Registration Dossier

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 Available as an unpublished report, acceptable without restrictions.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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

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
- Storage condition of test material: dry, cool

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPFCpb)
Sex:
male/female
Details on test animals 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 levelsopen allclose all
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
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
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:
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 additionally showed diarrhea, cyanosis. First symptoms appeared 15 minutes after administration and lasted for 1 to 2 days or until death.
Body weight:
See table 1.
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:
Toxicity Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.