Potassium dicyanoaurate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, follows standard guidelines. Available as an unpublished report, acceptable without restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium dicyanoaurate

EC Number:

237-748-4

EC Name:

Potassium dicyanoaurate

Cas Number:

13967-50-5

Molecular formula:

C2AuN2.K

IUPAC Name:

potassium dicyanoaurate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Potassium dicyanoaurate
- Molecular formula (if other than submission substance): KAu(CN)2
- Substance type: White powder
- Physical state: Solid
- Stability under test conditions: stable under standard conditions.
- Storage condition of test material: At room temperature.

Test animals

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 258 - 268 g (males), 222 - 252 g (females)
- Fasting period before study: Yes, feeding discontinued approx. 16 hours before administration of test item.
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus) with granulated textured wood (Granulat A2, J. Brandenburg, Germany) as bedding material.
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) ad libitum with exception of 16 h fasting period before administration of test item.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15%
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h light (about 150 lux at approx. 1.5 m room height)

IN-LIFE DATES: From: 17 July 2014 To: 24 July 2014

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

Aqua ad iniectabilia

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 x 6 cm
- % coverage: 10 %
- Type of wrap if used: 8 layers gauze covered with a plastic sheet and secured with adhesive plaster.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No, residues of test item were not removed.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.7255 mL/kg b.w. preparation based on volume. 10 g Potassium dicyanoaurate mixed with 5 g water resulting in suspension with the density of 1.7386 g/mL.
- Concentration (if solution): 2000 mg/kg b.w.
- Constant volume or concentration used: no
- For solids, paste formed: no, suspension with a density of 1.7386 g/mL was used.

Duration of exposure:

Exposure time was 24 hours.

Doses:

One dose level of 2000 mg/kg b.w. was examined.

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before and immediately, and 5, 15, 30, 60 min, as well as 3, 6, and 24 hours after application of test item.
- Necropsy of survivors performed: yes
- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on mortality were made at least once daily. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded. The skin was observed for the development of erythema and oedema. At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities observed during the test.

Clinical signs:

other: No clinical signs observed.

Gross pathology:

No macroscopic findings observed at necropsy.

Any other information on results incl. tables

Table 1. Summary of effects

Symptoms/Criteria	Potassium dicyanoaurate 2000 mg/kg b.w. (n=5)
	males	females
Clinical signs	None	None
Skin reactions	None	None
Mortality 6 h	0	0
24 h	0	0
7 d	0	0
14 d	0	0
Mean body weight gain (g) Start	264.6	237.2
After 7 d	297.6 (+12.5)	238.8 (+0.7)
After 14 d	351.6 (+32.9)	256.8 (+8.3)
Inhibition of bodyweight gain	None	None
Necropsy findings	None	None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the EC-Commission directive 67/548/EEC and its subsequent amendments Potassium dicyanoaurate requires no labelling.
The test material is not classified for acute dermal toxicity according to the EC Regulation 1272/2008 and subsequent regulations and according to the Globally Harmonized Classification System (GHS).

Executive summary:

Acute dermal toxicity study of Potassium dicyanoaurate was according to OECD guideline 402 and EC method B.3 in rats. The test was conducted according to GLP.

The test item Potassium dicyanoaurate was applied dermally, on the shaved intact dorsal skin to rats once for 24 hours. This treatment was followed by an observation period of 2 weeks.

Under the test conditions, a single dermal administration of 2000 mg Potassium dicyanoaurate/kg b.w. did not reveal any signs of toxicity. No animal died prematurely. All animals gained the expected weight throughout the whole experimental period. The LD50 was determined to be >2000 mg/kg b.w. According to the EC-Commission directive 67/548/EEC and its subsequent amendments Potassium dicyanoaurate requires no labelling. The test material is not classified for acute dermal toxicity according to the EC Regulation 1272/2008 and subsequent regulations and according to the Globally Harmonized Classification System (GHS).