Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Single oral administration
GLP compliance:
no
Remarks:
Study carried out in 1987, before 1 June 2008 (refering to REACH Article 13(4))
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fytic acid
EC Number:
201-506-6
EC Name:
Fytic acid
Cas Number:
83-86-3
Molecular formula:
C6H18O24P6
IUPAC Name:
fytic acid
Constituent 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Aqua; Water
Test material form:
liquid
Details on test material:
Composition
Estimated composition based on all analyses :-
44.7% (w/w) water
49.8% (w/w) inositol hexaphosphoric acid
5.5% (w/w) partially phosphorylated inositol (e.g. inositol tetraphosphoric acid)
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Sample was diluted with water. For applied doses (mg/kg bw) please refer to Table 1 in section "Illustration (picture/graph)".

Test animals

Species:
mouse
Strain:
ICL-ICR
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Doses:
- 490 / 740 / 1110 / 1160 / 2500 mg/kg bw (females and males)
- 800 / 960 / 1150 / 1390 / 1670 mg/kg bw (females)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 72 hr
- Frequency of observations and weighing: no weighing
- Other examinations performed: clinical signs
Statistics:
- Litchfield Wilcoxon
- Moving Average

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 150 mg/kg bw
Based on:
test mat.
95% CL:
>= 910 - <= 1 410
Remarks on result:
other: statistics: Litchfield-Wilcoxon
Sex:
female
Dose descriptor:
LD50
Effect level:
1 160 mg/kg bw
Based on:
test mat.
95% CL:
>= 930 - <= 1 440
Remarks on result:
other: Statistics: Moving Average
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
900 mg/kg bw
Based on:
test mat.
95% CL:
>= 540 - <= 1 490
Remarks on result:
other: Statistics: Litchfield-Wilcoxon
Sex:
male
Dose descriptor:
LD50
Effect level:
900 mg/kg bw
Based on:
test mat.
95% CL:
>= 520 - <= 1 560
Remarks on result:
other: Statistics: Moving Average
Mortality:
Most of the deaths in treated male mice occurred within 1 h after administration, whereas those in treated female mice occurred between 1 and 48 h.
For more details please see the attached illustration.
Clinical signs:
other: In the substance-treated animals the following clinical signs were observed: - thinning of the stomach and small intestinal walls - bleeding of the glandular portion of the stomach - hypertrophy of the gallbladder

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 values for acute toxicity (oral) in mice (ICL-ICR) of the test item were reported to be 1150 mg/kg bw (female) and 900 mg/kg bw (male).
Executive summary:

The oral LD50 values of the substance in mice (ICL-ICR) were reported to be 900 (males) and 1150 (females) mg/kg body weight (Litchfield-Wilcoxon statistics).

Most of the deaths in male mice occured within 1h after administration, whereas those in treated female mice occured between 1 and 48h after administration. Thinning of the stomach and small intestinal walls, bleeding of the glandular portion of the stomach, and hypertrophy of the gallbladder were seen in the treated animals.