Neodymium trinitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

11 March 1980 - 14 March 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Non-GLP study performed with a mixture of lanthanum trinitrate (75%) and neodymium trinitrate (25%), containing the following relevant methodological deficiencies: limited information on test conditions and test animals, no scoring at 1 and 48h, no 14 day observation period, occlusive wrap instead of semi-occlusive wrap used, 24h of exposure instead of 4 hours, conclusion was based on the observations made on intact skin but also abraded skin.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no scoring at 1 and 48 hours; 24 hours of exposure instead of 4 hours; occlusive wrap instead of semi-occlusive; also abraded skin exposed; no 14 day observation period

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Mixture of 75% lanthanum nitrate and 25% neodymium nitrate

IUPAC Name:

Mixture of 75% lanthanum nitrate and 25% neodymium nitrate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved; then intact or abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period:

25 hours and 72 hours after application of the test substance

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: trunk of the animals
- % coverage: no percentage specified, however small disks were applied of 3 cm diameter (aluminium disks covered with gauze)
- Type of wrap if used: adhesive bandage covering the trunk of the animal

REMOVAL OF TEST SUBSTANCE
- The discs were removed after 24 hours of exposure

SCORING SYSTEM:
Oedema and erythema were scored. The study protocol was based on the Draize or patch-test technique.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 25hr and 72 hr

Score:

1.31

Max. score:

12

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: mean calculated on observations of abraded and intact skin zones

Irritant / corrosive response data:

Erythema scoring of abraded zones: the skin was grey at the abraded place
Erythema scores at 25h (intact skin): 0, 0, 0, 2 (respectively)
Erythema scores at 72h (intact skin): 0, 0, 0, 2 (respectively)
Edema scores at 25h (intact skin): 0, 0, 0, 1 (respectively)
Edema scores at 72h (intact skin): 0, 0, 0, 0 (respectively)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the scoring system used (mean value of the observations in intact skin as well as abraded skin), the product existing of 75% lanthanum nitrate and 25% neodymium nitrate is classified as a mild primary skin irritant when applied as received. Based on the criteria of the CLP Regulation, the mixture would not be classified as a skin irritant, assuming that the effects are reversible within 14 days and are not increased after 72h.