Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guidelines of the Department of Transportation (D.O.T.), Code of Federal Regulations, Title 49, Part 173
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Rare Earth Solution Code #1455
- Molecular formula (if other than submission substance): LaCl3*3(H2O)
- Physical state: amber liquid
- Concentration of solution: 100%
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms Inc.
- Weight at study initiation: 100 - 150 g
- Fasting period before study: overnight
- Housing: 5 per wire mesh suspended cage
- Diet (Purina Laboratory Chow) and water ad libitum
- Acclimation period: 7 d

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.9 mL

RANGE FINDING STUDY
- Concentrations tested: 3980, 6320, and 10000 mg/kg
- 2 animals per concentration
- result: No. dead/No. dosed: 10000 mg/kg: 2/2; 6320 mg/kg: 2/2; 3980 mg/kg: 1/2
Doses:
2820, 3550 and 4470 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 48 hours
- Frequency of observations and weighing: clinical signs were noted immediately after dosing and at 4, 24, and 48 hours; body weights were recorded at dosing and at 48 hours for the survivors.
- Animals found dead or terminated after 48 hours were subjected to a macroscopic examination of the viscera.
Statistics:
LD50 was calculated according to the method of: Litchfield and Wilcoxon, Pharmacol. and Exp. Ther. 96(99): 1499

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 200 mg/kg bw
95% CL:
> 2 883 - < 3 552
Remarks on result:
other: 48 hours; Test substance: Rare Earth Solution Code #1455
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 621 mg/kg bw
95% CL:
> 2 361 - < 2 909
Remarks on result:
other: 48 hours; Test substance: Lanthanum chloride, anhydrous
Mortality:
4470 mg/kg: 8 out of 10 died within 24 h, 1 out of 10 died within 48 h
3550 mg/kg: 6 out of 10 died within 24 h, 2 out of 10 died within 48 h
2820 mg/kg: 2 out of 10 died within 24 h, no further deaths within 48 h
Clinical signs:
4470 mg/kg: all animals were prostate after dosing and at 4 h.
3550 mg/kg: all animals were lethargic after dosing and didn´t recover until they died or were sacrificed.
2820 mg/kg: all animals were lethargic after dosing and at 4 h; after 24 h 2 animals were found dead, the others appeared normal
Body weight:
Mean body weight:
4470 mg/kg; males: at the beginning of the test 176 g; Females: at the beginning of the test 153 g, after 48 h 145 g (one animal)
3550 mg/kg; males: at the beginning of the test 169 g, after 48 h 165 g (one animal); Females: at the beginning of the test 151 g, after 48 h 150 g (one animal)
2820 mg/kg; males: at the beginning of the test 114 g, after 48 h 125 g (three animals); Females: at the beginning of the test 107 g, after 48 h 125 g (five animal)
Gross pathology:
4470 mg/kg: dead animals: test solution in stomach and intestine; sacrificed animal: no gross pathology - Diarrhea
3550 mg/kg: dead animals: test solution in stomach and intestine; sacrificed animals: no gross pathology - Diarrhea
2820 mg/kg: dead animals: test solution in stomach and intestine; sacrificed animals: no gross pathology (3 animals) or distended stomachs (5 animals)
No gross pathology was performed with surviving animals.

Any other information on results incl. tables

Mortality:

Concentration (mg/kg)

Mortality: No. Dead / No. Dosed

4 h

24 h

48 h

males

 

 

 

4480

0/5

4/5

1/5

3550

0/5

4/5

0/5

2820

0/5

2/5

0/5

females

 

 

 

4480

0/5

4/5

0/5

3550

0/5

2/5

2/5

2820

0/5

0/5

0/5

Applicant's summary and conclusion