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Diss Factsheets

Administrative data

Description of key information

The substance lutetium aluminium oxide, cerium doped, garnet is not irritating to the skin and not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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
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
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
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 L174 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 L174 does not have to be classified and has no obligatory labelling requirement for skin irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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: 3.2 kg, 2.8 kg, 3.1 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
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
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:
chemosis score
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

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.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritating to the eye.
Executive summary:

The eye irritating potential of L174 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 L174 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 L174 does not have to be classified for eye irritation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The variation L174 was tested for the potential to cause skin irritation in a GLP guideline study according to OECD 404.

The substance did not exhibit skin irritation or skin corrosion.

The same irritative/corrosive profile is expected for other variations of the substance lutetium aluminium oxide, cerium doped, garnet.

The variation L174 was tested for the potential to cause eye irritation in a GLP guideline study according to OECD 405.

The substance did not exhibit eye irritation or eye corrosion.

The same irritative/corrosive profile is expected for other variations of the substance lutetium aluminium oxide, cerium doped, garnet.


Justification for selection of skin irritation / corrosion endpoint:
Available GLP guideline study

Justification for selection of eye irritation endpoint:
Available GLP guideline study

Justification for classification or non-classification

Lutetium aluminium oxide, cerium doped, garnet did not show any potential to cause dermal irritation or dermal corrosion.

Lutetium aluminium oxide, cerium doped, garnet did not show any potential to cause eye irritation or eye corrosion.

C&L is not required.