Dodecaaluminium trimolybdenum dodecaoxide

Endpoint summary

Description of key information

Skin irritation: not irritating
Eye irritation: 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:

14 - 28 May 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:

Secrétariat général du GIPC - DGCIS - SI -BP 80001 - 67 rue Barbès - F-94201 IVRY-SUR-SEINE

Species:

rabbit

Strain:

other: albino New Zealand

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 11 weeks old
- Weight at study initiation: between 2.25 kg and 2.65 kg
- Housing: in individual boxes
- Diet (e.g. ad libitum): SAFE - 112; ad libitum
- Water: tap-water (from public distribution system - microbiological and chemical analyses of the water were carried out once every six months); ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 13
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: on the opposite flank an untreated area served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours (as no tissue destruction was noted after a treatment during 3 minutes and 1 hour)

Observation period:

7 days: skin reactions were evaluated 1 hour and then 24, 48 and 72 hours and 7 days after removal of the patch

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: back and flank
- % coverage: 6 cm²
- Type of wrap if used: strip of surgical adhesive tape under semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with distilled water after the removal of the patch
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Very slight erythema and edema (score = 1) were noted in all animals 1 h after removal of the patch. In 2 of 3 animals, erythemas were fully reversible within 48 hours. The third animal showed no erythema on day 7. Edemas were fully reversible within 24 hours.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Secrétariat général du groupe interministeriel des produits chimiques (GIPC), 67 rue Barbès, F-94201 Ivry-sur-seine

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labste - F40260 Linxe)
- Age at study initiation: 11 or 13 weeks old
- Weight at study initiation: between 2.04 and 3.04 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned rooms.
- Diet: SAFE - 112; ad libitium
- Water: tap-water from 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

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days (for animal A2800); 72 h (for animals A2839 and A2840)
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes were rinsed with physiological saline (solid test substance has not been removed from the eyes of the test animals by physiological mechanisms at the first observation time point of 1 hour after instillation)
- Time after start of exposure: 1 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.6

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

1 h after test item instillation, all animals showed effects on the conjunctivae (redness: score 1 -2; chemosis: score 1). Conjunctival redness was fully reversible within 24 h for animal no. A2839, within 72 h for animal no. A2840 and within 7 days for animal no. A2800, respectively. Chemosis was fully reversible within 24 h for animal no. A2839, within 48 h for animal no. A2840 and within 72 h for animal no. A2800, respectively.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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 study was performed in accordance with OECD 404 (Colas, 2013). The undiluted test substance was applied to the intact skin of rabbits and covered with a gauze patch. Under semi-occlusive conditions, the gauze patch was held in place with an adhesive tape for 4 h. Thereafter, the gauze patch was removed and the treated skin site was cleaned with distilled water. Evaluation of the treated skin sites was done 1, 24, 48, 72 h and 7 d after patch removal. Very slight erythema and edema (score = 1) were noted in all animals 1 h after removal of the patch. In 2 of 3 animals, erythemas were fully reversible within 48 hours. The third animal showed no erythema on day 7. Edemas were fully reversible within 24 hours. Under the conditions of the test, aluminium molybdenum oxide showed skin irritation scores but well below the threshold for classification with respect to skin irritation.

Eye irritation

The potential of aluminium molybdenum oxide to cause ocular corrosivity or severe irritancy was evaluated in the HET-CAM test following ICCVAM HET-CAM Method Protocol, Nov. 2006 (ICCVAM Test Method Evaluation Report: Appendix G) (Andres, 2011).

Freshly laid Lohmann Leghorn chicken eggs were incubated at 38.5 °C and 58 - 59.7% humidity in a still air incubator for eight days. Only eggs with a weight of 50 – 60 g were used for the test. The test item was given directly onto the CAM (Chorion-Allantois-Membrane) surface of 6 eggs. 300 µL of the test item was given on the membrane and the reaction of the CAM was observed over a period of 300 seconds. The time for the appearance of the following endpoints (as described in the guideline) were recorded: haemorrhage, vascular lysis, and coagulation. The following evaluation criteria for the calculated irritation score (IS) were applied: IS = 0 - 0.9: not irritant, IS = 1 - 4.9: slightly irritant, IS = 5 - 8.9: moderately irritant, and IS = 9 - 21: severely irritant. The mean IS for the test substance was 0.00 (negative control: 0.00; positive controls: 19.95 (NaOH) and 11.05 (SDS)). Thus, based on the result of this HET-CAM test, the test substance is considered to be not corrosive. However, no conclusion on eye irritation potential can be drawn as the test can only distinguish between corrosive and not corrosive.

According to OECD 405, the test substance was placed into the conjunctival sac of the right eye of each rabbit (Colas, 2013). The left eye remained untreated and was used for control. 1, 24, 48, 72 h and 7 days after test substance instillation, the grades of ocular reaction (conjunctivae redness, conjunctivae chemosis, cornea, iris) were assessed. The treated eyes were rinsed with physiological saline at 1 h after instillation, as the solid test substance has not been removed from the eyes by physiological mechanisms at the first observation time point. At 1 h post application, conjunctival redness and chemosis (score 1-2) were noted in all animals. However, the effects were fully reversible within 72 h for chemosis and within 7 days for redness. No effects on iris or cornea were observed during the study period. Under the conditions of the test, the test substance caused eye irritation, but well-below the threshold for classification.

Therefore, the test substance is not considered as irritating to the eyes.

 

Justification for classification or non-classification

The available data on skin and eye irritation of aluminium molybdenum oxide do not meet the criteria for classification according to Regulation (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD), and are therefore conclusive but not sufficient for classification.