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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Although it was not the intention to demonstrate skin corrosion in this OECD404 study, the unexpected result fulfilled the endpoint criteria.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 - 24 March 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline test, available as an unpublished report. Reliable without restriction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrachloroauric acid
EC Number:
240-948-4
EC Name:
Tetrachloroauric acid
Cas Number:
16903-35-8
Molecular formula:
AuCl4.H
IUPAC Name:
tetrachloroauric acid
Details on test material:
- Name of test material (as cited in study report): Tetrachloroauric(III)acid
- Physical state: Yellow, crumble pieces, extremely hygroscopic
- Analytical purity: 99.9% purity of the metal used for production of this compound.
- Lot/batch No.: 64
- Stability under test conditions: Stable throughout experimental period
- Storage condition of test material: Kept in ampoules that were welded in a refrigerator

Test animals

Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, D-33790 Halle/Westfalen
- Age at study initiation: 8 months
- Weight at study initiation: 2.32 kg
- Fasting period before study: Approx. 16 hours prior to treatment
- Housing: Macrolon cages, type II. Individual caging.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):as libitum
- Acclimation period: The animals were kept at least one day under test conditions prior to administration of the test substance.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 20.0°C
- Humidity (%): 50-58%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 6am - 6pm CET artificial lighting, 6pm - 6am CET darkness

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: no control animal: a similarly prepared patch without test substance on the other side of the animal was used as a control
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4 hours
Observation period:
Immediately after removal of the patch
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: Not calculated
- Type of wrap if used: Patch with two layers: Layer 1: Cellulose fabric coated with natural rubber, Layer 2: Synthetic film glue; Bandage: Acrylastic.


REMOVAL OF TEST SUBSTANCE
Animal was sacrificed immediately after removal of the patch


SCORING SYSTEM: Not used

Results and discussion

In vivo

Results
Irritation parameter:
other: Yellow and black discoloration of the skin, depression and slight oedema
Remarks:
Severe diffuse coagulation necrosis of the skin at the application site and subcutis and cutaneous muscle. Severe focal deposition of black granular particles at these sites and at reticulin fibres and skeletal muscle was also found.
Basis:
animal #1
Time point:
other: Immediately on patch removal after 4 hours
Reversibility:
not specified
Remarks on result:
other: Any indication of irritation was marked by severe signs of corrosion to the skin
Remarks:
Due to the severity of the reaction, only one animal was exposed and assessed.
Irritant / corrosive response data:
Multiple severe signs of corrosion were observed after removal of the patch at 4 hours.
Skin at and around application site was discoloured. Depression of skin at and around application site was observed. Subcutis around application site exhibited slight edema.
After euthanization of the animal a microscopical examimation of the application site showed:
*Severe diffuse coagulation necrosis of the skin and subcutis
*Severe focal coagulation necrosis of the cutaneous muscle
*Severe focal deposition of black granular particles, predominately at the periphery of the coagulation necrosis and at reticulin fibres and skeletal muscle
*Minimal focal inflammatory cell infiltrates

Applicant's summary and conclusion

Interpretation of results:
other: corrosive
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
Tetrachloroauric(III) acid was found to be corrosive to the skin of the rabbit.
Executive summary:

In a GLP compliant, guideline test, tetrachloroauric(III) acid was found to be corrosive to the skin of the rabbit.