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EC number: 438-020-0 | CAS number: 3159-07-7
- 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:
- 10 Sept 2002 - 25 Oct 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to Guideline OECD 474
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 438-020-0
- EC Name:
- -
- Cas Number:
- 3159-07-7
- Molecular formula:
- Hill formula: C13 H9 NOS
- IUPAC Name:
- 2-thia-9-azatricyclo[9.4.0.0³,⁸]pentadeca-1(11),3,5,7,12,14-hexaen-10-one
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: Male 8 - 10 weeks.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- 1% carboxymethyl cellulose in water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
An individual stock suspension of the test substance was prepared for each group of animals as close to the time of dosing as possible. The dosing volume was 10 ml/kg bodyweight - Duration of treatment / exposure:
- 24 or 48 hours
- Frequency of treatment:
- Single dose
- Post exposure period:
- Not relevant
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg; 1000 mg/kg; 500 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide given as a single oral dose, 65 mg/kg, in 1% carboxy methyl cellulose in water
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- Femurs were removed and stripped clean of muscle. The iliac end of the femur was removed and a fine paint brush was rinsed in saline, and wetted with a solution of albumin (6% w/v in physiological saline). This was then dipped into the marrow canal and two smears were painted on a labelled clean, dry microscope slide.
This procedure wasrepeated to give four smears of marrow per slide.
The slides were allowed to ar dry and were stained with polychrome methylene blue and eosin using an automatic staining machine. - Evaluation criteria:
- Criteria for identificaiton of micronuclei are as described by Schmid (1976):
i)Spherical (or rounded) with well-defined edges
ii)Diameters of not less than approx 1/20 of a polychromatic erythrocyte diameter
iii)Dark purple/dark blue staining
iv)Lie in the same plane as the polychromatic erythrocyte in which it is contained
To be considered positive there must be a statistically and biological significant increase in the incidence of micronucleated polychromatic erythrocytes which is in excess of a three-fold increase when compared with both historical and concurrent vehicle control incidences. - Statistics:
- Analyses were carried out using the MIXED procedure in SAS (1999). Each treatment group mean was compared with the control group mean at the corresponding sampling time using a one-sided Student's test, based on the error mean square in the analysis.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- In the dose finding study, both male and female mice were used. No deaths were seen up to 2000mg/kg (i.p.) but some clinical signs were seen at the highest dose. There was no difference between the sexes so only males were used for the main study.
Any other information on results incl. tables
Group |
Treatment |
Dose |
Mean incidence of MPE/1000 PE +- SD |
|
24 hours |
48 hours
|
|||
11 |
Vehicle Control |
10 ml/kg |
0.9 ± 0.42 |
0.7 ± 0.27 |
12 |
Cyclophsphamide |
65 mg/kg |
20.9 ±10.43 |
|
13 |
Lactam 204,636 |
2000 mg/kg |
0.6 ±0.65 |
0.5 ±0.35 |
14 |
Lactam 204,636 |
1000 mg/kg |
0.8 ±0.57 |
|
15 |
Lactam 204,636 |
500 mg/kg |
1.1 ±0.22 |
|
MPE = micronucleated polychromatic erythrocytes
PE = polychromatic erythrocytes
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the conditions of the test, Lactam 204,636 is not clastogenic in the mouse bone marrow micronucleous test
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