Dilanthanum tricarbonate

Acute Toxicity: inhalation

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Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF, Notification No. 12 Nousan-8147

Deviations:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 4 509 mg/m³ air (analytical)

Exp. duration:

4 h

Remarks on result:

other: recalculated value to Lanthanum carbonate

Effect levels 2

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 928 mg/m³ air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: original value: Lanthanum carbonate octahydrate

Any other information on results incl. tables

Atmosphere characterisation:

	Date of exposure	Sampled volume (L) / flow rate (L/min.)	Target concentration (mg/m³ air)	Gravimetric concentrations (mg/m³ air)	Mean concentration (mg/m³ air)
Group 1 (Control)	18.08.2009	n.a.	-	0	n.a.
Group 2	08.09.2004	10/4	5000	5780 6990 5310 5630	5928

n.a. not applicable

Body weights:

Group 1: control males (all data in g):

	Postexposure day (d)
animal	0	3	7	14
1	192	201	232	267
2	189	204	240	281
3	181	200	234	279
4	193	213	257	310
5	193	212	249	288
mean	189.6	206.0	242.4	285.0
STD	5.1	6.1	10.5	15.9

Group 2: 5000 mg/m³ males (all data in g):

	Postexposure day (d)
animal	0	3	7	14
11	184	199	228	264
12	191	204	233	277
13	185	195	218	247
14	197	213	245	290
15	169	182	216	255
mean	185.2	198.6	228.0	266.6
STD	10.4	11.5	11.8	17.2

Group 3: control females (all data in g):

	Postexposure day (d)
animal	0	3	7	14
6	173	173	183	191
7	174	177	187	195
8	176	173	184	198
9	175	173	187	191
10	169	171	182	190
mean	173.4	173.4	184.6	193.0
STD	2.7	2.2	2.3	3.4

Group 4: 5000 mg/m³ females (all data in g):

	Postexposure day (d)
animal	0	3	7	14
16	175	175	184	195
17	162	163	167	177
18	168	175	183	189
19	166	164	171	196
20	164	166	175	187
mean	167.0	168.6	176.0	188.8
STD	5.0	5.9	7.4	7.6

Body weight gain (all data in g):

	Postexposure day (d)
	3	7	14
Group 1: control males
mean	16.4	36.4	42.6
STD	4.6	4.8	6.8
Group 2: 5000 mg/m³ males
mean	13.4	29.4	38.6
STD	2.3	4.2	6.5
Group 3: control females
mean	0.0	11.2	8.4
STD	2.5	1.6	3.6
Group 4: 5000 mg/m³ females
mean	1.6	7.4	12.8
STD	3.4	2.1	7.2

Gross necropsy findings:

Individual findings/male rats (significant differences, P = 0.004):

	Animal no.	Sacrificed after	Pathology findings
Control	1-5	14 d	No observable findings
5000 mg/m³	11	14 d	Lung: less collapsed, gray-red, isolated whitish areas
	12	14 d	Lung: less collapsed, gray-red, isolated whitish areas
	13	14 d	Lung: less collapsed, gray-red
	14	14 d	Lung: less collapsed, gray-red, isolated whitish areas
	15	14 d	Lung: less collapsed, gray-red, isolated whitish areas; incisive teeth missing

Individual findings/female rats (significant differences, P = 0.004):

	Animal no.	Sacrificed after	Pathology findings
Control	6-10	14 d	No observable findings
5000 mg/m³	16	14 d	Lung: gray-red
	17	14 d	Lung: gray-red
	18	14 d	Lung: gray-red
	19	14 d	Lung: less collapsed, gray-red
	20	14 d	Lung: gray-red