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EC number: 601-327-7 | CAS number: 114772-54-2
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 5 April 1995 to 18 May 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Score micronuclei in rat bone marrow polychromatic erythrocytes (PCEs) after in vivo treatment to evaluate a clastogenic effect of the test compound.
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4'-(bromomethyl)-[1,1'-biphenyl]-2-carbonitrile
- EC Number:
- 601-327-7
- Cas Number:
- 114772-54-2
- Molecular formula:
- C14H10BrN
- IUPAC Name:
- 4'-(bromomethyl)-[1,1'-biphenyl]-2-carbonitrile
- Details on test material:
- Test compound/batch: SR 48941/Batch 5 SNP 003
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: OFA-SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Iffa Credo, Domaine des Oncins, 69210 l'Arbresle, France
- Acclimation: Animals were allowed to acclimate to our animal facilities for approximately 1 week before the beginning of treatment.
- Age and weight: Animals were approximately 6 weeks old when treatment began, and the initial body weight range was 201-250 g for males and 168-202 g for females.
- Selection and assignment: All animals (37 per sex) underwent clinical examinations, and 35 per sex, considered to be in satisfactory health, were randomly assigned to experimental groups; 10 males and 10 females were used for testing another compound in a study run simultaneously.
- Number of animals/group: 10 males and 10 females for the vehicle control and the treated groups, 5 males and 5 females for the positive control group.
- Diet: Animals were fed ad libitum AO4 c, a complete commercial diet from U.A.R. The diet had been analyzed to control for nutritive quality and contaminant presence (bacteria, mycotoxins, organochlorine and organophosphate pesticides, heavy metals, and nitroso derivatives); the manufacturers supplied a certificate of analysis with each batch.
- Water supply: The animals were allowed free access to tap-water through automatic waterers. Routine physical, chemical, and bacteriological assays of water sampled from the animal facilities were performed twice yearly, and assays for the presence of heavy metals yearly, by the regional water control laboratory.
Environmental conditions in animal rooms:
- Temperature 22 +/- 2 °C
- Relative humidity: 60 +/- 10%
- Light cycle: 12/24 hours
- Air flow: 12 changes hour without recirculation.
- Temperature and relative humidity were recorded continuously.
Husbandry: The animals were housed 5 of the same sex and group to a wire mesh bottom, stanless steel cage (369 cm² x 18 cm)/
Identification: Ear tattoo.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Suspension in 0.6% methylcellulose solution
- Frequency of treatment:
- Single administration
- Post exposure period:
- 48h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500 mg/kg
Basis:
- No. of animals per sex per dose:
- Group 0 (vehicule control group) : 10 males and 10 females
Group 1 (positive control group) : 5 males and 5 females
Group 2 (SR 48941-treated group) : 10 males and 10 females - Control animals:
- yes
- Positive control(s):
- Cyclophosphamide (35 mg/kg) by IP route in aqeous solution
Examinations
- Tissues and cell types examined:
- Animals were killed by cervical dislocation 24 and 48 hours after treatment for groups 0 and 2 (5 animals per sex per group at each time of sacrifice), and 24 hours after treatment for group 1 (5 animals per sex).
- Details of tissue and slide preparation:
- After sacrifice, one femur was removed from each animal, severed at the proximal end, and 1.5 ml of newborn calf serum supplemented with 25 ml EDTA was injected in each bone marrow canal. Bone marrow cells (1 ml) were then placed in an hemolysis tube and purified by elution through a alpha cellulose and Sigmacell.
The eluate was diluted in Hank's balanced salt solution (HBSS), then centrifuged. The pellet was then suspended in HBSS supplemented with 2% albumin bovine. After cells were counted, the suspension was diluted to approximately 2.3 x 10^6 cells per ml. Smears were performed by cytocentrifugation of an aliquot of this diluted cell suspension.
At least three smears were performed for each animal. The 0.5 ml bone marrow cells remaining were kept for the preparation of whole medular smears. - Statistics:
- 1- An appropriate transformation is applied to data to stabilize variances.
2- Equality of the group means is verified by a three cross-factor ANOVA: group, sex and time of sacrifice (3-ANOVA)
If the analysis does not reveal any significant difference as regards the group factor or interactions including the group, the intergroup means are equal. If it does, the analysis is carried on with Bonferroni's test.
3- Pair-wise comparisons of means between treated groups and the control group are performed using Bonferroni's test. When a significant interaction is recorded, comparisons are made per sex or time of sacrifice. If the interaction is not significant, comparisons are made regardless of the sex or time of sacrifice.
If Bonferroni's test does not reveal any significant difference, the means for the treated and control group are equal. If it does, the means of the treated group and the control group are different.
Results and discussion
Test resultsopen allclose all
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- PCE/NCE= 52.6 % (24 hrs) and 45.0 % (48 hrs). The decrease in the PCE/NCE % indicates a medullary cytotoxicity.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- PCE/NCE= 38.8 % (24 hrs) and 47.9 % (48 hrs). The decrease in the PCE/NCE % indicates a medullary cytotoxicity.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No cases of mortality or clinical signs were recorded throughout the study.
No statistically significant increase in the MPCE frequency was observed whatever the sex or time of sacrifice. The mean MCPE frequency in the bone marrow was 1.7 per thousand (males and females combined) 24 hours after dosing (with a range of 0.9 to 2.1) and 1.9 per thousand 48 hours after dosing (with a range of 0.5 to 2.7).
Corresponding values for the vehicle group were 2.0 per thousand, 24 hours after dosing (with a range of 1.4 to 2.9) and 1.9 per thousand, 48 hours after dosing (with arange of 0.8 to 2.9).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In conclusion, SR 49841 did not reveal any in vivo clastogenic activity in the micronucleus test in rats.
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