | corneal opacity | iris | redness | chemosis |
1 | 0.0 | 0.0 | 0.0 | 0.0 |
2 | 0.0 | 0.0 | 0.3 | 0.0 |
3 | 0.0 | 0.0 | 0.7 | 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results with the eye irritation study, cholesterol is considered non-irritating to eyes. As a result, cholesterol does not have to be classified and has no obligatory labelling requirements for eye irritation acoording to GHS and EU Regulation 1272/2008.
- Executive summary:
An eye irritation study with cholestrol was performed according to OECD and EC guidelines. Three rabbits received approximately 0.1 mL (approximately 22 mg) cholesterol in one eye. Irritation of the eye was scored after 1, 24, 48 and 72 hours after instillation of the substance in the eye.
Irritation of the conjunctivae (redness, chemosis and discharge) was observed. Iridial irritation grade 1 was observed for one animal at 1 hour after instillation. The irritation was fully reversible within 24, 48 or 72 hours in the respective animals. No corneal opacity nor corneal epithelial damage has been observed. Remnants of the substance were present in the eyes of all animals at approximately 1 hour after instilation. Based on these results, Cholesterol needs not to be classified and has no obligatory labelling requirements for eye irritation according to
-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),
-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
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