Registration Dossier

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 Available as an unpublished report, acceptable without restrictions.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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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:
No clinical signs observed.
Body weight:
No effects on bodyweight.
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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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).