Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-14 to 2009-04-18
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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 %
- 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:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 13 weeks
- Weight at study initiation: 3.0 kg, 3.8 kg, 3.1 kg
- Housing: Semi barrier in an air-conditioned room, housed in ABS - plastic rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 2009-04-09 To: 2009-04-18

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: Untreated right side of the body served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): enough for moistening the test item
- Lot/batch no. (if required): B. Braun Melsungen, lot 8221A121
- Purity: ca. 100 %
Duration of treatment / exposure:
Initial test: 4h
Main test: 4 h
Observation period:
For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
For the initial test in one animal, the test site was also examined immediately after the patch has been removed.
Number of animals:
Initial test: 1
Main test: 2
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: All 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
erythema score
Basis:
other: All 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
erythema score
Basis:
other: All 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
erythema score
Basis:
other: All 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
edema score
Basis:
other: All 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
edema score
Basis:
other: All 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
edema score
Basis:
other: All 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
edema score
Basis:
other: All 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: All 3 animals
Time point:
other: 1 h
Remarks on result:
other: no systemic findings, no specific local findings
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: All 3 animals
Time point:
other: 24 h
Remarks on result:
other: no systemic findings, no specific local findings
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: All 3 animals
Time point:
other: 48 h
Remarks on result:
other: no systemic findings, no specific local findings
Irritation parameter:
other: systemic findings, specific local findings
Basis:
other: All 3 animals
Time point:
other: 72 h
Remarks on result:
other: no systemic findings, no specific local findings

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritant, not corrosive.
Executive summary:

Under the conditions of the present study, single dermal application of the test item L173 to rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.

Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the criteria for classification and labelling requirements of the CLP-Regulation (as well as the DSD 2001/59/EC), the test item L173 does not have to be classified and has no obligatory labelling requirement for skin irritation.