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EC number: 267-041-6 | CAS number: 67763-18-2
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (December 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given
- Substance type: pure active substance
- Analytical purity: no data
- Physical state: liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River - Calco CO, Italy
- Age at study initiation: no data
- Weight at study initiation: 18 - 20 g
- Assigned to test groups randomly: yes
- Housing: in groups of 5 in transparent polycarbonate cages (dimensions 355x235x19 mm)
- Diet: standard pellet complete diet ad libitum
- Water: filtered tap water from local network ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
The housing room conditions of temperature and humidity were maintained by the conditioning plant and continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: March 18, 1994 To: March 21, 1994
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: sesame seed oil
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: 250 mg/mL
- Amount of vehicle (if gavage or dermal): 50 mL/kg bw
- Lot/batch no. (if required): no data
- Purity: no data - Details on exposure:
- A solution was prepared in sesame seed oil at a concentration of 250 mg/mL. Animals were treated in a single dose by intraperitoneal injection.
- Duration of treatment / exposure:
- 24, 48 and 72 hours
- Frequency of treatment:
- single intraperitoneal injection
- Post exposure period:
- none
Doses / concentrations
- Remarks:
- Doses / Concentrations:
12500 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide in physiological saline
- Justification for choice of positive control(s): no data
- Route of administration: intraperitoneal injection
- Doses / concentrations: volume administration: 50 mL/kg bw; dose: 75 mg/kg bw
Examinations
- Tissues and cell types examined:
- Preparation of the bone marrow were made on slides.
Poly- and normochromatic erythrocytes and micronucleated polychromatic erythrocytes were counted. - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: no data
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 24, 48 and 72 hours
DETAILS OF SLIDE PREPARATION: Thigh-bones were removed and cleaned from muscles. The heads of the femur was removed and foetal calf serum was introduced in the femur channel by means of a thin needle. The bone marrow cells coming out from the other side of the thigh-bone were collected in a test tube, then centrifugated for 10 min at 1000 rpm. The supernatant was removed and cells resuspended in 10 µL of foetal calf serum, smeared on slides, air-dried and stained with May Grunland and Giemsa solutions.
METHOD OF ANALYSIS: The slidas wer observed with an aptic microscope, chossing the areas showed the best distribution of cells and a perfect staining. For each animal 1000 polychromatic erythrocytes were counted, and the frequence of normochromatic and of micronucleated polychromatic erythrocytes were recorded. - Evaluation criteria:
- The following data were evaluated:
- difference between the number of micronucleated polychromatic erythrocytes in the treatment group and negative control
- difference between the number of micronucleated polychromatic erythrocytes in the treatment group and positive control
- difference between the number of micronucleated polychromatic erythrocytes in the negative control and positive control
- difference between the proportion of polychromatic/normochromatic erythrocytes in the treatment group and negative control
- difference between the proportion of polychromatic/normochromatic erythrocytes in the treatment group and positive control
- difference between the proportion of polychromatic/normochromatic erythrocytes in the negative control and positive control - Statistics:
- The data obtained from the proportional relationship between the polychromatic erythrocytes and the normochromatic erythrocytes was statistically evaluated by means of Student's t-test with 95% probability.
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:
- The difference between the number of micronucleated polychromatic erythrocytes in the treatment group and negative control is not significant.
The difference between the number of micronucleated polychromatic erythrocytes in the treatment group and positive control is significant.
The difference between the number of micronucleated polychromatic erythrocytes in the negative control and positive control is significant.
The difference between the proportion of polychromatic/normochromatic erythrocytes in the treatment group and negative control is not significant.
The difference between the proportion of polychromatic/normochromatic erythrocytes in the treatment group and positive control is significant.
The difference between the proportion of polychromatic/normochromatic erythrocytes in the negative control and positive control is significant.
Any other information on results incl. tables
Table #1: Mean of micronucleated polychromatic erythrocytes | ||||||||||||
Concentration [mg/kg bw] |
Sampling time | |||||||||||
24 h | 48 h | 72 h | ||||||||||
¿ | ¿ | ¿ | ¿ | ¿ | ¿ | |||||||
12500 | 1.40 ± 1.14 | 1.60 ± 1.14 | 1.60 ± 1.14 | 1.60 ± 1.52 | 1.60 ± 1.34 | 2.00 ± 1.22 | ||||||
Positive control | 33.00 ± 4.83 | 35.00 ± 4.5 | 35.00 ± 3.94 | 38.00 ± 2.30 | * | * | ||||||
Negative control | 1.80 ± 1.30 | 1.60 ± 1.14 | 1.60 ± 1.14 | 2.20 ± 1.48 | 1.20 ± 1.30 | 2.20 ± 1.30 | ||||||
Table #2: Ratio polychromatic/normochromatic erythrocytes | ||||||||||||
Concentration [mg/kg bw] |
Sampling time | |||||||||||
24 h | 48 h | 72 h | ||||||||||
¿ | ¿ | ¿ | ¿ | ¿ | ¿ | |||||||
12500 | 2.24 ± 0.24 | 2.28 ± 0.25 | 2.32 ± 0.25 | 2.28 ± 0.23 | 2.20 ± 0.24 | 2.28 ± 0.29 | ||||||
Positive control | 0.90 ± 0.00 | 0.88 ± 0.04 | 0.82 ± 0.04 | 0.80 ± 0.07 | * | * | ||||||
Negative control | 2.40 ± 0.10 | 2.36 ± 0.26 | 2.00 ± 0.25 | 2.28 ± 0.29 | 2.00 ± 0.21 | 2.26 ± 0.24 | ||||||
* = only platelets and blasts were observed | ||||||||||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test material Bis(C12-C13)alkyl-2-hydroxybutandioate did not cause damage to this mitotic system under the conditions of the study.
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