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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
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable for assessment
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG Gossau SG
- Water: water ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS

- Temperature: 22+ 1°C
- Humidity: 55+5%
- Photoperiod: 10 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g




Duration of treatment / exposure:
24 h
Observation period:
Up to 7 d
Number of animals:
six animals (Three males and three females)
Details on study design:
TEST SITE
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(intact skin)
Basis:
animal: Six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
erythema score
Remarks:
(Abraded skin)
Basis:
animal: Six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
edema score
Remarks:
(intact skin)
Basis:
animal: six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
edema score
Remarks:
(Abraded skin)
Basis:
animal: Six animals
Time point:
other: 24 and 72 h (mean)
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Irritant / corrosive response data:
No data
Other effects:
None

Any other information on results incl. tables

Calculation of the primary skin irritation index:

The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.

Time after exposure h mean reaction score of 6 rabbits  
erythema edema
intact skin  abraded skin intact skin abraded skin
24 0 0 0 0
72 0 0 0 0
subtotal 0 0 0 0
total 0        +       0      +        0      +          0    =     0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin.
Executive summary:

A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

Gauze patches of 2.5 x 2.5 cm laden with o.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure.

Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin.

The calculated primary irritation index was 0.