Registration Dossier

Diss Factsheets

Administrative data

Description of key information

In accordance with column 2 of REACH Annex VII and Annex VIII, acute toxicity studies do not need to be conducted since the substance is classified as corrosive to the skin. An existing non-GLP acute oral toxicity study (OECD Guideline 401) in rats suggested that the LD50 for tetrachloroauric(III) acid to be > 464 mg/kg bw. However, this was based on a study using testsolutions of very low pH and not neutralised as in other subsequent studies

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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 Available as an unpublished report.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.
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
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.
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
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.

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
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).

Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
464 mg/kg bw
Quality of whole database:
The study was conducted in 1993 under GLP and in accordance with test guideline OECD401. However, this guideline was later deleted in 2002.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In accordance with column 2 of REACH Annex VII and AnnexVIII, acute toxicity studies do not need to be conducted since the substance is classified as corrosive to the skin. A GLP acute oral toxicity study in rats was conducted in 1993 in accordance with OECD Guideline 401 (subsequently deleted in 2002) which suggested that the LD50 for tetrachloroauric(III) acid was > 464 mg/kg bw. The toxicity demonstrated in this study was considered to be related to the strong acidity of the test solutions since the formulation was not neutralised as in subsequent oral studies. The study is considered sufficient to meet the criteria for classification as acute toxicity under EC Regulation 1272/2008.

Justification for classification or non-classification

An existing non-GLP acute oral toxicity study (OECD Guideline 401) in rats suggested that the LD50 for tetrachloroauric(III) acid to be > 464 mg/kg bw. The study result meets the criteria for classification as acute toxicity under EC Regulation 1272/2008 (Acute Tox. Category 4 H302: Harmful if swallowed).