[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

test substance applied under occlusive conditions, observation period to short for assessment of full reversibility

GLP compliance:

no

Test material

Test material information

Constituent 1

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-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenyl] acetate

Details on test material:

Vitamin A acetate (CAS No. 127-47-9), purity 2.8 mio IU/g (ca. 860 mg Vitamin A acetate/g or 86%) in arachis oil.
Two specifications tested, i.e. Vitamin-A-Acetat and Vitamin-A-Acetat (external product). No furhter data available

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Weight at study initiation: individual animals: 3.61, 3.23 and 2.92 kg for the males and 2.91, 2.95 and 3.14  kg for females.
- Housing: single
- Diet (e.g. ad libitum): approx. 130 g per animal daily
- Water (e.g. ad libitum): approx. 250 ml per animal daily
- Acclimation period: approx. 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipping at least 15 hours before test substance administration

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin sites of  the same animals served as control. 

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

4 hour(s)

Observation period:

The skin was  scored at 30-60 minutes after removal of the test patches and at 24, 48,  72 hours, and 8 days after beginning of application.

Number of animals:

6 (3 male, 3 female)

Details on study design:

A test patch sized ca. 2.5 cm x 2.5 cm was soaked with approximately 0.5 ml of the test article and applied to the shaved dorsal skin of each animal under occlusive conditions for 4 hours. At the end of the exposure period,  the skin was washed with Lutrol and Lutrol/water (1:1).

Scoring according to OECD guideline.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1-6

Time point:

other: 24, 48 and 72 hours

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: in 5/6 animals

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1-6

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Any other information on results incl. tables

The result for Vitamin A acetate in arachis oil  is  presented

 in this entry. Comparable findings were observed for Vitamin A acetate (external product) (data not shown).

Table: Individual Draize scores and findings at intact skin sites

animal   eryth.   edema     symptoms
no
---------------------------------
4-hour reading
1         1         0         R:U
2         1         0         R:U
3         1         0         R:U
4         1         0         R:U
5         1         0         R:U
6         1         0         R:U
- - - - - - - - - - - - - - - - -
24-hour reading
1         2         1         R:U/OE:U
2         2         1         R:U/OE:U
3         2         1         R:U/OE:U
4         2         1         R:U/OE:U
5         2         1         R:U/OE:U
6         2         1         R:U/OE:U
- - - - - - - - - - - - - - - - -
48-hour reading
1         2         1         R:U/OE:U
2         2         1         R:U/OE:U
3         2         1         R:U/OE:U
4         3         1         R:U/OE:U
5         2         1         R:U/OE:U
6         3         1         R:U/OE:U/HE
- - - - - - - - - - - - - - - - -
72-hour reading
1         2         1         R:U/OE:U/HE
2         2         1         R:U/OE:U
3         2         1         R:U/OE:U
4         3         1         R:U/OE/U/HE
5         3         1         R:U/OE:U
6         3         1         R:U/OE:U/HE
- - - - - - - - - - - - - - - - -
8-day reading
1         1         0         S
2         1         0         S
3         1         0         S
4         0         0         S
5         1         0         S
6         1         0         S
---------------------------------
Abbreviations used for symptoms:
R:U = erythema exceeding the application area
OE:U = edema exceeding the application area
HE = hemorrhagic
S = desquamation

Mean scores 24 - 72 h reading
Animal  Erythema   Edema
-----------------------------
1       2.0        1.0
2       2.0        1.0
3       2.0        1.0
4       2.7        1.0
5       2.3        1.0
6       2.7        1.0
- - - - - - - - - - - - - - -
Mean scores 24 - 72 h reading
Animal  Erythema   Edema
-----------------------------
1-6     2.3        1.0