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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.

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 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period limited to 7 days instead of 21 days
GLP compliance:
no

Test material

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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 - 3 kg

Test system

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"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 7 days
Score:
91.75
Max. score:
110
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Without washing
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:
other: Individual mean scores: 2.67, 2, 2, 2.67
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:
other: Individual mean scores: 1, 1, 1, 1
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:
other: Individual mean scores: 2.7, 2.7, 2.3, 2.3
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:
other: Individual mean scores: 4, 4, 4, 4
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.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
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.