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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A well documented GLP study according to OECD guideline
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
There is number of unifying considerations justifying the similarity between the two substances:
- Similarity of synthesis: the two substances are obtained by an acidic alkaline or enzymatic hydrolysis of protein.
- Similarity of use: the two substances are used in industrial and biotechnological applications as a supplement to cell culture, food for aquatic organisms and animals.
- Similarity of toxicokinetic behavior: the two substances are composed primarily of amino acids which are completely metabolized. Once ingested the two substances follow the same ways of absorption, distribution, metabolism and elimination.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached read across justification document)

3. ANALOGUE APPROACH JUSTIFICATION
The read-across substance, as compared to the target substance, is more soluble (1,896 g/L and 8.82 – 28.96 g/L, respectively) and thus provides a conservative read-across due to increased bioavailability.

4. DATA MATRIX
See attached justification document.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Peptones, casein
EC Number:
293-428-4
EC Name:
Peptones, casein
Cas Number:
91079-40-2
Molecular formula:
Not applicable
IUPAC Name:
Peptones, casein
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/Kg bw
No. of animals per sex per dose:
6 females
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the results obtained in the study and according to the Globally Harmonized System (GHS), the test item is classified as Category 5/Not classified.
Under the system currently used in the European Union (Directive 2004/73/EC, Annex 2B) and the criteria published in the Official Journal of the European Communities 6 August 2001 (Directive 2001/59/EC, Annex VI), we conclude that the product MOSCA TRAP is considered "NOT CLASSIFIED", so there is no need to assign risk notation. Hence, based on the read across from this supporting substance, peptone casein are considered as well "NOT CLASSIFIED".