Samarium

Endpoint summary

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

Reference

Reference 1

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.

Reference 2

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.

Reference 3

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

Reference

Reference 1

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.

Reference 2

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.

Reference 3

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.