Registration Dossier
Registration Dossier
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EC number: 230-363-2 | CAS number: 7069-42-3
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: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1989
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:
- Vitamin-A-propionate
- IUPAC Name:
- Vitamin-A-propionate
- Reference substance name:
- Retinyl propionate
- EC Number:
- 230-363-2
- EC Name:
- Retinyl propionate
- Cas Number:
- 7069-42-3
- Molecular formula:
- C23H34O2
- IUPAC Name:
- retinyl propionate
- Details on test material:
- Vitamin A propionate (CAS No. 7069-42-3) (2.5 mio IU/g; ca. 900 mg Vitamin A propionate/g); purity at least 90%.
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: 14 -15 weeks
- Weight at study initiation: 2.6 -2.9 kg
- Housing: individual
- Diet :e.g. ad libitum
- Water: e.g. ad libitum
- Acclimation period: Four days under laboratory conditions after veterinary examination .
Standard Laboratory Conditions:
Air-conditioned with 10-15 air changes per hour and hourly monitored environment with temperature 20+-3 degrees centigrade, relative humidity 40-70 %, 12 hours artificial fluorescent light/12 hours dark, music/light period .
Test system
- Vehicle:
- other: none or diethylphthalate
- Controls:
- no
- Amount / concentration applied:
- The undiluted test substance and a 30% solution in neantine (diethylphthalate) was applied.
Amount applied: 0.1 ml - Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after instillation of the test substance.
- Number of animals or in vitro replicates:
- 3 (2 males, 1 female)
- Details on study design:
- One tenth millilitre of the undiluted, liquid test substance was instilled into the conjunctival sac of the left eye of each rabbit. One tenth millilitre of the 30% solution was instilled into the conjunctival sac of the right eye of each rabbit. The eyes were not washed/ not rinsed.
SCORING SYSTEM: according to OECD guideline.
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
- 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
- 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
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Other effects:
- Yellow and slightly yellow staining of the eyelashes by pigment or coloring of the test article was observed all animals treated with the undiluted (100 %) test article, 1 hour after treatment (1/3 rabbit) and from 1 to 72 hours (2/3 rabbits) after treatment whereas all animals (3/3 rabbits)treated with the diluted (30%) test article showed yellow and slightly yellow staining within 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 0 0 0
2 0 0 0 0 0
3 0 0 1 0 1 0.33
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 0 0 0 0 0
2 0 0 0 0 0
3 0 0 1 0 1 0.33
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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) = 0.22 (mean of 3)
---------------------------------------------------------
Mean scores 24 - 72 h reading
Animal Cornea Iris Conjunctivae
Redness Chemosis
---------------------------------------------
1 0 0 0 0
2 0 0 0 0
3 0 0 0.7 0
Mean scores 24 - 72 h reading
Animal Cornea Iris Conjunctivae
Redness Chemosis
---------------------------------------------
1-3 0 0 0.2 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 2 0 2
3 0 0 1 0 1 1.67
- - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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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