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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June - July 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline- and GLP-compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminium triformate
EC Number:
230-898-1
EC Name:
Aluminium triformate
Cas Number:
7360-53-4
Molecular formula:
CH2O2.1/3Al
IUPAC Name:
aluminium triformate
Details on test material:
Test article: Altriform CFD
Chemical name: Aluminiumtriformiat
Article No.: 335204
Batch No.: 46799/01
Activity: approx. 97%
Description: White powder
Stability: 12 months

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DIMED Schönwalde GmbH, D-16352 Schönwalde
- Weight at study initiation: 140 - 160 g
- Fasting period before study: ca. 18 hours
- Housing: transparent polycarbonate cages (macrolone type III)
- Diet (e.g. ad libitum): Altromin 1314
- Water (e.g. ad libitum): domestic quality drinking water acidified with HCl to pH 2.5
- Acclimation period: at least 5 days


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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
Dose: 2000 mg/kg body weight
Dose volume: 10 mL/kg body weight

- Rationale for the selection of the starting dose:
The study was initiated with a sighting study: One female rat was dosed with 2000 mg/kg b.w. Only slight signs of toxicity and no mortality were observed.
Doses:
2000 mg/kg body weight
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: 1, 3 and 6 hours after the administration and daily thereafter for 14 days
- Frequency of weighing: Body weight was recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
Sighting study with one female, dosed with 2000 mg/kg: The animal survived the treatment, showed only slight signs of toxicosis (piloerection 1 and 3 h after administration) and had a normal body weight gain during the study period. No pathological abnormalities were revealed at the post mortem inspection.
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died on account of the treatment.
Clinical signs:
other: All animals showed piloerection 1 and 3 hours after the application of the test article. After 6 hours until the end of the observation period no abnormalities were revealed.
Gross pathology:
The gross necropsy of the animals revealed no pathological abnormalities.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the experimental conditions the discriminating dose level of Aluminiumtriformiat, Batch No. 46799/01, in rats was found to be 2000 mg/kg body weight (LD50, oral, rat > 2000 mg/kg bw).
Executive summary:

The acute oral toxicity in rats was determined according to the method recommended in the OECD Guideline No. 420, "Acute Oral Toxicity - Fixed Dose Method", July 1992 and the corresponding EEC Guideline B.1 bis "Acute Toxicity (Oral)", January 1997.

The study was initiated with a sighting study, in which one female rat was given Aluminiumtriformiat in a 2000 mg/kg body weight dose. Slight signs of toxicity were observed in this rat.

Based on the results from the sighting study the main study was carried out with one group consisting of 5 male and 5 female animals given a dose of 2000 mg/kg body weight.

All animals in the main study survived the treatment and showed only slight signs of toxicosis.

Under the experimental conditions the discriminating dose level of Aluminiumtriformiat, Batch No. 46799/01, in rats was found to be 2000 mg/kg body weight and the LD50 (oral, rat) was > 2000 mg/kg body weight..