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Administrative data

Description of key information

The Merck Index, Cosmetic Ingredient review, Lent et al (2017)

The acute oral LD50 of the substance to mice was reported to be 505 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
secondary literature
Reference:
Composition 0
Qualifier:
no guideline available
Principles of method if other than guideline:
Groups of 10 fasted female white Swiss mice received test material orally. They were observed for two weeks following dosing and underwent necropsy.
Review references Webster et al. 1957 (Webster SH, Rice ME, Highman B, Von Oettingen WF (1957) The toxicology of potassium and sodium iodates: acute toxicity in mice. J Pharmacol Exp Ther 120: 171-8)
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Test material information:
Composition 1
Specific details on test material used for the study:
- 6 %
Species:
mouse
Strain:
Swiss
Route of administration:
oral: unspecified
No. of animals per sex per dose:
10 females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
505 mg/kg bw
Based on:
not specified

Signs of intoxication included diarrhoea, alternate hyperactivity and lassitude, followed by weakness, prostration, and dyspnea. At higher doses, death was often preceded by excitability and convulsions. Haemoglobinuria occurred in many of the animals. Animals that survived 2 weeks following dosing underwent necropsy. At microscopic examination, lesions, such as degeneration of many parietal cells of the gastric glands, were observed in animals dosed with 463 mg/kg test material.

Interpretation of results:
other: Category 4 according to EU criteria
Conclusions:
Under the conditions of the study the acute oral LD50 of the test material to female Swiss mice was 505 mg/kg.
Executive summary:

Groups of 10 fasted female white Swiss mice received test material orally. They were observed for two weeks following dosing and underwent necropsy.

Signs of intoxication included diarrhoea, alternate hyperactivity and lassitude, followed by weakness, prostration, and dyspnea. At higher doses, death was often preceded by excitability and convulsions. Haemoglobinuria occurred in many of the animals. Animals that survived 2 weeks following dosing underwent necropsy. At microscopic examination, lesions, such as degeneration of many parietal cells of the gastric glands, were observed in animals dosed with 463 mg/kg test material.

Under the conditions of the study the acute oral LD50 of the test material to female Swiss mice was 505 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not specified
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Reference:
Composition 0
Qualifier:
no guideline available
Principles of method if other than guideline:
Effects following acute oral exposure to female mice are reported.
GLP compliance:
not specified
Remarks:
GLP compliance not specified in publication
Test material information:
Composition 1
Species:
mouse
Sex:
not specified
Route of administration:
oral: unspecified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
505 mg/kg bw
Based on:
not specified

Reported effects of sodium iodate and potassium iodate oral exposure included alternate hyperactivity and lassitude, weakness, prostration, dyspnea, and diarrhoea. Transient increases in gastrointestinal pH and degeneration of parietal cells, haemolytic effects including haemoglobinuria and haemosiderin deposits in the kidneys were observed. Mortality was attributed to renal damage.

Interpretation of results:
other: Category 4 according to EU criteria
Conclusions:
The acute oral LD50 of the test material to mice is reported to be 505 mg/kg.
Executive summary:

The acute oral LD50 of the test material to mice is reported to be 505 mg/kg.

Reported effects of sodium iodate and potassium iodate oral exposure included alternate hyperactivity and lassitude, weakness, prostration, dyspnea, and diarrhoea. Transient increases in gastrointestinal pH and degeneration of parietal cells, haemolytic effects including haemoglobinuria and haemosiderin deposits in the kidneys were observed. Mortality was attributed to renal damage.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
Valid with restrictions. This is peer reviewed data where the test methodology and identity of the substance have been evaluated, and a reliable and representative value for the endpoint has been selected. No information on GLP status or test guideline followed is available.
Reference:
Composition 0
Qualifier:
no guideline available
Principles of method if other than guideline:
Handbook data does not specify the method. Data from peer reviewed source.
GLP compliance:
not specified
Test type:
other: Handbook data does not specify the method. Data from peer reviewed source.
Test material information:
Composition 1
Species:
mouse
Sex:
female
Route of administration:
oral: unspecified
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
505 mg/kg bw
Based on:
not specified
Interpretation of results:
other: Category 4 according to EU criteria
Conclusions:
According to the handbook data the acute oral LD50 of the test material to female mice is 505 ± 26 mg/kg.
Executive summary:

According to the handbook data the acute oral LD50 of the test material to female mice is 505 ± 26 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
505 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 Oral Toxicity

The Merck Index

According to the handbook data the acute oral LD50 of the test material to female mice is 505 ± 26 mg/kg.

Cosmetic Ingredient Review

Groups of 10 fasted female white Swiss mice received test material orally. They were observed for two weeks following dosing and underwent necropsy.

Signs of intoxication included diarrhea, alternate hyperactivity and lassitude, followed by weakness, prostration, and dyspnea. At higher doses, death was often preceded by excitability and convulsions. Hemoglobinuria occurred in many of the animals. Animals that survived 2 weeks following dosing underwent necropsy. At microscopic examination, lesions, such as degeneration of many parietal cells of the gastric glands, were observed in animals dosed with 463 mg/kg test material.

Under the conditions of the study the acute oral LD50 of the test material to female Swiss mice was 505 mg/kg.

Lent et al. (2017)

The acute oral LD50 of the test material to mice is reported to be 505 mg/kg.

Reported effects of sodium iodate and potassium iodate oral exposure included alternate hyperactivity and lassitude, weakness, prostration, dyspnea, and diarrhea. Transient increases in gastrointestinal pH and degeneration of parietal cells, hemolytic effects including hemoglobinuria and hemosiderin deposits in the kidneys were observed. Mortality was attributed to renal damage.

Murray (1953)

The test material was dosed to groups of 10 mice at dose levels of 250, 750 and 2500 mg/kg bw.

No symptoms were reported in the group dosed at 250 mg/kg bw. At the dose level of 750 mg/kg bw 7 of the 10 animals died within 3 weeks. At 2500 mg/kg bw all of the animals died within 12 hours.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance requires classification for acute oral toxicity (category 4) and is assigned the hazard statement "H302: Harmful if swallowed".