Registration Dossier
Registration Dossier
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EC number: 271-770-5 | CAS number: 68607-88-5 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of soya composed primarily of amino acids, peptides, and proteins. It may contain impurities consisting chiefly of carbohydrates and lipids along with smaller quantities of miscellaneous organic substances of biological origin.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October, November 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Protein hydrolyzates, soya
- EC Number:
- 271-770-5
- EC Name:
- Protein hydrolyzates, soya
- Cas Number:
- 68607-88-5
- IUPAC Name:
- Enzymatic hydrolysis products of Glycine soya
- Test material form:
- liquid
- Details on test material:
- Amber liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 12 Sprague Dawley rats (SPF Caw) originated from IFFA CREDO were used after a 5 to 6-day acclimatation period. At the beginning of the study, the animals weighted between 167 g and 196 g (males) and between 149 g and 184 (females).
Group 1 (control) : 3 male rats: Rm2597 to Rm2599 and 3 female rats: Rf2586 to Rf2588
Group 2 (treated): 3 male rats: Rm2671 to Rm2673 and 3 female rats: Rf2656 to Rf2658
Environmental parameters for the treated group:
temperature: 20-23°C
relative humidity: 37-52%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The animal of Group 2 received an effective dose of 2000 mg/kg body weight of product administred by forced-feeding under a volume of 2 ml/kg body weight using a suitable syring graduated fitted with an oesophageal metal cunula
- Doses:
- 2000 mg/kg body weight of product
- No. of animals per sex per dose:
- 3 male rats and 3 female rats
- Control animals:
- yes
- Remarks:
- Group 1 (control) : 3 male rats: Rm2597 to Rm2599 and 3 female rats: Rf2586 to Rf2588
- Details on study design:
- in order to minimize test volume variability in cases where the LD50 had to be determined, concentrations under investigation are adjusted so as to administer a constant volume of 2 to 10 ml/kg.
Variability in test volume should be minimised by adjusting the concentration to ensure a constant volume at all dose-levels. - Statistics:
- The value for LD50 and standard deviation are calculated for each sex and for the entire population (both sex together) using the parametric model for estimation of the LD50 using the probit analysis.
Results and discussion
- Preliminary study:
- /
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study
- Clinical signs:
- other: No clinical signs related to the administration of the test product were observed.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the product is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C Directives 67/548 and 99/45, the product must not be classified - Executive summary:
The test item was administered to a group of 6 Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423.
No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight.
the macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.
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