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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-07 to 2009-05-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Not yet available.
EC Number:
701-019-3
Molecular formula:
(Lu(1-x) Cex)3 Al(5-y) Gay O12, x= 0.005-0.05 and y= 0.1-1.5
IUPAC Name:
Not yet available.
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L173
- Substance type: inorganic
- Physical state: solid
- Analytical purity: presumably > 99.9 %
- Lot/batch No.: DP/SL 040c/09
- 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: 8 - 12 weeks
- Weight at study initiation (administration): males 311 - 360 g, females 208 - 216 g
- Housing: Semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days

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

IN-LIFE DATES: From: 2009-04-07 To: 2009-05-12

Administration / exposure

Type of coverage:
semiocclusive
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area
- % coverage: 10
- Type of wrap if used: Gauze dressing and non-irritating tape, fixed with an additional dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, lukewarm water
- Time after start of exposure: 24 h

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

VEHICLE
- Lot/batch no. (if required): B. Braun Melsungen, lot. no. 7494A191
- Purity: aqua ad injectionem
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 males, 5 females
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing on day 0, day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, 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:
other: No findings.
Gross pathology:
No special gross pathological changes

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. L173 is non-toxic via the dermal route according to CLP
Executive summary:

The acute dermal toxicity of L173 was assessed in a GLP guideline study according to OECD 402. 2000 mg/kg of the test item were applied on the skin of Wistar rats (5 females, 5 males). The exposure period was 24 h followed by an observation period of 14 days.

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

The substance is considered non-toxic via the dermal route.