Registration Dossier
Registration Dossier
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EC number: 201-228-5 | CAS number: 79-81-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 18, 1988 - October 21, 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 Standards (EPA, USA, 1983, OECD, 1981)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- yes
- Remarks:
- No control; left (undiluted) eye; right (diluted) eye
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Directive 84/449/EEC
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- Vitamin-A-palmitat (retinyl palmitate)
- IUPAC Name:
- Vitamin-A-palmitat (retinyl palmitate)
- Reference substance name:
- Retinyl palmitate
- EC Number:
- 201-228-5
- EC Name:
- Retinyl palmitate
- Cas Number:
- 79-81-2
- Molecular formula:
- C36H60O2
- IUPAC Name:
- (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraen-1-yl hexadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Vitamine-A-Palmitate 1.7 ml mlU/g
- Physical state: Liquid
- Analytical purity: confidential
- Lot/batch No.: confidential
- Expiration date of the lot/batch: October, 1989
- Stability under test conditions: stable for at least 2 hours, stabilized with Tocopherol
Constituent 1
Constituent 2
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, Füllinsdorf (Switzerland)
- Age at study initiation:
Male: 14 weeks
Females: 15 weeks
- Weight at study initiation:
Male: 2.5 kg
females: 2.5-2.8 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 (ºC): 20 ± 3
- Humidity (%): 40 - 70
- Air changes (pr hour): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: No data
Test system
- Vehicle:
- other: unchanged (no vehicle, 100%) or diluted in neantine (diethylphtalate, 30%)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%) and diluted (30%) - 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:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24,48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: undiluted test substance
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: undiluted test substance
- Other effects:
- Yellow and slightly yellow staining of the eyelashes by pigment or coloring of the test article was observed in the animals treated with the undiluted (100 %) test article from 1 to 24 hours (1/3 rabbits), and from 1 to 72 hours (2/3 rabbits) after treatment. Yellow and slightly yellow staining was observed in all rabbits (3/3) treated with the diluted (30%) test article 1 hour after treatment.
Any other information on results incl. tables
Table 1: Individual Draize scores, cumulative scores (cumul score), and mean
cumulative scores (mean cum score) for the undiluted test substance(instilled
into the left eye without rinsing)
animal cornea iris conjunctivae cumul mean cum
no redn. chem. score score
---------------------------------------------------------
1-hour reading
1 0 0 2 0 2
2 0 0 2 0 2
3 0 0 2 0 2 2.00
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 0 0 1 0 1
2 0 0 0 0 0
3 0 0 0 0 0 0.33
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 0 0 0 0 0
2 0 0 0 0 0
3 0 0 0 0 0 0.00
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 0 0 0 0 0
2 0 0 0 0 0
3 0 0 0 0 0 0.00
---------------------------------------------------------
total mean score (24-72 h) = 0.33 (mean of 3)
---------------------------------------------------------
Mean scores 24 - 72 h reading
Animal Cornea Iris Conjunctivae
Redness Chemosis
---------------------------------------------
1 0 0 0.3 0
2 0 0 0 0
3 0 0 0 0
Mean scores 24 - 72 h reading
Animal Cornea Iris Conjunctivae
Redness Chemosis
---------------------------------------------
1-3 0 0 0.1 0
Table 2: Individual Draize scores, cumulative scores (cumul score), and mean
cumulative scores (mean cum score) for the 30% solution of the test substance
in diethylphthalate (instilled into the right eye without rinsing)
animal cornea iris conjunctivae cumul mean cum
no redn. chem. score score
---------------------------------------------------------
1-hour reading
1 0 0 2 0 2
2 0 0 1 0 1
3 0 0 1 0 1 1.33
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 0 0 0 0 0
2 0 0 0 0 0
3 0 0 0 0 0 0.00
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 0 0 0 0 0
2 0 0 0 0 0
3 0 0 0 0 0 0.00
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 0 0 0 0 0
2 0 0 0 0 0
3 0 0 0 0 0 0.00
---------------------------------------------------------
total mean score (24-72 h) = 0.00 (mean of 3)
---------------------------------------------------------
Applicant's summary and conclusion
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