Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
1988
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
RCC

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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%.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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