Registration Dossier
Registration Dossier
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EC number: 201-228-5 | CAS number: 79-81-2
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)
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
- Remarks:
- Statement of Compliance
Test material
- Reference substance name:
- Vitamine A palmitate (retinyl palmitate)
- IUPAC Name:
- Vitamine A palmitate (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): Vitamin-A-Palmitate 1.7 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
Constituent 1
Constituent 2
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:
Male: 14 weeks
Females: 15 weeks
- Weight at study initiation:
Male: 2.6 kg
Females: 2.4 -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
IN-LIFE DATES: No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- 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:
- 1 male, 2 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin shaved 10 cm x 10 cm, abraded 2 .5 cm x 2 .5 cm; application of test article on intact and abraded skin of each animal
- Type of wrap if used: covered with a 3 .0 cm x 3 .0 cm patch of surgical gauze . The gauze was covered with filter paper and then covered with a
semi-occlusive dressing . The 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: 4 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:
- all animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 1.67
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)
animal eryth. edema mean cum symptoms
no score
-------------------------------------------------
1-hour reading
1 0 0
2 1 0 c
3 1 0 0.67 c
- - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 1 0
2 1 0
3 1 0 1.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 2 0
2 2 0
3 2 0 2.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 2 0 S
2 2 0
3 2 0 2.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
7-day reading
1 0 0 S
2 0 0
3 1 0 0.33
- - - - - - - - - - - - - - - - - - - - - - - - -
14-day reading
1 0 0
2 0 0
3 0 0 0.00
-------------------------------------------------
Mean scores 24 - 72 h reading
Animal Erythema Edema
-----------------------------
1 1.7 0.0
2 1.7 0.0
3 1.7 0.0
- - - - - - - - - - - - - - -
Mean scores 24 - 72 h reading
Animal Erythema Edema
-----------------------------
1-3 1.7 0.0
Table 2: Individual scores and mean cumulative scores (mean of n=3) at the
abraded skin (Draize scores); not relevant for safety assessment
animal eryth. edema mean cum symptoms
no score
-------------------------------------------------
1-hour reading
1 1 0
2 1 0 c
3 1 0 1.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 1 0
2 1 0
3 1 0 1.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 2 0
2 2 0
3 2 0 2.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 2 0 S
2 2 0
3 3 1 2.67 c
- - - - - - - - - - - - - - - - - - - - - - - - -
7-day reading
1 0 0 S
2 0 0
3 2 0 0.67
- - - - - - - - - - - - - - - - - - - - - - - - -
14-day reading
1 0 0
2 0 0
3 0 0 0.00
-------------------------------------------------
Abbreviations used for symptoms:
c = staining of the skin by pigment or colouring of the test substance
S = scaling
Reversible erythema and edema was observed,
fulfilling the critera as mild irritant according to UN-GHS criteria (Cat. 3)
Data on intact skin are used for assessment.
Applicant's summary and conclusion
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