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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: see 'Remark'
Remarks:
This study is performed prior to the introduction of GLP and does not comply according to the current guidelines. The main objection is the fact that the test material was applied as a dry powder and not moistened sufficiently prior to application. As the substance is an insoluble organic pigment, this is considered acceptable.

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).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: LV 86

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Age at study initiation: adult
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit food -NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum water
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6: 3 male, 3 female
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 with the help of a "Schropfschnapper", Aesculap, Switzerland. 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. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

REMOVAL OF TEST SUBSTANCE
The dressings were removed after a 24 hour application.

SCORING SYSTEM:
The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of erythema and eschar formation and edema formation.
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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h & 4, 7 d
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h & 4, 7 d
Score:
0
Max. score:
4
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h & 4, 7 d
Score:
0
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h & 4, 7 d
Score:
0
Max. score:
4
Remarks on result:
other: abraded skin
Irritation parameter:
other: primary irritation index
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Irritant / corrosive response data:
The test substance was found to cause no irritation when applied to intact and abraded rabbit skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met