Registration Dossier
Registration Dossier
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EC number: 200-683-7 | CAS number: 68-26-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- RCC
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
- IUPAC Name:
- O~15~-propionylretinoic acid
- 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 was approximately 90%.
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
2 males, 1 female
- Source: Kleintierfarm Madoerin AG, Füllinsdorf (Switzerland)
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.4-2.6 kg
- Diet: ad libitum
- Water: ad libitum
- 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:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- The skin reaction was assessed at 1, 24, 48 and 72 hours and at 7 and 14 days intervals after removal of the application patches.
- Number of animals:
- 3
- Details on study design:
- One half millilitre of the undiluted, liquid test substance was applied (under semiocclusive conditions) onto both intact and abraded sites of the doral skin of each rabbit.
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: a surgical gauze that 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
- Time after start of exposure: 4 hours
At the end of the exposure period, the application patches and coverings were removed and the skin was flushed with water.
SCORING SYSTEM: according to OECD guideline
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:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: epidermal lesions, scabbing, scaling or desquamation observed in 3/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: epidermal lesions, scabbing, scaling or desquamation observed in 3/3 animals
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 1 0 c
2 1 0 c
3 1 0 1.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 2 0
2 1 0
3 2 0 1.67 c
- - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 2 0
2 2 0
3 2 1 2.33 c
- - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 3 0 S
2 3 0 S
3 2 2 3.33 c
- - - - - - - - - - - - - - - - - - - - - - - - -
7-day reading
1 1 0
2 1 0
3 2 0 1.33 c/EL
- - - - - - - - - - - - - - - - - - - - - - - - -
14-day reading
1 0 0
2 0 0
3 0 0 0.00
-------------------------------------------------
Mean scores 24 - 72 h reading
Animal Erythema Edema
-----------------------------
1 2.3 0.0
2 2.0 0.0
3 2.0 1.0
- - - - - - - - - - - - - - -
Mean scores 24 - 72 h reading
Animal Erythema Edema
-----------------------------
1-3 2.1 0.3
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 c
2 1 0 c
3 1 0 1.00 c
- - - - - - - - - - - - - - - - - - - - - - - -
24-hour reading
1 1 0
2 1 0
3 2 0 1.33 c
- - - - - - - - - - - - - - - - - - - - - - - - -
48-hour reading
1 2 0
2 1 0
3 2 1 2.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
72-hour reading
1 2 0 S
2 2 0 S
3 3 2 3.00 c
- - - - - - - - - - - - - - - - - - - - - - - - -
7-day reading
1 0 0
2 1 0
3 2 0 1.00 c/EL
- - - - - - - - - - - - - - - - - - - - - - - - -
14-day reading
1 0 0
2 0 0
3 0 0 0.00
-------------------------------------------------
Abrreviations used for symptoms:
c = Colouring or staining of the skin by pigment or colouring of the test substance
S = desquamation
EL = epidermal lesions, scabbing, scaling
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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