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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
November 1978 - December 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted with OECD test guideline 401 without GLP certificate, so it can be considered as reliable with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Remarks:
Study performed before OECD 401 development
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Potassium iodide
EC Number:
231-659-4
EC Name:
Potassium iodide
Cas Number:
7681-11-0
IUPAC Name:
potassium iodide
Details on test material:
Merck article number 5040 (1980), Kaliumjodid
Charge 8570 463
Lot.: B 1147
Released by Analytisches Zentrallaboratorium of Merck at 15.6.78

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
10%
Doses:
2000, 2500, 2800, 3200, 3600, and 4000 mg/kg body weight
No. of animals per sex per dose:
10 male and 10 female individuals per dose, including control group
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 118 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 931 - <= 3 318
Remarks on result:
other: 1 day after administration
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 779 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 610 - <= 2 959
Remarks on result:
other: 7+14 after administration
Sex:
male
Dose descriptor:
LD50
Effect level:
3 129 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 874 - <= 3 408
Remarks on result:
other: 7 + 14 days after administration
Sex:
female
Dose descriptor:
LD50
Effect level:
2 484 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 289 - <= 2 696
Remarks on result:
other: 7 + 14 days after admonistration

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The results shows the 24 hour LD50 of iodide to rat was 3118 mg/kg bw which is higher than the criteria of 2000 mg/kg bw under the Regulation (EC) No. 1272/2008.
Executive summary:

In one company study (A. Hausner, G. Weise, and A. Hofmann, 1980), the effects of iodide were studied in male and female Wistar rats. In the test, 10 male and 10 female in each dose and control groups were administrated with potassium iodide for 14 days at dose of 0 (control), 2000, 2500, 2800 3200, 3600, and 4000 mg/kg body weight mg/kg bw respectively. The key value of LD50 was calculated by Probit-analysis (Fink und Hund 1965).

The 24 hour LD50 of iodide to rats (male/female) was calculated to be 3118 mg/kg bw under test conditions.

7-14 days LD50 of iodide to rats (male/female) was calculated to be 2779 mg/kg bw under test conditions.

Besides of the results on mortality, some other non-lethal effects were also investigated. 5-15 min after application first symptoms of poisoning was observed. The main symptoms were: lethargy, exophthalmus, stagger, dypsnoe, ruffled fur. The symptoms could be observed in all dosing in the first 72h. Staggering was observed up to 5 days. The 2000mg/kg bw group showed no symptoms beside stagger after 48h. A part of the 2500mg/kg bw, 2800mg/kg bw and 3200mg/kg bw groups showed ventral position and paralysis of extremities in the period from 1-24h. Apart from stagger this group showed no symptoms after 72h.

The 3600mg/kg bw group showed ventral position and paralysis of extremities in the period from 1-24h. Slight symptoms of lethargy and dyspnoe could be observed up to 5 days after administration. Slight stagger could be observed up to 7 days after administration.

The 4000mg/kg bw group showed ventral position and paralysis of extremities in the period from 1-24h. Ventral position could be be observed temporarily up to 5 days. Symptoms of lethargy and dyspnoe could be observed up to 5 days after administration.

All surviving animals showed no symptoms after 7 days.