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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Regarding the oral route, no mortality was observed within an observation period of 14 days in a limit test according to OECD guideline 401 using 5 female and 5 male Sprague Dawley rats.
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other:
Remarks:
GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment
Justification for type of information:
The read-across can be performed because trisodium hexafluoroaluminate is component parts of ADS 2-5, and is the only component with possible negative effects on human health. In view of this fact, we will detail its effect, based on published studies.
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
experimental study Regarding the oral route, no mortality was observed within an observation period of 14 days in a limit test according to OECD guideline 401 using 5 female and 5 male Sprague Dawley rats.
Adequacy of study:
weight of evidence
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other:
Remarks:
GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment
Justification for type of information:
The read-across can be performed because trisodium hexafluoroaluminate is component parts of ADS 2-5, and is the only component with possible negative effects for human health.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Label: CRIOLITE SINTETICA
Description: white powder
Batch No.: 11
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Starin: Cr1:CD (SD) BR rat
- Source: Charles River Italia S.p.A.
- Age at study initiation: about 7-9 weeks
- Weight at study initiation: males 225-250 g, females 200 - 225 g
- Housing: 5 animals/sex/cage in air-conditioned rooms
- Diet (e.g. ad libitum): GLP 4RF21 pelleted diet ad libitum
- Water (e.g. ad libitum): from the municipal water main system ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 20/hour
- Photoperiod (hrs dark / hrs light): 12 hours
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
deionized water, administrationvolume 20 ml/kg
Doses:
5000 mg/kg bw
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: at 30 minutes, 2, 4 and 6 hours on the first day after administration and then twice a day up to termination of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, clinical signs and mortality
(since no changes were found at necropsy, histological examination was not performed)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed on animals treated at 5000 mg/kg bw (limit dose) during the post-treatment observation period
Clinical signs:
other: Some of the animals showed piloerection starting 6 hours after administration. This sign lasted up to day 5. One male rat showed diarrhea, with short duration, at the 6 hour observation. All animals achieved recovery within day 6.
Gross pathology:
No appreciable macroscopic findings were observed
Interpretation of results:
GHS criteria not met
Remarks:
In accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for acute oral toxicity based on the available data.
Conclusions:
No adverse health effects have been reported in ADS 2-5 product preparation workers or in those using this product.
Executive summary:

LD50 exceeding 5000 mg/kg bw

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

impurity 1
Chemical structure
Reference substance name:
Trisodium hexafluoroaluminate
EC Number:
237-410-6
EC Name:
Trisodium hexafluoroaluminate
Cas Number:
13775-53-6
Molecular formula:
AlF6Na3
IUPAC Name:
trisodium hexafluoroalumanetriuide
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Cryolite
- Substance type: slighty coloured powder
- Analytical purity: 96.9%
- Composition of test material, percentage of components: Na 31%, Al 12.6%, F 53.3%
- Storage condition of test material: room temperature
Specific details on test material used for the study:
Synthetic Cryolite
powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Starin: Cr1:CD (SD) BR rat
- Source: Charles River Italia S.p.A.
- Age at study initiation: about 7-9 weeks
- Weight at study initiation: males 225-250 g, females 200 - 225 g
- Housing: 5 animals/sex/cage in air-conditioned rooms
- Diet (e.g. ad libitum): GLP 4RF21 pelleted diet ad libitum
- Water (e.g. ad libitum): from the municipal water main system ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 20/hour
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized water, administrationvolume 20 ml/kg
Doses:
5000 mg/kg bw
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: at 30 minutes, 2, 4 and 6 hours on the first day after administration and then twice a day up to termination of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, clinical signs and mortality
(since no changes were found at necropsy, histological examination was not performed)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed on animals treated at 5000 mg/kg bw (limit dose) during the post-treatment observation period
Clinical signs:
other: Some of the animals showed piloerection starting 6 hours after administration. This sign lasted up to day 5. One male rat showed diarrhea, with short duration, at the 6 hour observation. All animals achieved recovery within day 6
Gross pathology:
No appreciable macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
In accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for acute oral toxicity based on the available data.
Conclusions:
No adverse health effects have been reported in ADS 2-5 product preparation workers or in those using this product
Executive summary:

LD50 exceeding 5000 mg/kg bw