Registration Dossier
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EC number: 201-766-0 | CAS number: 87-69-4
- 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 germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented report equivalent or similar to OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report Date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): tartaric acid
- Physical state: fine granular
- Lot/batch No.: 71382
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 280-350 g
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: 1 to 5 per cage, sanitary cages and bedding were used, and changed two times per week, at which time water containers were cleaned, sanitized and filled. Once a week, cages were repositioned on racks; racks were repositioned within rooms monthly.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4-11 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: physiol. saline
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food): a commercial 4 % fat diet
- Storage temperature of food: periodic tests to verify the absence of coliforms, salmonella and pseudomones sp. were performed. - Duration of treatment / exposure:
- acute: one application
subacute: 5 days - Frequency of treatment:
- acute: one application
subacute: one dose a day for five days - Post exposure period:
- 8 weeks in acute test
7 weeks in subacute test
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1.25 mg/kg bw
Basis:
actual ingested
both in acute and subacute tests
- Remarks:
- Doses / Concentrations:
12.5 mg/kg bw
Basis:
actual ingested
both in acute and subacute tests
- Remarks:
- Doses / Concentrations:
125 mg/kg bw
Basis:
actual ingested
both in acute and subacute tests
- No. of animals per sex per dose:
- 10 male rats were assigned to each of 5 group in acute and subacute. Following treatment, the males were sequentially mated to 2 females per week for 8 weeks (7 in subacute study).
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine
- Route of administration: intraperitoneally
- Doses / concentrations: 0.3 mg/kg bw
Examinations
- Tissues and cell types examined:
- Corpora lutea, early fetal deaths, late fetal deaths and total implantations per uterine born
- Statistics:
- a. the fertility index
The number of pregnant females/number of mated females with the chi-square was used to compare each treatment to the control. Arbitrage’s trend was used for linear proportions to test whether the fertility index was linearly related to arithmetic or log dose.
b. totle number of implantations
the t-test was used to determine significant differences between average number of implantations per pregnant female for each treatment compared to the control. Regression techniques were used to determine whether the average number of implantations per female was related to the arithmetic or log dose.
c. total number of corpora lutea
the t-test was used to determine significant differences between average number of corpora lutea per pregnant female for each treatment compared to the control.
d. preimplantation losses
preimplantation loses were computed for each female by subtracting the number of implantations from the number of corpora lutea, Freeman-Tukey transformation was used on the preomplantation losses for each female and then the t-test was used to compare each treatment to control. Regression technique was used to determine whether the average number of preimplantation losses per female was related to the arithmetic or log dose.
Results and discussion
Any other information on results incl. tables
a. acute study
In general, significant differences between the negative control and experimental groups were shown in a few instances at vrious weeks throughout the parameter. Of note is the significant increase in average resorptions shown for the low dose group at week 8.
b. subacute study
Significant difference between the negative control and experiment groups were shown in a few instances. However, no strong indications of change were seen.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): ambiguous
no obviously results proved this substance is a potential mutagen - Executive summary:
The Dominant Lethal Test is an accurate and sensitive measure of the amount and type of fetal wastage which may occur following administration of a potential mutagen. In this test acute and subacute administration were carried out in rats, and the results can not be concluded that FDA 71 -55 is a potential mutagen.
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