Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-20 to 2009-04-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye 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 > 99.9 %
- 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 3.1 kg, 4.1 kg, 3.3 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- acclimatisation: at least 5 days

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

IN-LIFE DATES: From: 2009-04-15 To: 2009-04-25

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No rinsing after application.
- Time after start of exposure: 72 h

SCORING SYSTEM: Grading of ocular lesion
Cornea: Degree of density (opacity, densest are taken for reading. Score 0 - 4
Iris: Score 0 - 2
Conjunctiva: Redness (refers to palpebral and bulbar conjunctiva; excluding cornea and iris. Score 0 - 3
Conjunctiva: Chemosis, swelling (refers to lids and/or nictitating membranes). Score 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: all 3 animals
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: all 3 animals
Time point:
other: 48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
iris score
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
other: all 3 animals
Time point:
other: 72 h
Score:
0

Any other information on results incl. tables

Control negative in all animals 1 h, 24 h, 48 h and 72 h after application.

No individual systemic and local findings (clinical signs of toxicity) were found in any of the 3 animals 1 h, 24 h, 48 h and 72 h after application of the test item.

The body weights of 2 animals remained constant throughout the observation period. The 3rd animal gained 0.1 kg body weight during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not irritating
Executive summary:

The eye irritating potential of L173 was examined in a GLP guideline study according to OECD 405.

Under the conditions of the present study, single ocular application of the test item L173 to rabbits at a dose of 0.1 g produced no irritant effects. Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria of DSD (Directive 2001/59/EC) and the CLP-Regulation (EC) 1272/2008, the test item L173 does not have to be classified for eye irritation.