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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminium fluoride
EC Number:
232-051-1
EC Name:
Aluminium fluoride
Cas Number:
7784-18-1
Molecular formula:
AlF3
IUPAC Name:
aluminum trifluoride
Details on test material:
- Name of test material (as cited in study report): ALF, Aluminum fluoride (Chemical formula: ALF3)
- Physical state: solid
- Analytical purity: not reported
- Lot/batch No.: XP01_00008_01
- Expiration date of the lot/batch: Not reported
- Storage condition of test material: room temperature, in the dark

Test animals

Species:
rat
Strain:
other: Wistar (ordered as SPF-status) of the stock Mol:WIST
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: M & By Ejby, DK-4623 Lille Skensved, Denmark.
- Age at study initiation: not reported
- Weight at study initiation: 135-161 g
- Fasting period before study: overnight
- Housing: 2 or 3 animals per cage (transparent polycarbonate, macrolon type 111, floor area 810 cm²), males and females separated
- Diet (e.g. ad libitum): Altromin 131 4" from Chr. Petersen A/S, DK-4 100 Ringsted ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with HCl to pH 2.5 in order to prevent microbial growth ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): 10/hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 26 Jan. 2001 To: 09 Feb. 2001

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% CMC
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not reported
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: not reported
- Lot/batch no. (if required): not reported
- Purity: not reported


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
Sighting study: 500 and 2000 mg/kg bw
Main study: 2000 mg/kg bw
No. of animals per sex per dose:
Sighting study: 1 female each at 500 and 2000 mg/kg bw
Main study: 5 animals/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed at least 1, 3, and 6 hours after administration and daily thereafter; body weights recorded on days 1, 2, 3, 4, 8, and 15
- Necropsy of survivors performed: yes
Statistics:
None performed. The LD50 was greater than the highest dose tested.

Results and discussion

Preliminary study:
Sighting study: 1 female rat was given 500 mg AlF3/kg body weight. Since no clinical signs of evident toxicity were observed in this rat, another female rat was given 2000 mg AlF3/kg body weight. No signs of evident toxicity were observed in this rat.
Effect levels
Sex:
male/female
Dose descriptor:
LDLo
Effect level:
> 2 000 mg/kg bw
Mortality:
None of the animals died.
Clinical signs:
other: Sighting study: female receiving 500 mg/kg bw exhibited piloerection 1 and 3 hours after treatment with no other clinical signs of toxicity; female receiving 2000 mg/kg bw did not show any clinical signs of toxicity. Main study: piloerection was seen in
Gross pathology:
Post-mortem examinations revealed no abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC 1272/2008)