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

Acute Toxicity: dermal

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

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:

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: no

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.