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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:
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

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:
no
Body weight:
no effect
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.