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EC number: 204-844-2 | CAS number: 127-47-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 18, 1988 - November 1, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to OECD Test Guideline No. 404, 1987 and under GLP Standards (EPA, USA, 1983, OECD, 1981)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- Retinyl acetate
- EC Number:
- 204-844-2
- EC Name:
- Retinyl acetate
- Cas Number:
- 127-47-9
- Molecular formula:
- C22H32O2
- 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 acetate
- Details on test material:
- - Name of test material (as cited in study report): Vitamin-A-Acetate 1.5 mlU/g (diluted with arachidis oil)
- Physical state: Liquid
- Analytical purity: Confidential
- Lot/batch No.: Confidential
- Expiration date of the lot/batch: May, 1990
- Stability under test conditions: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Füllinsdorf (Switzerland)
- Age at study initiation:
Males: 14 weeks
Female: 15 weeks
- Weight at study initiation:
Males: 2.6 - 2.8 kg
Female: 2.7 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 test 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped: intact and abraded skin was tested
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 2 males, 1 female
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin shaved 10cm x 10cm, abraded 2.5cm x 2.5cm; application of test article on intact and abraded skin of each animal
- Type of wrap if used: coverage with 3.0cm x 3.0cm surgical gauze patch, filter paper and semi-occlusive dressing. Dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: four hours
SCORING SYSTEM: subjective numerical according to OECD Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Table 1: Individual scores and mean cumulative scores (mean of n=3)
at the intact skin (Draize scores) used for assessment.
animal eryth. edema mean cum symptoms
no score
---------------------------------------------------
1-hour reading
1 0 0
2 1 0
3 1 0 0.67
- - - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 0 0
2 1 0 m
3 1 0 0.67
- - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 1 0
2 2 0 m
3 2 0 1.67
- - - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 2 0
2 2 0 m
3 2 0 2.00
- - - - - - - - - - - - - - - - - - - - - - - - - -
7-day reading
1 1 0 S/m
2 1 0 m
3 1 0 1.00
- - - - - - - - - - - - - - - - - - - - - - - - - -
14-day reading
1 0 0
2 0 0
3 0 0 0.00
---------------------------------------------------
Mean scores 24 - 72 h reading
Animal Erythema Edema
-----------------------------
1 1.0 0.0
2 1.7 0.0
3 1.7 0.0
- - - - - - - - - - - - - - -
Mean scores 24 - 72 h reading
Animal Erythema Edema
-----------------------------
1-3 1.4 0.0
Table 2: Individual scores and mean cumulative scores (mean of n=3) at
the abraded skin (Draize scores); not relevant for assessment
animal eryth. edema mean cum symptoms
no score
---------------------------------------------------
1-hour reading
1 1 0 m
2 1 0
3 1 0 1.00
- - - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 1 0 m
2 1 0 m
3 1 0 1.00
- - - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 2 0
2 2 0 m
3 2 0 2.00 S
- - - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 2 0 m
2 2 0
3 2 0 2.00 S
- - - - - - - - - - - - - - - - - - - - - - - - - -
7-day reading
1 1 0 S/m
2 1 0 m
3 1 0 1.00
- - - - - - - - - - - - - - - - - - - - - - - - - -
14-day reading
1 0 0
2 0 0
3 0 0 0.00
---------------------------------------------------
Abbreviations used for symptoms:
S = scaling
m = maculate
Applicant's summary and conclusion
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