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Diss Factsheets

Administrative data

Description of key information

The parent compound Vanadium-tris-acetylacetonate is rapidly hydrolysed to 2,4 -pentanedione (CAS no. 123 -54- 6) and Vanadyl acetylacetonate (CAS no. 3153 -26 -2) in the presence of water or moisture (> 80% hydrolysis after 1h at pH 1.2, 4, 7 and 9). Hence, the half life is < 1 h under neutral and acidic conditions. Accordingly, reliable data of the hydrolysis products 2,4-Pentadione (Cas no. 123-54-6) and Vanadyl acetylacetonate (3153-26-2) or comparable inorganic Vanadium compounds are used to address the endpoint, which is entirely appropriate to draw conclusions on the potential of Vanadium-tris-acetylacetonate to cause irritation or corrosion to the skin or eyes of mammals.

skin irritation

Acetylacetonate, rabbit, 0.5 mL (undiluted), 4 h, occlusive, 14 d (OECD TG 404): mild skin irritating

eye irritation

Acetylacetonate, rabbit, 0.1 mL (undiluted), 4 h, occlusive, 7 d (OECD TG 405): mild eye irritating

V2O5 microparticles, estimated 0.5 mg/m3 air, human: eye irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
please refer to Read-across statement attached in section 13
Reason / purpose for cross-reference:
read-across source
Remarks on result:
probability of mild irritation
Remarks:
see section "any other information on results incl. tables"
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Erythema:

- very slight local erythema in 5 of 6 rabbits on removal of the occlusive dressing (corresp. to score 1)

- very slight local erythema in 6 of 6 rabbits after 24 h (corresp. to score 1)

Edema:

- slight in 5 of 6 rabbits (corresp. to score 2)

- moderate in 1 of 6 rabbits (corresp. to score 3)

Reversibility:

- after 3 days, half the animals had just detectable erythema, one animal had mild edema

- after 7 days, mild desquamation (no other effects were seen)

Table 2. Scores for erythema and edema for various epicutaneous dosages o f 2.4-PD

Inspection Day

244 mg/kg

975mg/kg

1463mg/kg

 Males

Females

Males

Females

Males

Females

ERYTHEMA

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0.2(0-1)

0

0

0

4

0

0

0

0.3(0-1)

0.3(0-1)

0.5 (0-1)

5

0

0

0.6(0-2)

1.3(1-2)

2.0(All2)

1.7 (1-2)

6

0

0.3 (0-1)

1.0(0-2)

1.3(1-2)

1.8 (1-2)

1.7 (1-2)

7

0

0.3 (0-1)

1.0(0-2)

1.3 (1-2)

1.8 (1-2)

1.7 (1-1)

8

0.5(0-1)

0.5 (0-1)

1.4(1-2)

1.7 (1-2)

1.5 (1-2)

2.0(All2)

9

0.5(0-1)

1.0(All1)

1.8(1-2)

1.7 (1-2)

1.3 (1-2)

2.0(All2)

10

0.5(0-1 )

1.0(All1)

1.4(0-2)

1.3 (1-2)

1.3 (1-2)

1.0(AII1)

11

0.2(0-1)

1.0(All1)

1.0(0-2)

1.0(All 1)

1.3(1-2)

1.0(All1)

12

0.3 (0-1 )

1.0(All1)

0.8(0-2)

1.0(AII1)

1.3 (1-2)

1.0(All1)

EDEMA

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0.3(0-1)

4

0

0

0

0.3(0-1)

0.5(0-1)

0.6(0-1)

5

0

0

1.2 (0-2)

1.0(All1)

1.8 (1-2)

1.7 (1-2)

6

0

0

1.2(0-2)

1.0 (AII1)

1.5(1-2)

1.7 (1-2)

7

0

0

1.2 (0-2)

1.0(AII1)

1.5(1-2)

1.7 (1-3)

8

0.5 (0-2)

0.3 (0-1)

1.8(1-3)

1.3 (1-2)

2.5 ( 2 3)

2.0(All2)

9

0.7 (0-2)

0.5 (0-1)

2.0(1-3)

1.3 (1-2)

2-5(2-3)

2.0(All2)

10

0.7 (0-2)

0.8(0-1)

2.0(1-3)

1.3(1-2)

2-5 (2-3)

2.0(All2)

11

0.8 (0-2)

1.0 (0-2)

1.8(1-3)

1.3 (1-2)

2.5 (2 -3)

2.0(All 2)

12

1.0(0 -2)

1.2 (0-2)

1.6(1-3)

1.3 (1-2)

2.5 (2-3)

2.0(All2)

a No effects seen in control (water) group,

b Scored as: 0 = no effect, 1 = barely perceptible, 2 = well defined, 3 = moderate, 4 = severe

Interpretation of results:
GHS criteria not met
Conclusions:
Exposure to the test substance acetylacetonate caused very slight local erythema and mild or moderate edema in all 6 animals. Effects were reversible apart from desquamation visible after 7 days. Therefore, this study indicates a mild skin irritating potential of acetylacetonate. This result is also valid for the target substance vanadium-tris-acetylacetonate, since the source substance acetylacetonate is a hydrolysis product of vanadium-tris-acetylacetonate.
Executive summary:

The primary dermal irritation potential of acetylacetonate was evaluated in this study with New Zealand White rabbits similar to OECD Guideline 404. There was one group of six albino rabbits that received a single, 4 hour, occluded exposure. Each 0.5 mL dose of the acetylacetonate test article was applied to the clipped dorsal skin. At completion of exposure, the bandages were removed and the excess test item removed gently. Application sites were evaluated in accordance with the method of Draize at 1 , 24, 48 and 72 hours, 7 and 14 days after patch removal. Very slight local erythema and mild or moderate edema were noted for all animals. Effects were reversible apart from desquamation visible after 7 days. Therefore, this study indicates a mild skin irritating potential of acetylacetonate. However, the observed erythema and edema scores do not meet the requirements for classification as laid down in Regulation (EC) No 1272/2008. This result is also valid for the target substance vanadium-tris-acetylacetonate, since the source substance acetylacetonate is a hydrolysis product of vanadium-tris-acetylacetonate.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
please refer to Read-across statement attached in section 13
Reason / purpose for cross-reference:
read-across source
GLP compliance:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Effects (scores see table below):

Conjunctivae: just detectable excess conjunctival redness in 5 of 6 animals at 1 h postinstallation

Chemosis: slight chemosis in 2 of 6 animals, moderate chemosis in 1 of 6 animals

Iritis: mild iritis in 2 of 6 animals, persisting up to 4 h

Scores for the various effects seen in rabbit eyes following the installation of 0.1 mL acetylacetonate into the inferior conjunctival sac of one eye of each of six rabbits (scored according to the system of Draize):

Time

Effect as average (and range)

 

Conjunctiva

Iris

 

Redness

Chemosis

Discharge

 

1 h

0.8 (0-1)

0.7 (0-2)

1.3 (0-2)

0.3 (0-1)

4 h

0.7 (0-1)

0.7 (0-2)

1.2 (0-2)

0.2 (0-1)

24 h

0.0

0.0

0.0

0.0

Reversibility: All eyes were healed by 24 h postinstallation. No evidence of corneal injury on macroscopic inspection or following the installation of 2% fluorescein.

Interpretation of results:
GHS criteria not met
Conclusions:
Mean scores at 1 and 4 hours for conjunctival redness and iritis were 0-1 in all animals. Mean scores at 1 and 4 hours for each animal for chemosis and discharge was 0-2 for all animals. Effects were fully reversible, as no effects were seen after 24 h.
Therefore, the acetylacetonate test substance is minimal irritating to rabbit eyes. This result is also valid for the target substance vanadium-tris-acetylacetonate, since the source substance acetylacetonate is a hydrolysis product of vanadium-tris-acetylacetonate.
Executive summary:

In this study, the eye irritation potential of the acetylacetonate test substance was evaluated similar to OECD Guideline 405. A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 mL of the test article instilled into the lower conjunctival sac of one eye. The eyelid was held closed for one second and released. Observations for eye irritation were made at 1, 4, and 24 hours following dosing and on days 2, 3, and 7.

Mean scores at 1 and 4 hours for conjunctival redness and iritis were 0-1 in all animals. Mean scores at 1 and 4 hours for each animal for chemosis and discharge was 0-2 for all animals. Effects were fully reversible, as no effects were seen after 24 h.

Therefore, the acetylacetonate test substance is minimal irritating to rabbit eyes, but it does not meet the criteria for classification as laid down in Regulation (EC) No 1272/2008.

This result is also valid for the target substance vanadium-tris-acetylacetonate, since the source substance acetylacetonate is a hydrolysis product of vanadium-tris-acetylacetonate.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
please refer to Read-across statement attached in section 13
Reason / purpose for cross-reference:
read-across source
Remarks on result:
positive indication of irritation
Remarks:
eye irritation (conjunctivitis) was observed in 16 of 18 exposed man
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested

Three of the men exposed most severely had the symptom of 'burning eyes' after the first day of exposure. Upon examination after three days a slight conjunctivitis was diagnosed in these three workers. After two weeks of exposure to vanadium pentoxide particles, conjunctivitis was observed in 16 of 18 workers.

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Vanadium pentoxide microparticles caused eye irritation in 16 of 18 workers acutely exposed to vanadium pentoxide microparticles.
Executive summary:

Eighteen workers became were exposed to high concentrations (estimated 0.5 mg/m3 air) vanadium pentoxide particles of small particle size (0.1 and 10 µm). Vanadium pentoxide microparticles caused eye irritation in 16 of 18 workers. This indicates that the vanadium compound formed as a hydrolysis product of the target substance vanadium-tris-acetylacetonate may be eye irritating.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

skin irritation

The primary dermal irritation potential of acetylacetonate was evaluated in a study with New Zealand White rabbits similar to OECD Guideline 404. There was one group of six albino rabbits that received a single, 4 hour, occluded exposure. Each 0.5 mL dose of the acetylacetonate test article was applied to the clipped dorsal skin. At completion of exposure, the bandages were removed and the excess test item removed gently. Application sites were evaluated in accordance with the method of Draize at 1, 24, 48 and 72 hours, 7 and 14 days after patch removal. Very slight local erythema and mild or moderate edema were noted for all animals. Effects were reversible apart from desquamation visible after 7 days. Therefore, this study indicates a mild skin irritating potential of acetylacetonate.

For the vanadium containing source substances this endpoint is waived based on acute dermal toxicity studies. Here, no toxic effects were observed for V2O5, V2O3 and NH4VO3 at a concentrations of 2500 mg/kg bw. This waiver is supported by a patch test study in humans. In this study 100 humans were patch tested with vanadium pentoxide at the concentrations 1, 2 and 10 %. No skin reactions were observed (Motolese 1993).

eye irritation

The eye irritation potential of the acetylacetonate test substance was evaluated in accordance with OECD Guideline 405. A group of six albino rabbits was used for the study. Each animal received a single, unwashed exposure of 0.1 mL of the test article instilled into the lower conjunctival sac of one eye. The eyelid was held closed for one second and released. Observations for eye irritation were made at 1, 4, and 24 hours following dosing and on days 2, 3, and 7. Mean scores at 1 and 4 hours for conjunctival redness and iritis were 0-1 in all animals. Mean scores at 1 and 4 hours for each animal for chemosis and discharge was 0-2 for all animals. Effects were fully reversible, as no effects were seen after 24 h. Therefore, the acetylacetonate test substance is minimal irritating to rabbit eyes (Ballantyne 1986).

For vanadium compounds human data from an accident are available: Eighteen workers were exposed to high concentrations (estimated 0.5 mg/m3 air) vanadium pentoxide particles of small particle size (0.1 and 10 µm). Vanadium pentoxide microparticles caused eye irritation in 16 of 18 workers (Zenz 1962), please refer also to section 7.10.3.

respiratory irritation

In several studies with vanadium pentaoxide on acute inhalation toxicity irritating effects on the respiratory tract were reported.

Rats were exposed to dust of vanadium pentoxide (V2O5, CAS 1314 -62 -1) for 4 hours (nose only). Animals died up to 8 days after the inhalative exposure. Histopathological examination of the lungs of the animals that received inhalative exposure revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia.

This finding is also supported by findings in humans from an accidenal exposure (Zenze, 1986). Eighteen workers became acutely ill following inhalation of high concentrations (estimated 0.5 mg/m3 air) vanadium pentoxide particles of small particle size (0.1 and 10 µm). The clinical signs were irritation of the upper and lower respiratory tract, nasopharyngitis, hacking cough, fine rales and wheezing, bronchospastic, eye irritation (conjunctivitis), clinical illness. The onset and severity of symptoms equated directly with the intensity of exposure. The symptoms due to a second exposure were of greater intensity than those following the first exposure. The detection of vanadum in the urine indicates systemic absorption of vanadium after the inhalatory exposure.

Justification for classification or non-classification

Based on the available data on the source substance vanadium pentoxide, the target substance vanadium-tris-acetylacetonate is classified as eye irritant (Category 2, H319) and irritant to the respiratoty tract (H335) in accordance with Regulation (EC) No 1272/2008. Regarding skin irritation, the observed erythema and edema scores in rabbits after 2,4 -pentanedione application do not meet the requirements for classification as laid down in Regulation (EC) No 1272/2008.