Praseodymium trinitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1980-07-29 - 1980-07-31

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

GLP study with relevant methodological deficiencies: scoring limited to 24 and 48h, no details on scoring system (presumably limited to corrosive yes/no). No conclusion can be drawn on the irritating potential of the mixture or the substances in the mixture.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no details on test animals and conditions, observations limited to 24h and 48h after exposure, no details on scoring system

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: procedure specified in Title 49, CFR articles 173.240, Appendix A

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Solution of 70% Praseodymium and 30% Neodymium

IUPAC Name:

Solution of 70% Praseodymium and 30% Neodymium

Specific details on test material used for the study:

- Batch number: 10238-2

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Margaret's Home Farm Athol, Massachusetts
- Age at study initiation: no data
- Weight at study initiation: range: 2.0 - 2.5 kg

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Patches were removed after 4 hours and scored for destruction or irreversible alteration of the skin. The test sites were again observed at 24 and 48 hours.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: animal's right side at two sites, covered with cotton gauze and secured with tape.

REMOVAL OF TEST SUBSTANCE
Patches were removed after 4 hours and scored for destruction or irreversible alteration of the skin. The test sites were again observed at 24 and 48 hours.

SCORING SYSTEM:
If the test substance corrodes the skin of two or more rabbits, the sample is considered corrosive (Title 49 CFR 173.240)

Results and discussion

In vivo

Results

Irritation parameter:

other: corrosivity

Basis:

other: all animals

Time point:

other: 24 and 48h

Score:

0

Reversibility:

no data

Irritant / corrosive response data:

Based on the standards set by Title 49 CFR 173.240, the solution of Praseodymium 70%, Neodymium 30% does not cause skin corrosion.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Due to the lack of a scoring system, the conclusion cannot be firmly validated and confirmed on the skin irritation/corrosion potential of the mixture or its constituents.