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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25th February 1992 to 17th March 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant, guideline study, available as an unpublished report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Potassium dicyanoaurate(I)
- Physical state: White crystalline powder
- Stability under test conditions: Stable throughout the experimental period
- Storage condition of test material: Dessicated in a closed container in a refrigerator

Test animals

Species:
rabbit
Strain:
other: White russian (Albino)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG. D-4802 Halle-Künsebeck
- Age at study initiation: Males: 5 months; Female: 7 months
- Weight at study initiation: Males: 2.10, 2.53 kg; Female: 2.42 kg
- Housing: Stainless steel cage with grating floor, type ASTA, size: 48.5x40x36.5
- Diet (e.g. ad libitum): ssniff K, Special diet for rabbits. Approx: 120 g/day per animal.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: One day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 - 22.5°C
- Humidity (%): 50 - 60%
- Photoperiod (hrs dark / hrs light): 6 a.m. - 6 p.m. CET artificial lighting, 6 p.m. - 6 a.m. CET darkness.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
test substance moisetened to ensure tight contact.
Controls:
other: The opposite area to the treatment on each animal was given a blank treatment, acting as a control.
Amount / concentration applied:
0.5 g
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE (demineralised water)
- Amount(s) applied (volume or weight with unit): 0.14 mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 (2 male, 1 female)
Details on study design:
TEST SITE
- Area of exposure:6.25 cm2 (patch size)
- Type of wrap if used: artifical wool coated with natural rubber layer and synthetic film glue layer. Bandage wrapped several times around the trunk (with 8cm) provided complete occlusion.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: DRAIZE Grade

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema and Eschar
Basis:
mean
Time point:
other: First 72 hours after exposure
Score:
2.33
Max. score:
4
Reversibility:
other: Disappeared in 2 out of the 3 animals by 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: First 72 hours after exposure
Score:
2.92
Max. score:
4
Reversibility:
other: Disappeared in 2 out of the 3 animals by 14 days.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: First 72 hours after exposure
Score:
5.3
Max. score:
8
Reversibility:
other: Effects disappeared in 2 out of the 3 animals by 14 days.
Remarks on result:
other: Sum of Erythema & Eschar and Edema score
Irritant / corrosive response data:
Severe changes in all animals
Other effects:
No systemic effects observed.

Any other information on results incl. tables

Table 1. Observed skin reactions to treatment

Reaction of the Exposed Skin Hours/Days after Exposure Draize Grade
Animal 1 Animal 2 Animal 3
Erythema and Eschar 1 h 2 3 2
24 h 2 3 2
48 h 2 3 2
72 h 2 3 2
4 d 2 3 2
7 d 2 3 2
14 d 0 1 0
Edema 1 h 4 4 4
24 h 2 3 3
48 h 2 3 3
72 h 1 3 3
4 d 1 3 3
7 d 1 3 2
14 d 0 1 0

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Gilman et. al (1983), Relationship between the Primary Dermal Irritation Index and Occular Irritation, J. Toxicol.-Cut. & Ocular Toxicol. 2, 107-117 (1983)
Conclusions:
Observation of the skin of rabbits after dermal application of potassium dicyanoaurate showed that the substance is severely irriating to the skin of the rabbit. No systemic effects were observed.
Executive summary:

Observation of the skin of rabbits after dermal application of potassium dicyanoaurate produced a primary irritation index of 5.3. Therefore, the substance is classified as severely irriating to the skin of the rabbit. No systemic effects were observed.