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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Acute toxicity - oral:
A K2 acute oral toxicity test was performed in female Sprague-Dawley rats according to a guideline similar to OECD Guideline 401 (Bruce DW, 1963). This study was selected as key study.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Sufficiently documented acute oral toxicity study in female rats performed according to a method equivalent to OECD Guideline 401.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: adult
- Weight at study initiation: 190 g to 250 g
- Fasting period before study: no data
- Housing: Animals were housed in air-conditioned quarters
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
50% aqueous solution
Doses:
unknown
No. of animals per sex per dose:
5 or 10 animals per group

Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 30 days
Statistics:
On the basis of the mortality that occurred during the 30-day observation period, the LD50 values with 95% confidence limits were calculated by the method of Litchfield and Wilcoxon (1949).
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 500 mg/kg bw
Based on:
test mat.
95% CL:
3 017 - 4 060
Mortality:
The animals were observed for 30 days although no deaths occurred later than 4 days after administration of the nitrate salts by the oral route.
Clinical signs:
other: Within 1 to 2 hours after oral administration of the rare earth nitrates most of the rats were depressed, and animals that received lethal doses showed little activity during the survival period.
Gross pathology:
Throughout the observation period no gross pathologic changes were noted.


Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of praseodymium nitrate in female rats was determined to be 3500 mg/kg. The test substance is considered not classified according to the criteria of the CLP Regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: oral

Bruce DW (1963) investigated the acute oral toxicity via gavage of a single oral dose of praseodymium nitrate in 5 to 10 female Sprague-Dawley rats. The animals were observed for 30 days although no deaths occurred later than 4 days after administration. Within 1 to 2 hours after oral administration of the rare earth nitrates most of the rats were depressed, and animals that received lethal doses showed little activity during the survival period. Throughout the observation period no gross pathologic changes were noted. The acute oral LD50 of praseodymium nitrate in female rats was determined to be 3500 mg/kg.

No data were available for the inhalation and dermal route.

Justification for classification or non-classification

Based on the results of the acute oral toxicity study and according to the criteria of the CLP Regulation, praseodymium trinitrate should not be classified as an acute oral toxicant.

No data were available to decide on the classification for the inhalation and dermal route.