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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act
Principles of method if other than guideline:
- Principle of test: Draize Test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bismuth chloride oxide
EC Number:
232-122-7
EC Name:
Bismuth chloride oxide
Cas Number:
7787-59-9
Molecular formula:
BiClO
IUPAC Name:
chlorobismuthanone
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc., Denver, Pennsylvania, USA

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact or abraded
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 50%

Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (per intact and abraded skin)
Details on study design:
TEST SITE
- Area of exposure: On the back, (intact and abraded skin sites)
- Coverage square: One inch
- Type of wrap: Gauze patches

OBSERVATION TIME POINTS: 24 and 72 hours

SCORING SYSTEM:
- Method of calculation: J.H. Draize, Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics, Assoc. Food and Drug Officials of the U.S., Austin, Texas, 1959

Evaluation of Skin Reactions

Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Edema formation:
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate edema (raised approximately 1.0 mm.): 3
Severe edema (raised more than 1.0 mm. extending beyond the area of exposure): 4

The values-for erythema and eschar formation at 24 hours-and 72 hours for intact skin animals will be added to the values on abraded skin animals at 24 and 72 hours (four values). Similarly, the values for edema formation at 24 hours and at 72 hours for the intact and abraded skin animals will be added (four values). The primary irritant score is the total of the eight values divided by four. A primary irritant is one which results in a score of five or more as tested by this method.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
8

Any other information on results incl. tables

The skin irritation study was conducted according to the Federal Hazardous Substances Act.

0.5 mL of the test substance (formulation of 50% in water) was administered to six rabbits on the intact and abraded skin for 24 hours. At 24 and 72 hours observations were made, graded, and scored according to the system of J. H. Draize.

The primary irritation score for the test substancel was 0.0; therefore, the test substance is not a primary irritant under the conditions of this test.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified