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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Diniobium pentoxide 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:
25 July 2000 - 18 December 2000
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: Harlan UK Ltd., Bicester, Oxon, England.
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.4 – 2.8 kg

Housing:
- Diet (e.g. ad libitum): standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 12 days
- Sex: males

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light):12/12
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with electrical clipper
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with water ad injectionem
VEHICLE
- Aqua ad injectionem
Duration of treatment / exposure:
4 h
Observation period:
72 hours after patch removal
Number of animals:
3
Details on study design:
Approximately 0.5g of the test substance was applied under a 2-ply 25mm x 25mm gauze pad, which had been moistened with 0.5ml distilled water, to one intact skin on each animal.
Each treatment site was covered with “Eletroplast” elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (36°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.

SCORING SYSTEM: according to OECD 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
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 are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
Not irritating
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:
2000-07-24 to 2001-06-2001
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: Harlan UK Ltd., Bicester, Oxon, England
- Age at study initiation: 11 weeks
- Weight at study initiation: 2.3 to 3.0kg
- Housing: metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet)
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eyes of the animals served as control
Amount / concentration applied:
100mg
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
Eyes were evaluated at 1, 24, 48 and 72 hours after instillation
Irritation parameter:
cornea opacity score
Remarks:
- Corneal opacity
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Remarks:
- Iridal lesions
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
- Conjuctival redness
Basis:
mean
Remarks:
(mean of three animals and of three timepoints)
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Rabbit no. & sex Region of eye 1h 24h 48h 72h
1391 Male Cornea Density 0 0 0 0
Area 0 0 0 0
Iris 0 0 0 0
Conjuctiva Redness 2 1 0 0
Chemosis 1 0 0 0
1460 Male Cornea Density 0 0 0 0
Area 0 0 0 0
Iris 0 0 0 0
Conjuctiva Redness 1 1 1 0
Chemosis 1 0 0 0
1461 Male Cornea Density 0 0 0 0
Area 0 0 0 0
Iris 0 0 0 0
Conjuctiva Redness 1 0 0 0
Chemosis 0 0 0 0
Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
Not irritating to the eyes according to EU and GHS
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Diniobium pentaoxide was not corrosive to a human skin model in vitro. Subsequent in vivo testing in rabbits demonstrated that the substance is also not irritating to skin. Diniobium pentaoxide 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 available data for skin and eye irritation do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification of the registered substance.