Pentaaluminium triyttrium dodecaoxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-12-09 to 2010-12-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentaaluminium triyttrium dodecaoxide

EC Number:

234-465-8

EC Name:

Pentaaluminium triyttrium dodecaoxide

Cas Number:

12005-21-9

Molecular formula:

Al5O12Y3

IUPAC Name:

pentaaluminium triyttrium dodecaoxide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): L181
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: VS 503G/10
- Expiration date of the lot/batch: not applicable
- Stability under test conditions: stable
- 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: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males 8 - 9 weeks, females 14 weeks
- Weight at study initiation (administration): males 248 - 252 g, females 208-230 g
- Housing: full barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 10 12 / 12
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: 2010-012-09 To: 2012-12-29

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

Aqua ad injectionem (Berlin Chemie, lot no. 01954, expiry date 04/2013)

Details on dermal exposure:

TEST SITE
- % coverage: ca. 10
- Type of wrap if used: additional dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; aqua ad injecionem
- Time after start of exposure: 24 h

TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: moisted with water

VEHICLE
- Lot/batch no. (if required): Berlin Chemie, lot no. 01954, expiry date 04/2013

Duration of exposure:

24 h

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 each

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing in day 1 (prior to application), day 8, day 15. A careful clinical observation was made several times on the day of dosing (at least during the first 30 minutes and with special attention given during the first 4 hours post dose). thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

Nasal discharge 1h, 2 h, 3 h and 4 h post dose which is not considered to be test-item related.

Body weight:

body weight [g] and body weight gain [%]
Animal No. / Sex day 1 day 8 day 15 % day 1 -15
21 / M 252 268 300 19
22 / M 252 279 314 25
23 / M 251 270 305 22
24 / M 248 272 300 21
25 / M 250 274 308 23
11 / F 227 223 228 0.4
12 / F 220 217 230 4.5
13 / F 208 206 210 1
14 / F 230 240 249 8
15 / F 220 217 229 4

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After an application period of 24 hours followed by an observation period of 14 days, no mortality and other adverse effects were observed. L181is non-toxic via the dermal route according to CLP

Executive summary:

The acute dermal toxicity of L181 was assessed in a GLP limit test according to OECD 402. 2000 mg/kg body weight of the test item were applied on the skin of Wistar rats (5 males, 5 females). The exposure period was 24 hours followed by an observation period of 14 days.

Erythema grade1 were observed in 2 of 5 female animals. Desquamination was observed in 1 of 5 female animals. Eschar was observed in 3 of 5 female animals. Scratches were observed in 3 of 5 female and 2 of 5 male animals. All sings of irritation were reversible within the observation period.

No mortalities and no treatment-related other adverse effects were observed.