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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
two-generation reproductive toxicity
Type of information:
other: Review
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
no guideline required
Guideline:
other: Not applicable
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Saccharomyces cerevisiae, ext.
EC Number:
283-294-5
EC Name:
Saccharomyces cerevisiae, ext.
Cas Number:
84604-16-0
Molecular formula:
Not applicable as the substance is an UVCB
IUPAC Name:
Yeast extract, Saccharomyces cerevisiae
Details on test material:
- Name of test material (as cited in study report): Saccharomyces cerevisiae, Extract (Springer 0204/0-LQ-L)
- Molecular formula: -
- Molecular weight: -
- Substance type: Brown liquid
- Physical state: liquid
- Analytical purity: 48.0 – 52.0% (dry matter)
- Impurities (identity and concentrations): -
- Composition of test material, percentage of components: -
- Isomers composition: -
- Purity test date: -
- Lot/batch No.: 081000310
- Expiration date of the lot/batch: 30 April 2012
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Other: -

Test animals

Species:
other: Not applicable

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
other: Not applicable
Effect level:
0 other: Not applicable
Based on:
other: Not applicable
Sex:
not specified
Basis for effect level:
other: Not applicable
Remarks on result:
other: Not applicable

Results: P1 (second parental generation)

Effect levels (P1)

Key result
Dose descriptor:
other: Not applicable
Remarks:
Not applicable
Based on:
other: Not applicable
Remarks:
Not applicable
Sex:
not specified
Basis for effect level:
other: Not applicable
Remarks on result:
other: Not applicable
Remarks:
Not applicable

Results: F1 generation

Effect levels (F1)

Key result
Dose descriptor:
other: Not applicable
Generation:
other: Not applicable
Based on:
other: Not applicable
Sex:
not specified
Basis for effect level:
other: Not applicable
Remarks on result:
other: Not applicable

Results: F2 generation

General toxicity (F2)

Food efficiency:
not examined

Effect levels (F2)

Key result
Dose descriptor:
other: Not applicable
Generation:
other: Not applicable
Effect level:
0 other: Not applicable
Based on:
other: Not applicable
Sex:
not specified
Basis for effect level:
other: Not applicable
Remarks on result:
other: Not applicable

Overall reproductive toxicity

Key result
Reproductive effects observed:
not specified
Lowest effective dose / conc.:
0 other: Not applicable
Treatment related:
not specified

Applicant's summary and conclusion

Conclusions:
Yeast extracts are classified as flavouring preparations, and as per Art. 9 and 10 of this regulation, do not require pre-market authorisation. 
Executive summary:

The use of yeast extracts in food is covered by the European Parliament and Council Regulation (EC) No 1334/2008 of 16th December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods, where extracts are classified as flavouring preparations, and as per Art. 9 and 10 of this regulation, do not require pre-market authorisation.