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EC number: 233-466-0 | CAS number: 10191-41-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 27, 1988 - September 30, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD Test Guideline No. 405, 1987 and under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
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)
- Version / remarks:
- Directive 84/449/EEC
- Deviations:
- not applicable
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
- EC Number:
- 233-466-0
- EC Name:
- 3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol
- Cas Number:
- 10191-41-0
- Molecular formula:
- C29H50O2
- IUPAC Name:
- 2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-3,4-dihydro-2H-1-benzopyran-6-ol
- Details on test material:
- - Name of test material (as cited in study report): D,L-alpha-Tocopherol
- Physical state: viscous oil
- Stability under test conditions: stable for at least 6 month
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fullinsdorf, Switzerland
- Age at study initiation:
Male: 14 weeks
Females: 15 weeks
- Weight at study initiation:
Male: 2.4 kg
Females: 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: ad libitum pelleted standard rabbit maintenance diet
- Water: ad libitum community tap water
- Acclimation period: Four days under laboratory conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10- 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%) - Duration of treatment / exposure:
- 72 hours (not rinsed)
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
SCORING SYSTEM: subjective numerical according to OECD Guideline 405 (corneal, iridic and conjunctival irritation (redness/chemosis)).
TOOL USED TO ASSESS SCORE: slit-lamp 30 SL/M and Varta Cliptrix diagnostic-lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- cumulative
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: Not rinsed
- Irritation parameter:
- other: Primary irritation score (100%)
- Basis:
- other: calculated by totaling the individual cumulative scores at 1, 24, 48 and 72 hours and then dividing by the number of figures
- Time point:
- other: 1, 24, 48 and 72 hrs.
- Score:
- 0
- Remarks on result:
- other: Not rinsed
- Irritant / corrosive response data:
- Coloration: Brown staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all three animals at 1 hour;
from 1 to 48 hrs., and from I to 72 hrs. after the test article application.
Corrosion: no corrosion of the cornea was observed at any of the measuring intervals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Primary Irritation Score = 0 = 1.2 Criteria used for interpretation of results: not specified
- Conclusions:
- Under the conditions of this experiment, D,L-alpha-Tocopherol was found to cause a primary irritation score of: 0.00, when applied to the rabbit eye mucosa.
Brown staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all three animals at 1 hour; from 1 to 48 hrs., and from 1 to 72 hrs. after the test article application.
No corrosion was observed at any of the measuring intervals. - Executive summary:
Single application of D,L-alpha-Tocopherol was well-tolerated on the rabbit eye (primary irritation score = 0.0).
Based on this result it can be expected that occasional contamination of the human eye by D,L-alpha-Tocopherol will be harmless for human health.
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