Registration Dossier
Registration Dossier
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EC number: 201-506-6 | CAS number: 83-86-3
Acute Toxicity: oral
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:
- 1 987
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
- 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
- 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)
Constituent 1
Constituent 2
- 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.
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