Neodymium trinitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 3 December 2013 to 6 December 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

relative humidity was out (min 23%) of target range (30-70%) during the study; this deviation is not considered to have impact on the outcome of the study and the interpretation of the results

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

relative humidity was out (min. 23%) of target range (30-70%) during the study; this deviation is not considered to have impact on the outcome of the study and the interpretation of the results

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

yes

Remarks:

relative humidity was out (min. 23%) of target range (30-70%) during the study; this deviation is not considered to have impact on the outcome of the study and the interpretation of the results

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Neodymium trinitrate

EC Number:

233-153-9

EC Name:

Neodymium trinitrate

Cas Number:

10045-95-1

Molecular formula:

HNO3.1/3Nd

IUPAC Name:

neodymium trinitrate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft, 2173 Kartal, Csaszar ut 135, Hungary
- Age at study initiation: 16 weeks old
- Weight at study initiation: 3606-3825 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 42 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.3 - 21.1 °C
- Humidity (%): 23 - 70%
- Air changes (per hr): 15 - 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily light, from 6.00 a.m. to 6.00 p.m.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated skin of each animal served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The powdered test item was used in a single dose of 0.5 g applied to the test area.

Duration of treatment / exposure:

4 hours

Observation period:

Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal. The duration of the study was sufficient to evaluate the reversibility or irreversibility of the effects observed.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of intact skin, back and flanks of animals
- On the day of treatment, 0.5 g of the test item was placed on a surgical gauze pad (approximately 5 cm x 5 cm) and sufficient water was added to dampen the material to ensure good contact with the skin. This gauze pad was applied to the intact skin of the clipped area and was kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals was then wrapped with plastic wrap held in place with an elastic stocking.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The semi-occlusive dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.

SCORING SYSTEM: The dermal irritation scores were evaluated according to the scoring system by Draize (1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

4 hours exposure

Basis:

mean

Remarks:

(three animals)

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Remarks:

4 hours exposure

Basis:

mean

Remarks:

(three animals)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

edema score

Remarks:

4 hours exposure

Basis:

mean

Remarks:

(three animals)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

At observation 1, 24, 48 and 72 hours after patch removal, there were no observed irritancy signs noted on the skin of the treated animals. As no irritancy signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.

Other effects:

No mortality was observed during the study. There was no test item related effect on body weight. There were no test item related general clinical signs noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The irritant potential of neodymium trinitrate (hydrated form) to the skin was evaluated in three rabbits. The test item was considered not to be irritating.
Based on the results of this study, neodymium trinitrate does not require classification as skin irritant.