Lanthanum trinitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 March 2013 - 2 April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented GLP study performed according to OECD guideline 404 and EU Method B4.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lanthanum trinitrate

EC Number:

233-238-0

EC Name:

Lanthanum trinitrate

Cas Number:

10099-59-9

Molecular formula:

H3LaN3O9+3

IUPAC Name:

lanthanum trinitrate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.20-2.30 kg
- Housing: suspended cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12h light (6-18h); 12h dark (18-6h)

IN-LIFE DATES: From: 5 March 2013 To: 2 April 2013

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: not needed

Amount / concentration applied:

TEST MATERIAL
- for the purpose of the study, the test item was ground to a powder prior to application.
- 0.5g of the test item was used as supplied, moistened sifficiently with 0.5 mL of distilled water to achieve a paste.

Duration of treatment / exposure:

1st animal: 3 minutes, 1 hour, 4 hours
2nd animal: 4 hours

Observation period:

immediately after removal and approximately 1h , 24h, 48h, 72 h later and 7 days after exposure.

Number of animals:

2 males

Details on study design:

TEST SITE
- Area of exposure: 3 suitable sites on the back of the rabbit
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch, secured with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: immediately

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Remarks:

3 min exposure

Basis:

animal #1

Time point:

other: immediately, 1h, 24h, 48h, 72h and 7 days

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

erythema score

Remarks:

1 hour exposure

Basis:

animal #1

Time point:

other: immediately, 1h, 24h, 48h, 72h and 7 days

Score:

0 - 1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: slight desquamation is observed

Results 3

Irritation parameter:

edema score

Remarks:

1 hour exposure

Basis:

animal #1

Time point:

other: immediately, 1h, 24h, 48h, 72h and 7 days

Score:

0 - 1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

4 hours exposure

Basis:

mean

Remarks:

2 animals

Time point:

other: immediately, 1h, 24h, 48h, 72h, 7d, 14d

Score:

1.8

Max. score:

8

Reversibility:

fully reversible

Irritant / corrosive response data:

3-Minute semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.

1-Hour semi-occluded applications of the test item to the intact skin of one rabbit produced very slight edema at the treated skin site at the 24-Hour observation. Very slight erythema was noted at the treated skin site at the 48 and 72-Hour observations. Slight desquamation was noted at the treated skin site at the 7-Day observation.

A single 4-Hour semi-occluded application of the test item to the intact skin of one rabbit produced well-defined erythema at one treated skin site immediately and one hour after patch removal. Well-defined erythema was noted at one treated skin site and very slight erythema was noted at the other treated skin site at the 24 and 48-Hour observations with very slight erythema noted at both treated skin sites at the 72-Hour observation.

Very slight edema was noted at one treated skin site immediately and one hour after patch removal and at both treated skins site at the 24-Hour observation.

Slight desquamation was noted at one treated skin site and moderate desquamation was noted at the other treated skin site at the 7-Day observation.

Other effects:

Both animals showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produced a primary irritation index of 1.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test item does not meet the criteria for classification according toRegulation (EC) No 1272/2008, relating to the Classification, Labeling and Packaging of Substances and Mixtures.