Dilanthanum tricarbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 Oct - 22 Dec 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

the treated area is ca. 4x4 cm (the guideline recommends ca. 6 cm²)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Remarks:

Swiss Federal Office of Public Health, 3003 Bern, Switzerland

Test material

Test material information

Constituent 1

Reference substance name:

Dilanthanum tricarbonate

EC Number:

209-599-5

EC Name:

Dilanthanum tricarbonate

Cas Number:

587-26-8

Molecular formula:

La2(CO3)3

IUPAC Name:

dilanthanum tricarbonate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 11-12 weeks (1 males), 12-14 weeks (2 females)
- Weight at study initiation: 2048 to 2494 g
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance, ad libitum
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period: 5 - 6 days


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

IN-LIFE DATES: From: 31 Oct 2005 To: 07 Nov 2005

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): undiluted
- Concentration (if solution): 0.5 g as such moistened with 0.5 mL of purified water (pH of a 1% solution: 5)

Duration of treatment / exposure:

4 hours

Observation period:

72-96 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 4x4 cm
- Type of wrap if used: The dressing was wrapped around the abdomen and anchored with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 1 animal was treated with three patches, applied sequentially. The first patch was removed after three minutes, the second after 1 hour and the third after 4 hours. The other two animals were treated for an exposure period of 4 h only.

SCORING SYSTEM: according to the numerical scoring system listed in the Commission Directive 2004/73/EC

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Any other information on results incl. tables

Skin irritation scores after 3 min exposure (1 animal):

No signs of erythema or edema (scores 0) were observed immediately after removal of the dressing up to 96 h.

Skin irritation scores after 1 h exposure (1 animal):

No signs of erythema (scores 0) were observed immediately after removal of the dressing, after 1 h very slight erythema (score 1) occured, this was reversible after 24 h, no further signs of erythema were observed up to 96 h. No signs of edema (score 0) was observed during the observation period.

Skin irritation scores after 4 h (3 animals)

Very slight erythema was observed in one animal at the 1 hour reading after the 4 hour exposure procedure. The individual mean score at the 24, 48 and 72 hour readings for erythema/eschar and oedema for each of the three animals was 0.

The body weights of all rabbits were considered to be within the normal range of variability.

Skin irritation scores – individual values (4 hour exposure)

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60-min	0 / 1 / 0	0 / 0 / 0
24 h	0 / 0 / 0	0 / 0 / 0
48 h	0 / 0 / 0	0 / 0 / 0
72 h	0 / 0 / 0	0 / 0 / 0
96 h	- / 0 / -	- / 0 / -
Average 24h, 48h, 72h	0 / 0 / 0	0 / 0 / 0

Examinations were performed at the specified times after removal of the dressing

At 96 h, no observations were performed on 1 male and 1 female animals.

Therefore, Lanthanum carbonate is not a skin irritant under the test conditions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information