Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-07-19 to 2010-10-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

12252-12-9

Cas Number:

12252-12-9

IUPAC Name:

12252-12-9

Constituent 2

Reference substance name:

Ettringite (Ca6[Al(OH)6]2(SO4)3.26H2O)

IUPAC Name:

Ettringite (Ca6[Al(OH)6]2(SO4)3.26H2O)

Details on test material:

- Name of test material (as cited in study report): Casul-Pulver getrocknet (Ettringit)
- molecular formula: Ca6[Al(OH)6]2(SO4)3.26H2O
- Substance type: white suspension
- Physical state: liquid/solid
- Lot/batch No.: R-Cl050609pH7
- Expiration date of the lot/batch: 2010-12-25
- Stability under test conditions: stable
- Storage condition of test material: room temperature
formulation of Casul-Pulver getrocknet (Ettringit) in water, 100 g/l, neutralized with sulfuric acid to pH7.0, which resulted in a content of dry mass of 102 g/l.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan GmbH, 4960 AD Horst, Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 165 g -198 g
- Fasting period before study: 16 -24 h
- Housing: group caged
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-2°C
- Humidity (%): 55+-5%
- Air changes (per hr): aspprox. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 100g/L
- Amount of vehicle (if gavage): 200 ml/kg bw.
- Justification for choice of vehicle: formulation for animal studies

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

2 groups of 3 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no signs of toxicity observed

Mortality:

no

Clinical signs:

other: no

Gross pathology:

no effect

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to EU Directive 67/548/EWG and EG Regulation 1272/2008 the test item is unclassified, GHS Category 5/ Unclassified.

Executive summary:

A liquid aqueous formulation of Casul-Pulver getrocknet (Ettringit) was administered in a dossage of 2000 mg/kg bw to 2 groups of 3 female Wistar rats by stomach tube. It was tolerated without clinical signs, effects on beody weight gain and gross pathological findings.