Peptones, casein

Acute Toxicity: oral

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

Test material information

Constituent 1

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".