Niobium

Endpoint summary

Description of key information

Niobium metal is not irritating to skin or eyes.

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:

2009-08-06 to 2009-11-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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, Sulzfeld, Germany
- Age at study initiation: approximately 15 weeks
- Weight at study initiation: > 2 kg
- Diet (ad libitum): ad libitum
- Water (ad libitum):ad libitum
- Acclimation period: 5 days
- Sex: females

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

IN-LIFE DATES: From: 2009-09-07 To: 2009-09-11

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped with electrical clipper

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g moistened with water ad injectionem


VEHICLE
Aqua ad injectionem
- Lot/batch no. (if required): 749A191

Duration of treatment / exposure:

4 h

Observation period:

Reading time points: 1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm² of the left dorsal trunk
- Type of wrap if used: gauze patch held in place with non-irritating tape

SCORING SYSTEM: according to OECD 404 (Draize scoring)

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

At all evaluation time points the individual scores for erythema and oedema were 0.

Other effects:

none

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified

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:

2009-08-31 to 2009-10-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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, Sulzfeld, Germany
- Age at study initiation: 23 weeks
- Weight at study initiation: > 2kg
- Housing: ABS plastic rabbit cages, floor 4200 cm2
- Diet (ad libitum): ad libitum
- Water ( ad libitum):ad libitum
- Acclimation period: 5 days

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

IN-LIFE DATES: From: 2009-09-14 To: 2009-09-18

Vehicle:

physiological saline

Controls:

other: untreated eyes of the animals served as control

Amount / concentration applied:

0.1 mL of test item extract

Duration of treatment / exposure:

single application

Observation period (in vivo):

Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3
treated in sequential manner (according to guideline)

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

mean of all 3 animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: grade 1 at 24 h scoring time point

Irritation parameter:

conjunctivae score

Basis:

other: animal # 1 and 2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification according to Regulation (EC) No 1272/2008

Conclusions:

Not irritating to the eyes according to EU and GHS
CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Niobium was not corrosive to a human skin model in vitro. Subsequent in-vivo testing in rabbits demonstrated that niobium is also not irritating to skin.

Niobium was not irritating in an in-vitro HETCAM assay and in an in-vivo test in the eyes of rabbits.

Justification for classification or non-classification

The criteria for classification as skin or eye irritant of CLP or DSD are not fulfilled.