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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1970
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report for SIAM 24 (Paris, France, 17-20 April).
Author:
OECD Organisation for Economic Co-operation and Development
Year:
2007
Bibliographic source:
Self-published, Paris, France. 138 p.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study was conducted to investigate some of the important factors in the toxicity of iron salts with regard to the treatment of acute iron poisoning in humans. There were limited study details, such as environmental conditions and detail regarding the test substance, in the publication.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ferric chloride
- Substance type: Iron salt
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:
mouse
Strain:
other: Queckenbusch
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 'Mature' (no further information)
- Weight at study initiation: No data
- Fasting period before study: 19 ±2 hours
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data


IN-LIFE DATES: No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.01ml/g bw
Doses:
186, 335, 604, 1087 mg Fe/kg bw, equivalent to 540, 974, 1,756, 3160 mg ferric chloride/kg bw
No. of animals per sex per dose:
20 females (no males)
Control animals:
other: these were the control animals
Details on study design:
- Duration of observation period following administration: At least one month
- Frequency of observations and weighing: Only mortality data reported
- Necropsy of survivors performed: no
- Other examinations performed: None reported
Statistics:
LD50 determined using the tables of Weil (1952) when applicable. In other instances the graphic method of Litchfield et al. (1949) was used.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
1 300 mg/kg bw
Based on:
test mat.
Remarks:
FeCl3
Sex:
female
Dose descriptor:
LD50
Effect level:
440 mg/kg bw
Based on:
element
Remarks:
Fe
95% CL:
>= 300 - <= 630
Mortality:
186 mgFe/kg - 1/10
335 mgFe/kg - 2/10
604 mgFe/kg - 8/10
1087 mgFe/kg - 10/10
Clinical signs:
Not reported
Body weight:
Not reported
Gross pathology:
Not reported
Other findings:
None

Any other information on results incl. tables

Table: Mortality data

Dose

Number of deaths

mg Fe/kg bw

mg ferric chloride/kg bw

186

540

1

335

974

2

604

1756

8

1087

3160

10

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study (reliability score 2, not to GLP) in which a control group of mice were given ferric chloride the LD50 was 440 mg Fe/kg bw, equivalent to 1,300 mg ferric chloride/kg body weight.
Executive summary:

In an acute oral toxicity study (reliability score 2, not to GLP) in which a control group of mice (20 females) were given ferric chloride at doses of 186, 335, 604, 1087 mg Fe/kg bw (equivalent to 540, 974, 1,756, 3160 mg ferric chloride/kg bw) by oral gavage, and then observed for one month, the LD50 was 440 mg Fe/kg bw (equivalent to 1,300 mg ferric chloride/kg body weight). This value was based on 1/10, 2/10, 8/10 and 10/10 deaths in the 186, 335, 604, 1087 mg Fe/kg bw groups, respectively.