Neodymium trinitrate

Endpoint summary

Description of key information

Based on the criteria as specified in the test report, the product existing of 75% lanthanum nitrate and 25% neodymium nitrate is classified as extremely irritating. Based on the criteria of the CLP Regulation, the substance is classified as Eye Dam 1 H318 based on the severe effects that have been observed. Reversibility is not expected.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-06-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Principles of method if other than guideline:

Electrochemic determination of pH
Determination of the acidic reserve via titration

GLP compliance:

yes

Species:

other: not applicable

Strain:

other: Not applicable

Details on test animals or test system and environmental conditions:

Not applicable

Type of coverage:

other: Not applicable

Preparation of test site:

other: Not applicable

Vehicle:

not specified

Details on study design:

Purpose:
The higher the buffer capacity of a mixture (solution or slurry) is, the stronger the irritating and corrosive potential is, respectively. The physiological effects of acidic or alkaline solutions are not only determined by the pH value but also by the buffering capacity. That is why it is necessary to determine the alkaline or acid reserve of identified products.

Method:
First, the pH-value of a 10% solution (or slurry) is determined electrochemically at 20°C with a calibrated pH meter (MA 235 Mettler Toledo). This value is recorded.

Determination of the acidic reserve titration:
- For the determination of the acid reserve: the titration volume (in mL) of a 1 mol/L NaOH solution, which is required to achieve a pH of 4 of a 10% solution (or slurry) at 20°C, is recorded.

Calculations:
Titration of the 10% solution/slurry
Acid reserve = titration volume [mL] x 0.4

A product is classified as corrosive if:
pH - 1/12 acid reserve <= -0.5

Irritation / corrosion parameter:

other: pH and acidic reserve

Run / experiment:

1

Value:

2.051

Vehicle controls validity:

not examined

Negative controls validity:

not examined

Positive controls validity:

not examined

Remarks on result:

no indication of irritation

A pH value of 2.07 was determined.

Interpretation of results:

GHS criteria not met

Conclusions:

The pH value of 10% solution of neodymium trinitrate was determined to be 2.07 and the acidic reserve 0.224. Based on these data, the calculation for corrosivity was 2.051 (> -0.5). Therefore the substance was considered not to be corrosive.

Not corrosive (based on an acidic reserve of and pH of 2.07, the calculation for corrosivity was 2.051 which is higher than -0.5)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

10 March until 15 March 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study performed with a mixture of lanthanum trinitrate (75%) and neodymium trinitrate (25%), containing the following deviations: observation period limited to 7 days, limited details on test animals and conditions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

observation period limited to 7 days instead of 21 days

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 - 3 kg

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

0.1 g of the product was instilled in the conjunctival sac of the left eye.

Observation period (in vivo):

1 hour and 1, 2, 3, 4 and 7 days after instillation.

Number of animals or in vitro replicates:

4

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): scoring was done if no washing done and if washing was done after 30 seconds. As the guideline prescribes a wash-out only after at least 24h, the scores of the eyes that were washed after 30s are not taken into account for the purpose of REACH.


SCORING SYSTEM: Draize scoring system, Kay and Calandra (1962) J. Soc. Cosmet. Chem. 13, 281: "Interpretation of eye-irritation tests"

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

7 d

Score:

91.75

Max. score:

110

Reversibility:

not fully reversible within: 7 days

Remarks on result:

probability of severe irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

probability of severe irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

probability of severe irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

probability of severe irritation

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

Based on the scoring of Draize and Kay and Calandra, the substance was judged to be extremely irritating.
Other effects: iris scores increasing from 1 to 2 after 7 days in 3 of 4 animals and no pupil reflex; reduced pupil reflex from day 3 onwards; myosis after 1 h in 1 animal and after day 1 in all animals.

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the criteria as specified in the test report, the product existing of 75% lanthanum nitrate and 25% neodymium nitrate is classified as extremely irritating. Based on the criteria of the CLP Regulation, the substance is classified as Eye Dam 1 H318 based on the severe effects that have been observed. Reversibility is not expected.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the criteria as specified in the test report, the product existing of 75% lanthanum nitrate and 25% neodymium nitrate is classified as extremely irritating. Based on the criteria of the CLP Regulation, the substance is classified as Eye Dam 1 H318 based on the severe effects that have been observed. Reversibility is not expected.