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Diss Factsheets
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EC number: 200-858-8 | CAS number: 75-29-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study planned
- Study period:
- Including a dose range finding study, should be available approximately 2 years following first dosing after approval to run the test.
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Isopropylchloride (2-chloropropane)
- Name of the substance for which the testing proposal will be used [if different from tested substance]: See above
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies
So far no extended one generation or two-generation study is known for isopropylchloride
- Available non-GLP studies
See above
- Historical human data
For isopropylchloride no reproductive effects were reported so far to our knowledge.
- (Q)SAR
No valid models currently known to us to predict reproductive toxicity, suitable to replace this study
- In vitro methods
No valid models currently known to us to predict reproductive toxicity, suitable to replace this study
- Weight of evidence
So far, no extended one generation or two-generation study is known for isopropylchloride
- Grouping and read-across
So far, no extended one generation or two-generation study is known for isopropylchloride or sufficiently appropriate surrogate substances
- Substance-tailored exposure driven testing [if applicable]
Considering that the substance is almost exclusively used by industrial workers with low exposure and the high vapour pressure of the substance, an inhalation study appears appropriate, addressing the most likely exposure (besides incidences).
- Approaches in addition to above [if applicable]
- Other reasons [if applicable]
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- in tonnage band >1000 T/a the Extended One Generation Reproductive Toxicity Study is a mandatory data endpoint. Although toxicokinetic absorption is expected being low, exposure of industrial workers cannot be fully excluded and vapour pressure of the substance is high. However, the low acute and repeat-dose toxicity as well as insignificant differences between mutagenicity data with and without metabolic activation do suggest, that absorption and metabolism are not too relevant.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
Inhalation exposure (via whole body) is suggested as dermal and oral exposure are not very relevant in industrial settings and considering the high vapour pressure of the substance. Any amendments by additional modules (neurotoxicity or immunotoxicity) or additional cohorts do not appear appropriate, as neither such effects are expected and no information on such effects have become known, following years of continuous use in high tonnages.
More details can be found in attached document!
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- GLP compliance:
- yes
- Justification for study design:
- SPECIFICATION OF STUDY DESIGN FOR EXTENDED ONE-GENERATION REPRODUCTION TOXICITY STUDY WITH JUSTIFICATIONS [please address all points below]:
- Premating exposure duration for parental (P0) animals
According to OECD443 2 weeks during pre-mating (males and females), 2 weeks during mating (males and females) and 6 weeks (males post-mating) and females during pregnancy and lactation
- Basis for dose level selection
based on a 14 days range finding study to be performed
- Inclusion/exclusion of extension of Cohort 1B
not required (see attached document)
- Termination time for F2
not required (see attached document)
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B
not required (see attached document)
- Inclusion/exclusion of developmental immunotoxicity Cohort 3
not required (see attached document)
- Route of administration
inhalation exposure via whole body application is proposed (see attached document)
- Other considerations, e.g. on choice of species, strain, vehicle and number of animals
rats as preferred species are proposed and numbers of animals to follow recommendation in OECD guideline (for more details see attached document)
Test material
- Reference substance name:
- 2-chloropropane
- EC Number:
- 200-858-8
- EC Name:
- 2-chloropropane
- Cas Number:
- 75-29-6
- Molecular formula:
- C3H7Cl
- IUPAC Name:
- 2-chloropropane
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Isopropyl chloride
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: vapour
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.