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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25.01.2010-09.04.2010
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:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure

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:
Aluminium calcium hydroxid sulfate hexacosahydrat
IUPAC Name:
Aluminium calcium hydroxid sulfate hexacosahydrat
Details on test material:
- Name of test material (as cited in study report): Casul-Pulver getrocknet (Ettringit)
- Chemical name: Aluminium calcium hydroxid sulfate hexacosahydrat (Ca6[Al(OH)6]2(SO4)3.26H2O)
- Substance type: white powder
- Physical state: solid
- Analytical purity: 98%
- Lot/batch No.: R-CL250609
- Expiration date of the lot/batch: 25.06.2011
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan GmbH, 5960 AD Horst, Netherlands
- Age at study initiation: 9-13 weeks
- Weight at study initiation: males: 278-289 g, females: 232-245 g
- Fasting period before study: no
- Housing: individually
- 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): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6.0 x 5.0 cm²
- % coverage: 10%
- Type of wrap if used: Peha-Haft

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw.
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw.
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on tne day of application and subsequently at least once daily for an observation period of 14 days
- Frequency of weighing: once weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no
Body weight:
no significant effects
Gross pathology:
no particular findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Executive summary:

Groups of 5 male and female Wistar rats recieved a single dermal dose of 2000 mg/kg bw. of the test item applied semiocclusively for 24 hours.

The dose was tolerated by male and female rats without mortalities, clinical signs, effects on bodyweight development and gross pathological findings.