Yttrium borate phosphate vanadate, europium-doped

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 16, 2010 - November 20, 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has been performed in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(1998)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): L579
- Substance type: white powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 16 - 17 weeks
- Weight at study initiation: 3.2-3.6 kg
- Housing: individually in ABS - plastic rabbit cages
- Diet: ad libitum (autoclaved hay and Altromin 2123 maintenance diet)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: approx. 26 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper

Vehicle:

other: the substance was moistened with aqua ad injectionem

Controls:

other: the untreated right side of the dorsal area served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Vehicle: aqua ad injectionem (Delta Select, lot no. 05007A, expiry date: June 2013)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 females (1 female subsequently followed by 2 females)

Details on study design:

TEST SITE
The test item was applied to a gauze patch and was moistened with aqua ad injectionem.
The patch was then applied to the skin on a small area (approx. 6 cm^2) on the left side of the dorsal area.
The gauze was held in place with non-irritating tape. The patch was fixed with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, using tap water
- Time after start of exposure: 4 hours

OBSERVATIONS
- Clinical signs: approximately 1, 24, 48 and 72 hours after patch removal
- Body Weight: at the start of the study and 72 hours after patch removal
- Irritation: the skin reactions were assessed at approximately 1, 24, 48 and 72 hours after patch removal. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM
The irritation was assessed according to the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: Mean value of score at 24, 48 and 72h after patch removal

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Individual scores: 0.66-0-0

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(of all 3 animals)

Time point:

other: Mean value of score at 24, 48 and 72h after patch removal

Score:

0

Max. score:

4

Remarks on result:

other: Individual scores: 0-0-0

Irritant / corrosive response data:

See section "Any other information on results incl. tables"

Other effects:

- No significant clinical signs of toxicity were observed
- No mortalities were observed
- No significant body weight changes were observed

Any other information on results incl. tables

Animal No.		Irritation (hours after patch removal)
		1 hour	24 hours	48 hours	72 hours
1	Erythema	1	1	1	0
	Oedema	0	0	0	0
2	Erythema	0	0	0	0
	Oedema	0	0	0	0
3	Erythema	1	0	0	0
	Oedema	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on a skin irritation study with rabbits, performed in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles, the substance does not need to be classified for skin irritation.

Executive summary:

In an in vivo skin irritation study in rabbits, conducted in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles, 3 female rabbits were semi-occlusively exposed for 4 hours to 0.5 g of the (moistened) substance. In 2 animals slight redness was observed, which reversed within 24 or within 72 hours. No significant clinical signs of toxicity nor mortalities were observed. Based on the result of this study, the substance does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.