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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
other: Regulation
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: Regulation
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:
Saccharomyces cerevisiae, ext.
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name of test material (as cited in study report): Yeast extract (SPRINGER 0251 / 0-MG-L)
- Substance type: Powder
- Physical state: light brown powder
- Analytical purity: Not indicated by the sponsor; treated as 100% pure
- Lot/batch No.: 071403960
- Expiration date of the lot/batch: 31 August 2017
- Stability under storage conditions: stable
- Storage condition of test material: At room temperature
- Solubility in water: very soluble (> 10000 mg/L) at 50°C and pH 5 to 5.5

Test animals

Species:
other: Not applicable

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

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

Results (fetuses)

Effect levels (fetuses)

Key result
Dose descriptor:
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 developmental toxicity

Key result
Developmental effects observed:
not specified
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.