Potassium dicyanoaurate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 5th - Novermber 21st 1991

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 Available as an unpublished report, acceptable without restrictions.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:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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

Details on test material:

- Name of test material (as cited in study report): Potassium dicyanoaurate(I)
- Physical state: White crystalline powder
- Storage condition of test material: dry, cool

Test animals

Species:

rat

Strain:

other: Bor: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchtierzucht GmbH & Co. KG., D-4799 Borchen
- Age at study initiation: Males: 8 weeks; Females: 9 weeks
- Weight at study initiation: Males: 138 - 168 g; Females: 137 - 148 g
- Fasting period before study: Approx. 16 hours
- Housing: 1 animal per cage. Macrolon cages (type II).
- Diet (e.g. ad libitum): ssniff R, Special diet for rats. ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ≥5 days under test conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23°C
- Humidity (%): 40 - 60%
- Photoperiod (hrs dark / hrs light): 6 a.m.- 6 p.m. CET artififical lighting, 6 p.m. - 6 a.m. CET natural light-dark-rhythm.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

desalted water

Details on oral exposure:

VEHICLE
Test item in aqueous solution.

MAXIMUM DOSE VOLUME APPLIED: 2.5 ml/kg b.w.

Doses:

10.0, 21.5, 46.4 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation for mortalities: 0.5, 1, 2, 4, 6, 24 hours, daily thereafter; Weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

LD50 values calculated by Probit analysis

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

36.1 mg/kg bw

Based on:

test mat.

95% CL:

14.6 - 66.9

Remarks on result:

other: Slope of dose response curve: 7.76

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

24.4 mg/kg bw

Based on:

test mat.

95% CL:

12.6 - 50.8

Remarks on result:

other: Slope of dose response curve: 4.56

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

29.2 mg/kg bw

Based on:

test mat.

95% CL:

21.7 - 39.8

Remarks on result:

other: Slope of dose response curve: 6.45

Mortality:

At the 21.5 mg/kg treatment level 2 females were found dead at 24 hours.
At the 46.4 mg/kg treatment level 1 male was found dead at 4 hours. 3 further males and 5 females were found dead at 24 hours.

Clinical signs:

other: No clinical signs were observed in the 10.0 mg/kg b.w. treatment group. At higher doses rats of both sexes showed slight to moderate hypokinesia, restrained gait, piloerection, clonic convulsions and sunken sides. One male in the 46.4 mg/kg group addition

Gross pathology:

No macroscopic changes were observed in animals surviving at 14 days.
Of those that had died earlier male animals showed reddened small intestine and glandular stomach whilst females showed severely bloated stomach and hemorrages were found in the glandular stomach. Male and females exhibited stomachs that were tightly filled with liquid.

Any other information on results incl. tables

Table 1 - Body weights of the individual animals.

Dose (mg/kg)	Animal No.	Day 0	Day 7	Day 14
Males
10	1	153	197	222
	2	156	201	239
	3	155	204	235
	4	160	204	233
	5	157	206	237
21.5	11	167	200	246
	12	156	192	233
	13	158	183	213
	14	159	195	234
	15	168	215	260
46.4	21	160	189	221
	22	164
	23	164
	24	158
	25	138
Females
10	6	137	153	158
	7	148	178	193
	8	145	155	158
	9	141	166	173
	10	142	165	170
21.5	16	141	152	166
	17	144	156	165
	18	145
	19	140
	20	143	159	167
46.4	26	145
	27	148
	28	146
	29	145
	30	140

Applicant's summary and conclusion

Interpretation of results:

Category 2 based on GHS criteria

Conclusions:

In a 14 day acute toxicity test on male and female rats the LD50 of potassium dicyanoaurate was found to be 29.2 mg/kg.

Executive summary:

In a 14 day acute toxicity test on male and female rats the LD50 of potassium dicyanoaurate was found to be 29.2 mg/kg. The female rats in the study were found to be more sensitive than the males.

The study was conducted to GLP standards and in accordance with standard guidelines.