Aluminum magnesium vanadium oxide

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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:

5 - 15 Feb 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministère du redressement productif, Secrètariat general du GIPC DGCIS SI, Ivry-sur-Seine, France

Species:

rabbit

Strain:

other: albino New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome, Linxe, France
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.64-2.88 kg
- Housing: animals were housed individually in boxes.
- Diet: food (SAFE – 112), ad libitum
- Water: drinking water from the public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g moistened with water

Duration of treatment / exposure:

4 h

Observation period:

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

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on one flank of each animal
- Type of wrap if used: the patch was held in place with a strip of surgical adhesive tape under semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was rinsed with distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

other: 1 h reading time point: very slight erythema in 1 animal

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

other: 1 h reading time point: very slight edema in 1 animal

Irritant / corrosive response data:

One hour after patch removal, a very slight erythema associated with a very slight edema was noted on the treated area of one animal, which was fully reversible at the 24 h reading time point.

Other effects:

No further local or systemic effects were reported.

Interpretation of results:

GHS criteria not met

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:

07 - 20 Feb 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministère de l'Économie, des Finances et de l'Industrie, Secrétariat général du groupe interministériel des produits chimiques, DGCIS, Service de l'industrie, bureau de la chimie, Paris, France

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome, Linxe, France
- Age at study initiation: 12-13 weeks
- Weight at study initiation: 2.62-3.11 kg
- Housing: animals were housed individually in boxes.
- Diet: C15 diet (SDS), ad libitum
- Water: tap water from the public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 50-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye remained untreated and served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h (animals #1 and #3) and 7 days (animal #2)
Reading time points: 1, 24, 48 and 72 h as well as 7 days

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The ocular reactions observed during the study were slight to moderate and totally reversible in all three animals. Slight to moderate redness of the conjunctivae was noted in all animals already 1 h after test substance instillation. No effects on iris and cornea were observed, except for 1 animal which showed congestion 1 h after exposure. However, this effect was totally reversible on Day 1 of the observation period.

Other effects:

No further local or systemic effects were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The skin irritation potential of aluminium magnesium vanadium oxide was investigated in a GLP-conform study according to OECD guideline 404 (2013). The undiluted test substance (0.5 g), moistened with water, was applied for 4 h to the clipped skin of 3 female albino New Zealand White rabbits under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. One hour after patch removal, a very slight erythema associated with a very slight edema was noted on the treated area of one animal, which was fully reversible at the 24 h observation time point. No further skin reactions at the application site were noted in any animal at any of the other observation time points. No signs of systemic toxicity were reported. The mean erythema and edema scores after 24, 48 and 72 h were 0 for all 3 animals. Therefore, the test substance was not considered to be skin irritating.

Eye irritation

The eye irritation potential of aluminium magnesium vanadium oxide was studied according to OECD guideline 405 and in compliance with GLP (2012). The undiluted test substance (0.1 g) was instilled into the conjunctival sac of each one eye of 3 female New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance instillation. Slight to moderate redness of the conjunctivae was already noted in all animals 1 h after treatment with the test substance.This effect was fully reversible within 48 h, 72 h or 7 days after treatment. In two animals, slight to moderate chemosis was observed at 1 or 24 h reading, and was no longer evident 48 or 72 h after exposure to the test substance. No effects on iris and cornea were observed, except for 1 animal which showed congestion at the 1 h reading. However, this effect was totally reversible at the 24 h reading of the observation period. The individual mean scores for corneal opacity and iris light reflex after 24, 48 and 72 h were 0 for all three animals. The individual mean scores after 24, 48 and 72 h for the conjunctivae were 1.0, 1.3 and 0.7 for reddening, and 0.3, 1.0 and 0 for chemosis, respectively. Based on these results, the test substance was not considered to be an eye irritant.

Justification for classification or non-classification

The available data on skin and eye irritation of aluminium magnesium vanadium oxide do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.