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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Skin Irritation

In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.

The smallest form of the substance that can be produced occurs as sharp needle-like flakes. Application to a surface is likely to result in physical damage to the surface. Any effects would relate to the physical state of the substance rather than be the result of chemical irritation from the substance itself.

It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.

Furthermore, an acute dermal toxicity study conducted with the read across substance, samarium oxide did not indicate skin irritation up to the limit dose level of 2 000 mg/kg bw. The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.

- Supporting information on the read-across substance, samarium oxide

Under the conditions of the study no signs of dermal irritation were noted. The Primary Dermal Irritation Index was 0. The test material was therefore concluded not to be a skin irritant.

Eye irritation

In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.

The smallest form of the substance that can be produced occurs as sharp needle-like flakes. Application to a surface is likely to result in physical damage to the surface. Any effects would relate to the physical state of the substance rather than be the result of chemical irritation from the substance itself.

It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.

The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.

- Supporting information on the read-across substance, samarium oxide

Samarium oxide was concluded to be minimally irritating to both the unwashed and washed eye under the conditions of the study.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
The smallest form of the substance that can be produced occurs as sharp needle-like flakes. Application to a surface is likely to result in physical damage to the surface. Any effects would relate to the physical state of the substance rather than be the result of chemical irritation from the substance itself.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.
Furthermore, an acute dermal toxicity study conducted with the read across substance, samarium oxide did not indicate skin irritation up to the limit dose level of 2 000 mg/kg bw.
Since the surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.5 g dose was applied to one intact and one abraded skin site (approx. 2.5 cm²) of six rabbits (New Zealand Albino) and occluded for 24 hours. The patches were then removed and the test sites wiped. The sites were evaluated 24 and 72 hours after initial exposure according to the method of Draize.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
other: one intact and one abraded skin site per animal
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
72 hours following test material application.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm²

REMOVAL OF TEST SUBSTANCE
The patches were removed 24 hours after test material application and the test sites wiped.

OBSERVATION TIME POINTS
The sites were evaluated 24 and 72 hours after initial exposure.

SCORING SYSTEM:
Sites were evaluated according to the method of Draize.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: not specified
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of dermal irritation.
Interpretation of results:
other: Not classified in accordance with EU criteria
Conclusions:
Under the conditions of the study no signs of dermal irritation were noted. The Primary Dermal Irritation Index was 0. The test material was therefore concluded not to be a skin irritant.
Executive summary:

The skin irritation potential of the test material, samarium oxide, was investigated.

During the study, a 0.5 g dose was applied to one intact and one abraded skin site (approx. 2.5 cm²) of six rabbits (New Zealand Albino) and occluded for 24 hours. The patches were then removed and the test sites wiped. The sites were evaluated 24 and 72 hours after initial exposure according to the method of Draize.

Under the conditions of the study no signs of dermal irritation were noted. The Primary Dermal Irritation Index was 0. The test material was therefore concluded not to be a skin irritant.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: not specified
Score:
0
Remarks on result:
no indication of irritation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.
The smallest form of the substance that can be produced occurs as sharp needle-like flakes. Application to a surface is likely to result in physical damage to the surface. Any effects would relate to the physical state of the substance rather than be the result of chemical irritation from the substance itself.
It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Justification for type of information:
The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Reason / purpose for cross-reference:
other: read-across target
Qualifier:
no guideline followed
Principles of method if other than guideline:
A 0.1 g dose was applied to the left eye of six rabbits (New Zealand Albino). Three of the treated eyes were rinsed with saline 30 seconds post-installation. Eyes were examined at 24, 48 and 72 hours by the method of Draize.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Observation period (in vivo):
Eyes were examined at 24, 48 and 72 hours.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
Three of the treated eyes were rinsed with saline 30 seconds post-installation.

SCORING SYSTEM:
Eyes were evaluated according to the method of Draize.
Irritation parameter:
other: Draize score
Remarks:
(unwashed eyes)
Basis:
mean
Time point:
24/48/72 h
Score:
2.4
Reversibility:
not specified
Irritation parameter:
other: Draize score
Remarks:
(washed eyes)
Basis:
mean
Time point:
24/48/72 h
Score:
3.1
Reversibility:
not specified

Draize scores:

- Unwashed (3 rabbit mean)       24h 5.3       48h 2.0       72h 0.0

- Washed (3 rabbit mean)           24h 5.3       48h 3.3       72h 0.7   

Interpretation of results:
study cannot be used for classification
Conclusions:
Samarium oxide was concluded to be minimally irritating to both the unwashed and washed eye under the conditions of the study.
Executive summary:

The eye irritation potential of the substance samarium oxide was evaluated.

During the study, a 0.1 g dose was applied to the left eye of six rabbits (New Zealand Albino). Three of the treated eyes were rinsed with saline 30 seconds post-installation. Eyes were examined at 24, 48 and 72 hours by the method of Draize.

The mean Draize scores of the three rabbits with unwashed treatment eyes were 5.3, 2.0 and 0.0 at 24, 48 and 72 hours, respectively.

The mean Draize scored of the three rabbits with washed treatment eyes were 5.3, 3.3 and 0.7 at 24, 48 and 72 hours, respectively.

Samarium oxide was concluded to be minimally irritating to both the unwashed and washed eye under the conditions of the study.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted on read-across material
Justification for type of information:
The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
other: Draize score
Remarks:
(unwashed eyes)
Basis:
mean
Time point:
24/48/72 h
Score:
2.4
Reversibility:
not specified
Irritation parameter:
other: Draize score
Remarks:
(washed eyes)
Basis:
mean
Time point:
24/48/72 h
Score:
3.1
Reversibility:
not specified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.

The smallest form of the substance that can be produced occurs as sharp needle-like flakes. Application to a surface is likely to result in physical damage to the surface. Any effects would relate to the physical state of the substance rather than be the result of chemical irritation from the substance itself.

It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.

Furthermore, an acute dermal toxicity study conducted with the read across substance, samarium oxide did not indicate skin irritation up to the limit dose level of 2 000 mg/kg bw.

Since the surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.

- Supporting information on the read-across substance, samarium oxide

The skin irritation potential of the test material, samarium oxide, was investigated.

During the study, a 0.5 g dose was applied to one intact and one abraded skin site (approx. 2.5 cm²) of six rabbits (New Zealand Albino) and occluded for 24 hours. The patches were then removed and the test sites wiped. The sites were evaluated 24 and 72 hours after initial exposure according to the method of Draize.

Under the conditions of the study no signs of dermal irritation were noted. The Primary Dermal Irritation Index was 0. The test material was therefore concluded not to be a skin irritant.

Eye Irritation

In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable.

The smallest form of the substance that can be produced occurs as sharp needle-like flakes. Application to a surface is likely to result in physical damage to the surface. Any effects would relate to the physical state of the substance rather than be the result of chemical irritation from the substance itself.

It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested.

The surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible.

- Supporting information on the read-across substance, samarium oxide

The eye irritation potential of the substance samarium oxide was evaluated.

During the study, a 0.1 g dose was applied to the left eye of six rabbits (New Zealand Albino). Three of the treated eyes were rinsed with saline 30 seconds post-installation. Eyes were examined at 24, 48 and 72 hours by the method of Draize.

The mean Draize scores of the three rabbits with unwashed treatment eyes were 5.3, 2.0 and 0.0 at 24, 48 and 72 hours, respectively.

The mean Draize scored of the three rabbits with washed treatment eyes were 5.3, 3.3 and 0.7 at 24, 48 and 72 hours, respectively.

Samarium oxide was concluded to be minimally irritating to both the unwashed and washed eye under the conditions of the study.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin or eye irritation or corrosion.