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EC number: 283-294-5 | CAS number: 84604-16-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Saccharomyces cerevisiae, Saccharomycelaceae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11-14 September, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to GLP and OCED 474, conducted on two surrogates which have comparable composition
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Principles of method if other than guideline:
- The test was performed according to OECD 474.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Gistex standard powder, autolyzed yeast extract
- IUPAC Name:
- Gistex standard powder, autolyzed yeast extract
- Details on test material:
- The test material was identified by the following information: "Gistex Standard Powder, Autolyzed yeast extract. FM 8850-03. 20-6-1989".
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, F.R. Germany.
- Age at study initiation: young adult
- Weight at study initiation: mean weight in range 30.7-31.8 g (M) or 23.9-25.8 g (F)
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: males individually and females 5/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1°C
- Humidity (%): 57-82%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark
IN-LIFE DATES: From 11-14 September, 1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: not provided but from other studies it appeared that the test material is soluble in water.
- Concentration of test material in vehicle: 20% w/v
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw
- Type and concentration of dispersant aid (if powder): not relevant
- Lot/batch no. (if required): not relevant
- Purity: no data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: the solutions were prepared just prior to use.
- Duration of treatment / exposure:
- Single oral dose to 15 animals/sex (6 animals/sex for positive control); 5 animals/sex (2 animals/sex for positive control) were sacrificed for bone marrow collection at 24, 48 and 72 hours post-dose.
- Frequency of treatment:
- Single oral dose.
- Post exposure period:
- not relevant
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 15 animals/sex for Gistex treatment and vehicle control, 6 animals/sex for positive control; this provided for 5 animals/sex (2 animals/sex for positive control) for bone marrow collection at 24, 48 and 72 hours post-dose.
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- mitomycin C
- Justification for choice of positive control(s): recommended by OECD 474
- Route of administration: intraperitoneal
- Doses / concentrations: 1.5 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow from dissection of femur
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: highest dose recommended by OECD 474
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):see above
DETAILS OF SLIDE PREPARATION: Glass-drawn smears of bone marrow were prepared (two smears per animals).
METHOD OF ANALYSIS: The incidence of MPE (micronucleated polychromatic erythrocytes) and MNE (micronucleated normochromatic erythrocytes) and the total numbers of PE (polychromatic erythrocytes) and NE (normochromatic erythrocytes) were recorded in a total of at least 2000 and maximally 3000 E (erythrocytes) per animal, in such a way that a minimum of 1000 E was observed, if feasible.
OTHER: - Evaluation criteria:
- None reported.
- Statistics:
- In the first step, the fraction of MPE, MNE and ME per counted numer of PE, NE and E, respectively, were analysde with a generalized linear model using a binomial error-distribution, and the numbers of PE per 1000 E were analyzed with linear regression techniques. As a second stage, a posteriori comparisons of treatment groups with negative controls were carried out with asymptotic t-tests if either the main effect of treatment or the treatment by sex interaction was significant.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No signs of intoxiciation were observed. Mean body weigths of test and control anaimals were comparable in males and females.
For results of microscopic evalaution see tables below.
The incidence of MPE, MNE and ME per 1000 PE, NE and E, respectively were comparable between controls and test animals at all harvest times. The positive control gave the expected response.
PE counts per 1000 E were statistically different after 48 hours in males and females treated with Gistex. This finding is considered to be of doubtful toxicological significance as there was no consistent trend in time, and as there were opposite changes in males and females. The report also stated that all values were within the range normally seen in controls, but historical control data to verify this statement were not presented in the report.
Any other information on results incl. tables
Table 1. Group mean numbers of micronucleated erythrocytes per 1000 PE, 1000 NE and 1000 E.
dose |
males |
females |
||||||
parameter |
treatment |
/kg bw |
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
mean number of MPE/1000 PE |
water |
10 mL |
0.3 |
1 |
0.8 |
0.6 |
0.7 |
1 |
Gistex |
2000 mg |
0.9 |
0.9 |
0.6 |
1.1 |
0.8 |
0.4 |
|
MC |
1.5 mg |
50.4*** |
12.0** |
1.2 |
25.0*** |
14.6*** |
3.8 |
|
mean number of MNE/1000 NE |
water |
10 mL |
0.7 |
0.6 |
0.6 |
0.6 |
1.5 |
0.9 |
Gistex |
2000 mg |
0.8 |
0.7 |
0.7 |
1 |
0.7 |
0.9 |
|
MC |
1.5 mg |
6.5*** |
4.6*** |
0 |
2.4* |
7.1*** |
2.3 |
|
mean number of ME/1000E |
water |
10 mL |
0.5 |
0.8 |
0.7 |
0.6 |
1.1 |
1 |
Gistex |
2000 mg |
0.9 |
0.8 |
0.6 |
1.1 |
0.8 |
0.6 |
|
MC |
1.5 mg |
20.3*** |
5.6*** |
0.2 |
11.2*** |
8.8*** |
2.7* |
* p<0.05; ** p<0.01; *** p<0.001
PE = polychromatic erythrocytes
NE = normochromatic erythrocytes
E = erythrocytes (PE + NE)
MPE, MNE, ME = micronucleated PE, NE, E, respectively
MC = mitomycin C
Table 2. Group mean numbers of PE per 1000 E.
dose |
males |
females |
||||||
parameter |
treatment |
/kg bw |
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
mean number of PE/1000 E |
water |
10 mL |
572 |
428 |
518 |
470 |
555 |
436 |
Gistex |
2000 mg |
519 |
564*** |
513 |
534 |
455* |
462 |
|
MC |
1.5 mg |
319*** |
156*** |
198*** |
430 |
236*** |
258*** |
* p<0.05; ** p<0.01; *** p<0.001
PE = polychromatic erythrocytes
E = erythrocytes
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In a mouse micronucleus test conducted at a single oral dose dose of 2000 mg/kg bw (harvest times 24, 48 and 72 hours post-dose), the test substance was negative.
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