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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 April 1993 - 14 May 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant. Guideline study (OECD401) however the guideline was deleted in 2002. Available as an unpublished report. Acceptable with restrictions.

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 401 (Acute Oral Toxicity)
Deviations:
no
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

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 compund.
- Lot/batch No.: 64
- Stability under test conditions: Stable
- Storage condition of test material: In ampoules that were welded in a refrigerator

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 Versuchstierzucht GmbH & Co. KG., D-33176 Borchen
- Age at study initiation: Males: 8 weeks, Females: 9 weeks
- Weight at study initiation: Males: 201 - 224 g, Females: 158 - 179 g
- Fasting period before study: Appox. 16 hours prior to treatment.
- Housing: 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

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 22.5 °C
- Humidity (%): 39 - 68%
- Photoperiod (hrs dark / hrs light): 6 a.m. - 6 p.m. CET artifical lighting, 6 p.m. - 6 a.m. CET darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.15 mL/kg b.w.
Doses:
215, 464 mg/kg b.w.
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: mortality observed at 0.5, 1, 2, 4, 6, 24 hours and daily thereafter. Body weights recorded at days 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 464 mg/kg bw
Based on:
test mat.
Mortality:
At the 215 mg/kg b.w. treatment level one female was found dead at 24 hours
At the 464 mg/kg b.w. treatment level four males were found dead at 3 days.
Clinical signs:
Rats treated with 215 mg/kg bw exhibited slight hypokensia, piloerection, sunken sides, and stilted gait. Females additionally exibited coordination disturbances. One female, later found dead, displayed strenuous respiration. Survivors were observed to recover after 24 hours.
Rats treated with 464 mg/kg b.w. exhibited the above symptoms. Survivors recovered within 3 to 5 days with the exception of one female which had not fully recovered by day 14.
Body weight:
A reduction in body weight was observed in rats treated with 164 mg/kg b.w.
Gross pathology:
See table 1.

Any other information on results incl. tables

Table 1. Results of Macroscopical Examination

Organ/finding No. of animals at dose
215 mg/kg 464 mg/kg
Male surviving animals
Stomach wall: slightly thickened 0 1
No abnomalities detected 5 0
Male , deceased animals
Forestomach: focal hemorrage na 2
Stomach: severely distended, glandular stomach: wall hardedned, black-red discoloured, intestine: autolytic na 4
Female, surviving animals
Stomach wall: slightly thickened 0 5
Forestomach: white discoloured 0 1
Fusion of the stomach with the liver 0 1
No abnomalities detected 4 0
Female, deceased animals
Glandular stomach: hardened wall, dark-red discoloured, Stomach:black content, Lung and trachea: no abnormalities detected na 1

Applicant's summary and conclusion

Interpretation of results:
other: No interpretation of the results in presented in the report
Conclusions:
In a test where rats were administered with tetrachloroauric acid by gavage at rates of 215 and 464 mg/kg b.w., in neither group was there ≥50% mortality. Therefore the LD50 is determined to be >464 mg/kg b.w. Lethal and sublethal effects were seen at both dose levels which were considered a consequence of the strongly acidic nature of the test solutions.
Executive summary:

In a GLP-compliant, guideline test where rats were administered with tetrachloroauric acid by gavage at rates of 215 and 464 mg/kg b.w., in neither group was there ≥50% mortality over the course of 14 days. Therefore the LD50 is determined to be >464 mg/kg b.w. Lethal and sublethal effects were seen at both dose levels. The effects seen were considered to be a result of the strongly acidic test substance (pH of test solutions was not neutralised).

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